Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00482170

Collaborator

(none)

421

Enrollment

Locations

Arms

Duration (Months)

5.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Device: Enbrel (etanercept) Device: Etanercept	Phase 3

Detailed Description

For the measures of patient's satisfaction with and perceptions of, their device, standard Likert scales are used. This allows the magnitude of individual's perceptions and satisfaction to be measured on a multipoint scale anchored at each end. In addition, the study will describe patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e.g. ease of use, convenience, injection site pain, injection anxiety, injection confidence) will be captured using a questionnaire. The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, demographics, social and educational status psychological status, willingness to self-manage, injection experience) and Psoriasis characteristics (e.g. disease severity, disease duration, co morbidities, prior treatment, quality of life). The study will also take the opportunity to measure health outcome measures as there may be important differences in cost of training and patient support between the two devices.

Study Design

Study Type:

Interventional

Actual Enrollment :

421 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-injector and the Etanercept Prefilled Syringe) in Patients With Psoriasis.

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Arm 1: Enbrel 50 mg Prefilled Syringe	Device: Enbrel (etanercept) Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
Active Comparator: 2 Arm 2 Enbrel 50 mg Autoinjector	Device: Etanercept Arm 2 = Enbrel 50 mg Autoinjector twice weekly

Arm

Intervention/Treatment

Experimental: 1

Arm 1: Enbrel 50 mg Prefilled Syringe

Device: Enbrel (etanercept)

Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly

Active Comparator: 2

Arm 2 Enbrel 50 mg Autoinjector

Device: Etanercept

Arm 2 = Enbrel 50 mg Autoinjector twice weekly

Outcome Measures

Primary Outcome Measures

Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population [Week 12]
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population [Week 12]
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.

Secondary Outcome Measures

Percentage of Participants Satisfied With Injection Device [Baseline, Week 4 and Week 12]
Participant satisfaction was assessed by asking the question "Are you satisfied with your injection device? and using a dichotomous response: Yes or No.
Influence of Age on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=<) 36 years, greater than (>) 36 years to 45 years, > 45 years to 55 years, > 55 years.
Influence of Gender on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.
Influence of Socio-educational Status on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =< 4, > 4 to 7, > 7 to 10, > 10 for HAD-A and =< 3, > 3 to 5, > 5 to 8, > 8 for HAD-D.
Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =< 47.4, > 47.4 to 56.4, > 56.4 to 68.5, > 68.5.
Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.
Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =< 11 years, > 11 years to 19 years, > 19 years to 28 years, > 28 years.
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =< 3, > 3 to 4, > 4.
Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =< 11.2, > 11.2 to 16.2, > 16.2 to 21.9, > 21.9.
Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =< 48, > 48 to 67.25, > 67.25 to 84, > 84.
Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant's global assessment of psoriasis scores observed. Participants were divided into quarters: =< 63, > 63 to 76, > 76 to 88, > 88.
Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =< 8, > 8 to 13, > 13 to 18, > 18.
Influence of Co-morbidities on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.
Influence of Prior Injection Experience on Participant Satisfaction With Injection Device [Week 12]
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device [Baseline, Week 4 and Week 12]
Ease of use of injection device was assessed by participant's response to question, "How easy was it to perform an injection with this device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device [Baseline, Week 4 and Week 12]
Ease of use of injection device was assessed by participant's response to question, "How easy was it to use the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device [Baseline, Week 4 and Week 12]
Ease of use of injection device was assessed by participant's response to question, "How easy was it to dispose of the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete [Baseline, Week 4 and Week 12]
Ease of use of injection device was assessed by participant's response to question, "How easy is it to know when the injection is completed?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting [Baseline, Week 4 and Week 12]
Ease of use of injection device was assessed by participant's response to question, "How easy is it to hold the device whilst injecting?" scored on a 5-point Likert scale (0= very easy to 4= very difficult)
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting [Baseline, Week 4 and Week 12]
Ease of use of injection device was assessed by participant's response to question, "Did you feel any hand discomfort whilst using the device?" scored on a 5-point Likert scale (0= none to 4= extreme).
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) [Baseline, Week 4 and Week 12]
Ease of Use of Injection Device was assessed by participant's response to question, "How long does it take to perform the injection, including any preparation and disposal?" where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'.
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity [Baseline, Week 4 and Week 12]
Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity [Baseline, Week 4 and Week 12]
Convenience of injection device was assessed by participant's response to question, "Do you think injecting etanercept will interfere with your usual daily activities?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling [Baseline, Week 4 and Week 12]
Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections [Baseline, Week 4 and Week 12]
Confidence in injection device was assessed by participant's response to question, "How confident are you in your management of your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time [Baseline, Week 4 and Week 12]
Confidence in injection device was assessed by participant's response to question, "How confident are you that you inject the right amount of medicine every time?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device [Baseline, Week 4 and Week 12]
Confidence in injection device was assessed by participant's response to question, "How confident are you that you can inject yourself properly with the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process [Baseline, Week 4 and Week 12]
Confidence in injection device was assessed by participant's response to question, "Are you confident that you have good control over the injection process?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection [Baseline, Week 4 and Week 12]
Confidence in injection device was assessed by participant's response to question, "How confident are you that you injected yourself successfully?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections [Baseline, Week 4 and Week 12]
Fear of Device was assessed by participant's response to question, "How nervous do you feel about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin [Baseline, Week 4 and Week 12]
Fear of Device was assessed by participant's response to question, "How nervous do you feel about inserting the needle into your skin?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device [Baseline, Week 4 and Week 12]
Fear of Device was assessed by participant's response to question, "Do you dislike injecting yourself with this device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection [Baseline, Week 4 and Week 12]
Fear of Device was assessed by participant's response to question, "Are you emotionally distressed or anxious about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Device Characteristics Based on Response to Question Concerning Look of Device [Baseline, Week 4 and Week 12]
Device characteristics were assessed by participant's response to question, "How much do you like the look of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Device Characteristics Based on Response to Question Concerning Feel of Device [Baseline, Week 4 and Week 12]
Device characteristics were assessed by participant's response to question, "How much do you like the feel of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks [Baseline, Week 4 and Week 12]
Device characteristics were assessed by participant's response to question, "How much does the device look like something you would feel comfortable to use?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection [Baseline, Week 4 and Week 12]
Side effects related to administration were assessed by participant's response to question, "Do you experience pain during or immediately after the injection?" scored on a 5-point Likert scale (0= none to 4= severe).
Short Form State-Trait Anxiety Inventory (SF STAI) Global Score [Baseline, Week 4 and Week 12]
SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.
Influence of Age on Participant Perception [Baseline]
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.
Influence of Gender on Participant Perception [Baseline]
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.
Influence of Socio-educational Status on Participant Perception [Baseline]
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception [Baseline]
Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.
Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception [Baseline]
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.
Influence of Prior Injection Experience on Participant Perception [Baseline]
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.
Influence of Prior Self-injection Experience on Participant Perception [Baseline]
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.
Influence of Duration of Psoriasis on Participant Perception [Baseline]
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception [Baseline]
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.
Influence of Psoriasis Area Severity Index (PASI) on Participant Perception [Baseline]
Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.
Influence of Participant's Assessment of General Health on Participant Perception [Baseline]
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant's assessment of general health score was determined for each cluster of participants.
Influence of Participant's Global Assessment of Psoriasis on Participant Perception [Baseline]
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant's assessment of psoriasis score was determined for each cluster of participants.
Influence of Dermatology Life Quality Index (DLQI) on Participant Perception [Baseline]
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.
Influence of Co-morbidities on Participant Perception [Baseline]
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception [Baseline]
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
Aged 18 years or more
Willing and able to self-inject etanercept.
Able to store test drug at 2-8oC.
Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week

for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.

Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.

Exclusion Criteria:

Prior experience of biologics and anti-TNF treatment for their Psoriasis including etanercept.
Sepsis or risk of sepsis.
Current or recent infections, including chronic or localized.
Latex sensitivity.
Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Brugge		Belgium	08000
2	Bruxelles		Belgium	01070
3	Bruxelles		Belgium	01200
4	Edegem		Belgium	B-2650
5	Gent		Belgium	09000
6	Hasselt		Belgium	03500
7	Kapellen		Belgium	02950
8	Liège 1		Belgium	B-4000
9	Hellerup		Denmark	02900
10	Hørsholm		Denmark	02970
11	Roskilde		Denmark	04000
12	Helsinki		Finland	00029 HUS
13	Helsinki		Finland	00250
14	Joensuu		Finland	802 10
15	Tampere		Finland	FIN-33521
16	Le Mans	Cedex	France	72037
17	Limoges		France	87042
18	Montpellier		France	34000
19	Nancy		France	54000
20	Nantes		France	44093
21	Paris		France	75010
22	Pessac		France	33600
23	Pierre Bénite		France	69495
24	Reims		France	51092
25	Toulouse		France	31059
26	Augsburg		Germany	86179
27	Berlin		Germany	10435
28	Berlin		Germany	10827
29	Bonn		Germany	53105
30	Dresden		Germany	01307
31	Duelmen		Germany	48249
32	Erlangen		Germany	91052
33	Freiburg		Germany	79106
34	Goettingen		Germany	37099
35	Greifswald		Germany	17475
36	Hamburg		Germany	20246
37	Koeln		Germany	50931
38	Luebeck		Germany	23538
39	Mainz		Germany	55101
40	Mannheim		Germany	68135
41	Muenchen		Germany	80802
42	Muenster		Germany	48149
43	Tübingen		Germany	72076
44	Wiesbaden		Germany	65199
45	Wuerzburg		Germany	97070
46	Wuerzburg		Germany	D-97080
47	Athens		Greece	54644
48	Athens		Greece
49	Ioannina		Greece	45332
50	Thessaloniki		Greece	54644
51	Szeged		Hungary	06720
52	S. Giovanni Rotondo	Foggia	Italy	71013
53	Terracina	Latina	Italy	ITALY 04019
54	Gallarate	Varese	Italy	21013
55	Capranica	Viterbo	Italy	01012
56	Bologna		Italy	40128
57	Como		Italy	22100
58	Milano		Italy	20122
59	Napoli		Italy	80131
60	Napoli		Italy	80132
61	Padova		Italy
62	Pisa		Italy	56126
63	Breda		Netherlands	4818 CK
64	Nijmegen		Netherlands	06525
65	Vlissingen		Netherlands	4382 EE
66	Bergen		Norway	05021
67	Stavanger		Norway	04068
68	Tromso		Norway	N-9038
69	Elche	Alicante	Spain	03203
70	Santander	Cantabria	Spain	39008
71	Córdoba		Spain	14004
72	Granada		Spain	18012
73	Madrid		Spain	SPAIN 28046
74	Valencia		Spain	46015
75	Danderyd		Sweden	182 88
76	Göteborg		Sweden	41459
77	Linköping		Sweden	SE-581 85
78	Malmö		Sweden	SE-205 02

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00482170

Other Study ID Numbers:

0881A6-3326

First Posted:

Jun 4, 2007

Last Update Posted:

Mar 30, 2012

Last Verified:

Mar 1, 2012

Additional relevant MeSH terms:

Psoriasis

Etanercept

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.
Period Title: Overall Study
STARTED	207	214
Treated	207	211
COMPLETED	192	194
NOT COMPLETED	15	20

Baseline Characteristics

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe	Total
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.	Total of all reporting groups
Overall Participants	206	211	417
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.1 (13.2)	46.1 (13.4)	46.1 (13.3)
Sex: Female, Male (Count of Participants)
Female	71 34.5%	65 30.8%	136 32.6%
Male	135 65.5%	146 69.2%	281 67.4%

Outcome Measures

1. Primary Outcome

Title	Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
Description	Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
Modified intent-to-treat (mITT) analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	198	197
Mean (Standard Deviation) [units on a scale]	8.9 (1.9)	7.6 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority test was performed using the 95 percent (%) confidence interval (CI) of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, one-sided, was done at 2.5% significance level.
	Method	ANOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95% 0.87 to 1.77
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.23
	Estimation Comments

2. Primary Outcome

Title	Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population
Description	Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
Per-protocol (PP) analysis population included participants from mITT population who completed the study with no major protocol violations. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	189	186
Mean (Standard Deviation) [units on a scale]	9.0 (1.9)	7.5 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	ANOVA using a mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority test was performed using the 95% CI of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, one-sided, was done at 2.5% significance level.
	Method	ANOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.41
	Confidence Interval	(2-Sided) 95% 0.95 to 1.87
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.23
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants Satisfied With Injection Device
Description	Participant satisfaction was assessed by asking the question "Are you satisfied with your injection device? and using a dichotomous response: Yes or No.
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training (n=198, 199)	99.5 48.3%	92.5 43.8%
Week 4 (n=190, 190)	98.9 48%	90.0 42.7%
Week 12 (n=188, 179)	98.4 47.8%	88.8 42.1%
Last Observation (n=206, 210)	98.5 47.8%	88.6 42%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: Generalized Estimating Equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.008
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	16.12
	Confidence Interval	(2-Sided) 95% 2.05 to 126.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	11.25
	Confidence Interval	(2-Sided) 95% 2.44 to 51.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.88
	Confidence Interval	(2-Sided) 95% 2.26 to 27.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used for the analysis.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.73
	Confidence Interval	(2-Sided) 95% 2.59 to 29.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Influence of Age on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=<) 36 years, greater than (>) 36 years to 45 years, > 45 years to 55 years, > 55 years.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Last observation carried forward (LOCF) method was used to impute missing values.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
=< 36 years	8.94 (1.95)	7.18 (2.62)
> 36 years to 45 years	8.91 (1.52)	7.41 (2.39)
> 45 years to 55 years	9.06 (1.89)	7.93 (2.90)
> 55 years	8.82 (2.12)	8.07 (2.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.045
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 95% 0.00 to 0.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Influence of Gender on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Male	9.07 (1.59)	7.60 (2.57)
Female	8.70 (2.31)	7.68 (2.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, female and male (reference).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.707
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95% -0.58 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Influence of Socio-educational Status on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Reading /Writing capacity	9.22 (1.62)	7.96 (2.49)
High school /Baccalaureate level	8.80 (1.97)	7.55 (2.73)
University level	8.89 (2.01)	7.24 (2.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, high school or baccalaureate level and reading or writing capacity (reference).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.195
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 95% -0.89 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, university level and reading or writing capacity (reference).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.195
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.55
	Confidence Interval	(2-Sided) 95% -1.21 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
Description	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =< 4, > 4 to 7, > 7 to 10, > 10 for HAD-A and =< 3, > 3 to 5, > 5 to 8, > 8 for HAD-D.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
HAD-A: =< 4	8.98 (1.77)	7.83 (2.42)
HAD-A: > 4 to 7	9.17 (1.48)	7.49 (2.65)
HAD-A: > 7 to 10	8.89 (2.27)	7.42 (2.88)
HAD-A: > 10	8.73 (1.92)	7.74 (2.44)
HAD-D: =< 3	8.68 (2.19)	7.93 (2.39)
HAD-D: > 3 to 5	9.15 (2.04)	7.57 (2.42)
HAD-D: > 5 to 8	9.20 (1.02)	7.50 (2.50)
HAD-D: > 8	8.90 (1.92)	7.31 (3.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, HAD-A: =< 4, HAD-A: > 4 to 7, HAD-A: > 7 to 10 and HAD-A: > 10; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.493
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95% -0.36 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, HAD-D: =< 3, HAD-D: > 3 to 5, HAD-D: > 5 to 8 and HAD-A: > 8; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.287
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95% -0.46 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =< 47.4, > 47.4 to 56.4, > 56.4 to 68.5, > 68.5.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
=< 47.4	8.73 (1.90)	7.05 (2.76)
> 47.4 to 56.4	9.41 (1.14)	7.94 (2.17)
> 56.4 to 68.5	8.28 (2.68)	7.94 (2.70)
> 68.5	9.11 (1.73)	7.93 (2.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.123
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95% -0.04 to 0.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Yes	8.89 (1.92)	7.53 (2.74)
No	8.96 (1.87)	7.66 (2.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, yes and no (reference).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.359
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 95% -0.76 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =< 11 years, > 11 years to 19 years, > 19 years to 28 years, > 28 years.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
=< 11 years	9.09 (1.56)	7.90 (2.22)
> 11 years to 19 years	8.74 (1.99)	7.17 (2.67)
> 19 years to 28 years	9.12 (1.65)	7.72 (2.76)
> 28 years	8.82 (2.29)	7.76 (2.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.693
	Comments
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95% -0.08 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =< 3, > 3 to 4, > 4.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
=< 3	8.87 (1.91)	7.51 (2.48)
> 3 to 4	8.96 (1.97)	7.79 (2.79)
> 4	9.62 (0.51)	7.83 (3.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.170
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95% -0.09 to 0.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =< 11.2, > 11.2 to 16.2, > 16.2 to 21.9, > 21.9.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
=< 11.2	8.41 (2.26)	7.45 (2.33)
> 11.2 to 16.2	9.17 (1.97)	7.81 (2.78)
> 16.2 to 21.9	9.11 (1.66)	7.67 (2.49)
> 21.9	9.00 (1.57)	7.67 (2.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.211
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95% -0.01 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =< 48, > 48 to 67.25, > 67.25 to 84, > 84.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
=< 48	8.54 (2.36)	7.06 (3.26)
> 48 to 67.25	9.15 (1.24)	7.79 (2.61)
> 67.25 to 84	8.70 (2.22)	7.72 (2.06)
> 84	9.42 (1.20)	7.85 (2.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.045
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95% 0.00 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant's global assessment of psoriasis scores observed. Participants were divided into quarters: =< 63, > 63 to 76, > 76 to 88, > 88.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
=< 63	8.79 (1.54)	7.96 (2.18)
> 63 to 76	9.02 (1.91)	7.51 (2.80)
> 76 to 88	8.71 (2.19)	7.70 (2.55)
> 88	9.20 (1.90)	7.33 (2.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.913
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95% -0.12 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =< 8, > 8 to 13, > 13 to 18, > 18.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
=< 8	8.82 (2.18)	7.82 (2.23)
> 8 to 13	8.94 (1.70)	7.71 (2.53)
> 13 to 18	8.81 (2.04)	7.37 (2.72)
> 18	9.14 (1.67)	7.55 (2.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.968
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.00
	Confidence Interval	(2-Sided) 95% -0.17 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Influence of Co-morbidities on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Current tobacco usage: Yes	8.94 (2.11)	7.40 (2.60)
Current tobacco usage: No	8.95 (1.70)	7.76 (2.58)
Current alcohol usage: Yes	8.96 (1.93)	8.06 (2.06)
Current alcohol usage: No	8.94 (1.84)	7.33 (2.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, current tobacco usage: yes and current tobacco usage: no (reference).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.531
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95% -0.61 to 0.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, current alcohol usage: yes and current alcohol usage: no (reference).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.061
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95% -0.02 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Yes	8.95 (1.87)	7.61 (2.59)
No	NA (NA)	9.00 (NA)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, yes and no (reference).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.759
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	-0.73
	Confidence Interval	(2-Sided) 95% -5.37 to 3.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Influence of Prior Injection Experience on Participant Satisfaction With Injection Device
Description	Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Yes	9.05 (1.66)	7.70 (2.58)
No	8.88 (2.01)	7.56 (2.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Statistical analysis was carried out between categories, yes and no (reference).
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.713
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Linear
	Comments

Method of Estimation	Estimation Parameter	Regression coefficient
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95% -0.37 to 0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Description	Ease of use of injection device was assessed by participant's response to question, "How easy was it to perform an injection with this device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0 (n=202, 208)	134 65%	92 43.6%
Baseline- After the training: 1 (n=202, 208)	50 24.3%	72 34.1%
Baseline- After the training: 2 (n=202, 208)	15 7.3%	33 15.6%
Baseline- After the training: 3 (n=202, 208)	3 1.5%	7 3.3%
Baseline- After the training: 4 (n=202, 208)	0 0%	4 1.9%
Week 4: 0 (n=180, 190)	126 61.2%	94 44.5%
Week 4: 1 (n=180, 190)	42 20.4%	62 29.4%
Week 4: 2 (n=180, 190)	6 2.9%	20 9.5%
Week 4: 3 (n=180, 190)	2 1%	12 5.7%
Week 4: 4 (n=180, 190)	4 1.9%	2 0.9%
Week 12: 0 (n=194, 195)	149 72.3%	109 51.7%
Week 12: 1 (n=194, 195)	35 17%	54 25.6%
Week 12: 2 (n=194, 195)	4 1.9%	18 8.5%
Week 12: 3 (n=194, 195)	4 1.9%	9 4.3%
Week 12: 4 (n=194, 195)	2 1%	5 2.4%
Last observation: 0 (n=202, 207)	153 74.3%	115 54.5%
Last observation: 1 (n=202, 207)	36 17.5%	58 27.5%
Last observation: 2 (n=202, 207)	4 1.9%	19 9%
Last observation: 3 (n=202, 207)	5 2.4%	9 4.3%
Last observation: 4 (n=202, 207)	4 1.9%	6 2.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.39
	Confidence Interval	(2-Sided) 95% 1.63 to 3.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4:A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.43
	Confidence Interval	(2-Sided) 95% 1.61 to 3.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.74
	Confidence Interval	(2-Sided) 95% 1.78 to 4.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.51
	Confidence Interval	(2-Sided) 95% 1.66 to 3.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Description	Ease of use of injection device was assessed by participant's response to question, "How easy was it to use the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0 (n=201, 208)	154 74.8%	132 62.6%
Baseline- After the training: 1 (n=201, 208)	39 18.9%	57 27%
Baseline- After the training: 2 (n=201, 208)	7 3.4%	13 6.2%
Baseline- After the training: 3 (n=201, 208)	1 0.5%	5 2.4%
Baseline- After the training: 4 (n=201, 208)	0 0%	1 0.5%
Week 4: 0 (n=179, 189)	137 66.5%	122 57.8%
Week 4: 1 (n=179, 189)	32 15.5%	54 25.6%
Week 4: 2 (n=179, 189)	4 1.9%	6 2.8%
Week 4: 3 (n=179, 189)	1 0.5%	4 1.9%
Week 4: 4 (n=179, 189)	5 2.4%	3 1.4%
Week 12: 0 (n=189, 195)	154 74.8%	126 59.7%
Week 12: 1 (n=189, 195)	26 12.6%	54 25.6%
Week 12: 2 (n=189, 195)	4 1.9%	9 4.3%
Week 12: 3 (n=189, 195)	2 1%	2 0.9%
Week 12: 4 (n=189, 195)	3 1.5%	4 1.9%
Last observation: 0 (n=201, 207)	161 78.2%	134 63.5%
Last observation: 1 (n=201, 207)	26 12.6%	57 27%
Last observation: 2 (n=201, 207)	6 2.9%	10 4.7%
Last observation: 3 (n=201, 207)	5 2.4%	2 0.9%
Last observation: 4 (n=201, 207)	3 1.5%	4 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.88
	Confidence Interval	(2-Sided) 95% 1.22 to 2.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.017
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.73
	Confidence Interval	(2-Sided) 95% 1.10 to 2.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.34
	Confidence Interval	(2-Sided) 95% 1.47 to 3.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.06
	Confidence Interval	(2-Sided) 95% 1.32 to 3.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Description	Ease of use of injection device was assessed by participant's response to question, "How easy was it to dispose of the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0 (n=198, 205)	158 76.7%	141 66.8%
Baseline- After the training: 1 (n=198, 205)	25 12.1%	47 22.3%
Baseline- After the training: 2 (n=198, 205)	12 5.8%	9 4.3%
Baseline- After the training: 3 (n=198, 205)	3 1.5%	2 0.9%
Baseline- After the training: 4 (n=198, 205)	0 0%	6 2.8%
Week 4: 0 (n=173, 189)	131 63.6%	142 67.3%
Week 4: 1 (n=173, 189)	29 14.1%	34 16.1%
Week 4: 2 (n=173, 189)	5 2.4%	5 2.4%
Week 4: 3 (n=173, 189)	4 1.9%	5 2.4%
Week 4: 4 (n=173, 189)	4 1.9%	3 1.4%
Week 12: 0 (n=187, 195)	150 72.8%	148 70.1%
Week 12: 1 (n=187, 195)	21 10.2%	34 16.1%
Week 12: 2 (n=187, 195)	6 2.9%	9 4.3%
Week 12: 3 (n=187, 195)	4 1.9%	2 0.9%
Week 12: 4 (n=187, 195)	6 2.9%	2 0.9%
Last observation: 0 (n=202, 210)	161 78.2%	161 76.3%
Last observation: 1 (n=202, 210)	23 11.2%	36 17.1%
Last observation: 2 (n=202, 210)	6 2.9%	9 4.3%
Last observation: 3 (n=202, 210)	5 2.4%	2 0.9%
Last observation: 4 (n=202, 210)	7 3.4%	2 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.025
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.68
	Confidence Interval	(2-Sided) 95% 1.07 to 2.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.936
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95% 0.63 to 1.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.420
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95% 0.75 to 1.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.625
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95% 0.71 to 1.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Description	Ease of use of injection device was assessed by participant's response to question, "How easy is it to know when the injection is completed?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0 (n=201, 207)	140 68%	129 61.1%
Baseline- After the training: 1 (n=201, 207)	44 21.4%	62 29.4%
Baseline- After the training: 2 (n=201, 207)	13 6.3%	10 4.7%
Baseline- After the training: 3 (n=201, 207)	3 1.5%	4 1.9%
Baseline- After the training: 4 (n=201, 207)	1 0.5%	2 0.9%
Week 4: 0 (n=175, 189)	124 60.2%	123 58.3%
Week 4: 1 (n=175, 189)	40 19.4%	50 23.7%
Week 4: 2 (n=175, 189)	5 2.4%	8 3.8%
Week 4: 3 (n=175, 189)	2 1%	5 2.4%
Week 4: 4 (n=175, 189)	4 1.9%	3 1.4%
Week 12: 0 (n=194, 192)	147 71.4%	137 64.9%
Week 12: 1 (n=194, 192)	40 19.4%	38 18%
Week 12: 2 (n=194, 192)	4 1.9%	9 4.3%
Week 12: 3 (n=194, 192)	0 0%	6 2.8%
Week 12: 4 (n=194, 192)	3 1.5%	2 0.9%
Last Observation: 0 (n=204, 210)	155 75.2%	151 71.6%
Last Observation: 1 (n=204, 210)	42 20.4%	42 19.9%
Last Observation: 2 (n=204, 210)	4 1.9%	9 4.3%
Last Observation: 3 (n=204, 210)	0 0%	6 2.8%
Last Observation: 4 (n=204, 210)	3 1.5%	2 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.210
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.30
	Confidence Interval	(2-Sided) 95% 0.86 to 1.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.227
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95% 0.85 to 2.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.220
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95% 0.84 to 2.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.249
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.29
	Confidence Interval	(2-Sided) 95% 0.84 to 2.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Description	Ease of use of injection device was assessed by participant's response to question, "How easy is it to hold the device whilst injecting?" scored on a 5-point Likert scale (0= very easy to 4= very difficult)
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0 (n=199, 206)	134 65%	100 47.4%
Baseline- After the training: 1 (n=199, 206)	48 23.3%	72 34.1%
Baseline- After the training: 2 (n=199, 206)	15 7.3%	24 11.4%
Baseline- After the training: 3 (n=199, 206)	2 1%	8 3.8%
Baseline- After the training: 4 (n=199, 206)	0 0%	2 0.9%
Week 4: 0 (n=179, 190)	114 55.3%	83 39.3%
Week 4: 1 (n=179, 190)	45 21.8%	59 28%
Week 4: 2 (n=179, 190)	14 6.8%	33 15.6%
Week 4: 3 (n=179, 190)	3 1.5%	12 5.7%
Week 4: 4 (n=179, 190)	3 1.5%	3 1.4%
Week 12: 0 (n=193, 196)	133 64.6%	101 47.9%
Week 12: 1 (n=193, 196)	51 24.8%	55 26.1%
Week 12: 2 (n=193, 196)	4 1.9%	27 12.8%
Week 12: 3 (n=193, 196)	1 0.5%	10 4.7%
Week 12: 4 (n=193, 196)	4 1.9%	3 1.4%
Last observation: 0 (n=203, 209)	140 68%	105 49.8%
Last observation: 1 (n=203, 209)	52 25.2%	61 28.9%
Last observation: 2 (n=203, 209)	6 2.9%	29 13.7%
Last observation: 3 (n=203, 209)	1 0.5%	11 5.2%
Last observation: 4 (n=203, 209)	4 1.9%	3 1.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.18
	Confidence Interval	(2-Sided) 95% 1.48 to 3.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.42
	Confidence Interval	(2-Sided) 95% 1.62 to 3.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.35
	Confidence Interval	(2-Sided) 95% 1.58 to 3.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.42
	Confidence Interval	(2-Sided) 95% 1.64 to 3.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Secondary Outcome

Title	Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Description	Ease of use of injection device was assessed by participant's response to question, "Did you feel any hand discomfort whilst using the device?" scored on a 5-point Likert scale (0= none to 4= extreme).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0 (n=197, 208)	158 76.7%	131 62.1%
Baseline- After the training: 1 (n=197, 208)	26 12.6%	44 20.9%
Baseline- After the training: 2 (n=197, 208)	6 2.9%	20 9.5%
Baseline- After the training: 3 (n=197, 208)	3 1.5%	10 4.7%
Baseline- After the training: 4 (n=197, 208)	4 1.9%	3 1.4%
Week 4: 0 (n=176, 188)	144 69.9%	114 54%
Week 4: 1 (n=176, 188)	18 8.7%	37 17.5%
Week 4: 2 (n=176, 188)	7 3.4%	26 12.3%
Week 4: 3 (n=176, 188)	7 3.4%	8 3.8%
Week 4: 4 (n=176, 188)	0 0%	3 1.4%
Week 12: 0 (n=193, 195)	159 77.2%	125 59.2%
Week 12: 1 (n=193, 195)	24 11.7%	45 21.3%
Week 12: 2 (n=193, 195)	7 3.4%	15 7.1%
Week 12: 3 (n=193, 195)	2 1%	7 3.3%
Week 12: 4 (n=193, 195)	1 0.5%	3 1.4%
Last observation: 0 (n=204, 210)	168 81.6%	138 65.4%
Last observation: 1 (n=204, 210)	25 12.1%	46 21.8%
Last observation: 2 (n=204, 210)	8 3.9%	15 7.1%
Last observation: 3 (n=204, 210)	2 1%	8 3.8%
Last observation: 4 (n=204, 210)	1 0.5%	3 1.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.34
	Confidence Interval	(2-Sided) 95% 1.50 to 3.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.96
	Confidence Interval	(2-Sided) 95% 1.83 to 4.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.58
	Confidence Interval	(2-Sided) 95% 1.62 to 4.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.45
	Confidence Interval	(2-Sided) 95% 1.55 to 3.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Description	Ease of Use of Injection Device was assessed by participant's response to question, "How long does it take to perform the injection, including any preparation and disposal?" where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'.
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After training: less than 5 (n=200, 206)	132 64.1%	129 61.1%
Baseline- After training: 5 to10 (n=200, 206)	43 20.9%	56 26.5%
Baseline- After training: 11 to 20 (n=200, 206)	12 5.8%	14 6.6%
Baseline- After training: 21 to 30 (n=200, 206)	9 4.4%	7 3.3%
Baseline- After training:more than 30 (n=200, 206)	4 1.9%	0 0%
Week 4: less than 5 (n=180, 189)	117 56.8%	121 57.3%
Week 4: 5 to 10 (n=180, 189)	36 17.5%	41 19.4%
Week 4: 11 to 20 (n=180, 189)	14 6.8%	16 7.6%
Week 4: 21 to 30 (n=180, 189)	8 3.9%	10 4.7%
Week 4: more than 30 (n=180, 189)	5 2.4%	1 0.5%
Week 12: less than 5 (n=192, 196)	124 60.2%	132 62.6%
Week 12: 5 to 10 (n=192, 196)	44 21.4%	40 19%
Week 12: 11 to 20 (n=192, 196)	12 5.8%	12 5.7%
Week 12: 21 to 30 (n=192, 196)	6 2.9%	7 3.3%
Week 12: more than 30 (n=192, 196)	6 2.9%	5 2.4%
Last observation: less than 5 (n=204, 210)	131 63.6%	143 67.8%
Last observation: 5 to 10 (n=204, 210)	48 23.3%	43 20.4%
Last observation: 11 to 20 (n=204, 210)	12 5.8%	12 5.7%
Last observation: 21 to 30 (n=204, 210)	7 3.4%	7 3.3%
Last observation: more than 30 (n=204, 210)	6 2.9%	5 2.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.681
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95% 0.73 to 1.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.947
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95% 0.67 to 1.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.604
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95% 0.59 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.430
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95% 0.57 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

26. Secondary Outcome

Title	Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Description	Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	116 56.3%	134 63.5%
Baseline- After the training: 1	34 16.5%	37 17.5%
Baseline- After the training: 2	30 14.6%	20 9.5%
Baseline- After the training: 3	11 5.3%	8 3.8%
Baseline- After the training: 4	12 5.8%	9 4.3%
Week 4: 0	145 70.4%	138 65.4%
Week 4: 1	32 15.5%	34 16.1%
Week 4: 2	6 2.9%	14 6.6%
Week 4: 3	8 3.9%	8 3.8%
Week 4: 4	5 2.4%	7 3.3%
Week 12: 0	133 64.6%	131 62.1%
Week 12: 1	44 21.4%	33 15.6%
Week 12: 2	8 3.9%	17 8.1%
Week 12: 3	4 1.9%	7 3.3%
Week 12: 4	6 2.9%	9 4.3%
Last observation: 0	139 67.5%	144 68.2%
Last observation: 1	46 22.3%	34 16.1%
Last observation: 2	8 3.9%	17 8.1%
Last observation: 3	5 2.4%	7 3.3%
Last observation: 4	8 3.9%	9 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.072
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95% 0.48 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.205
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95% 0.86 to 2.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.434
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95% 0.78 to 1.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.857
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95% 0.69 to 1.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Secondary Outcome

Title	Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Description	Convenience of injection device was assessed by participant's response to question, "Do you think injecting etanercept will interfere with your usual daily activities?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	134 65%	137 64.9%
Baseline- After the training: 1	45 21.8%	45 21.3%
Baseline- After the training: 2	14 6.8%	16 7.6%
Baseline- After the training: 3	6 2.9%	5 2.4%
Baseline- After the training: 4	3 1.5%	5 2.4%
Week 4: 0	150 72.8%	145 68.7%
Week 4: 1	35 17%	37 17.5%
Week 4: 2	4 1.9%	8 3.8%
Week 4: 3	3 1.5%	7 3.3%
Week 4: 4	2 1%	4 1.9%
Week 12: 0	147 71.4%	137 64.9%
Week 12: 1	40 19.4%	39 18.5%
Week 12: 2	6 2.9%	13 6.2%
Week 12: 3	0 0%	4 1.9%
Week 12: 4	2 1%	5 2.4%
Last observation: 0	155 75.2%	148 70.1%
Last observation: 1	42 20.4%	40 19%
Last observation: 2	7 3.4%	13 6.2%
Last observation: 3	0 0%	4 1.9%
Last observation: 4	2 1%	5 2.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.837
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95% 0.70 to 1.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.172
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.37
	Confidence Interval	(2-Sided) 95% 0.87 to 2.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.096
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95% 0.94 to 2.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.164
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.36
	Confidence Interval	(2-Sided) 95% 0.88 to 2.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

28. Secondary Outcome

Title	Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Description	Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	105 51%	98 46.4%
Baseline- After the training: 1	48 23.3%	55 26.1%
Baseline- After the training: 2	34 16.5%	32 15.2%
Baseline- After the training: 3	13 6.3%	20 9.5%
Baseline- After the training: 4	3 1.5%	3 1.4%
Week 4: 0	101 49%	107 50.7%
Week 4: 1	46 22.3%	37 17.5%
Week 4: 2	34 16.5%	33 15.6%
Week 4: 3	9 4.4%	12 5.7%
Week 4: 4	3 1.5%	10 4.7%
Week 12: 0	109 52.9%	101 47.9%
Week 12: 1	44 21.4%	40 19%
Week 12: 2	33 16%	36 17.1%
Week 12: 3	5 2.4%	12 5.7%
Week 12: 4	4 1.9%	8 3.8%
Last observation: 0	115 55.8%	111 52.6%
Last observation: 1	46 22.3%	43 20.4%
Last observation: 2	34 16.5%	37 17.5%
Last observation: 3	7 3.4%	12 5.7%
Last observation: 4	4 1.9%	8 3.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.356
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95% 0.83 to 1.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.737
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95% 0.73 to 1.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.156
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95% 0.90 to 1.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.290
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95% 0.85 to 1.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

29. Secondary Outcome

Title	Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Description	Confidence in injection device was assessed by participant's response to question, "How confident are you in your management of your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	6 2.9%	11 5.2%
Baseline- After the training: 1	13 6.3%	20 9.5%
Baseline- After the training: 2	30 14.6%	31 14.7%
Baseline- After the training: 3	76 36.9%	78 37%
Baseline- After the training: 4	81 39.3%	67 31.8%
Week 4: 0	4 1.9%	3 1.4%
Week 4: 1	9 4.4%	8 3.8%
Week 4: 2	6 2.9%	10 4.7%
Week 4: 3	56 27.2%	75 35.5%
Week 4: 4	121 58.7%	105 49.8%
Week 12: 0	9 4.4%	1 0.5%
Week 12: 1	5 2.4%	7 3.3%
Week 12: 2	7 3.4%	12 5.7%
Week 12: 3	47 22.8%	60 28.4%
Week 12: 4	131 63.6%	117 55.5%
Last observation: 0	9 4.4%	2 0.9%
Last observation: 1	5 2.4%	7 3.3%
Last observation: 2	7 3.4%	13 6.2%
Last observation: 3	49 23.8%	67 31.8%
Last observation: 4	136 66%	122 57.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.065
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95% 0.50 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.100
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95% 0.50 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.298
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95% 0.54 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.148
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95% 0.51 to 1.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

30. Secondary Outcome

Title	Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Description	Confidence in injection device was assessed by participant's response to question, "How confident are you that you inject the right amount of medicine every time?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	5 2.4%	2 0.9%
Baseline- After the training: 1	4 1.9%	7 3.3%
Baseline- After the training: 2	19 9.2%	15 7.1%
Baseline- After the training: 3	67 32.5%	54 25.6%
Baseline- After the training: 4	111 53.9%	129 61.1%
Week 4: 0	5 2.4%	3 1.4%
Week 4: 1	3 1.5%	6 2.8%
Week 4: 2	8 3.9%	3 1.4%
Week 4: 3	53 25.7%	50 23.7%
Week 4: 4	126 61.2%	139 65.9%
Week 12: 0	7 3.4%	2 0.9%
Week 12: 1	4 1.9%	6 2.8%
Week 12: 2	7 3.4%	7 3.3%
Week 12: 3	48 23.3%	43 20.4%
Week 12: 4	132 64.1%	139 65.9%
Last observation: 0	7 3.4%	3 1.4%
Last observation: 1	4 1.9%	6 2.8%
Last observation: 2	8 3.9%	7 3.3%
Last observation: 3	52 25.2%	47 22.3%
Last observation: 4	135 65.5%	148 70.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.098
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.38
	Confidence Interval	(2-Sided) 95% 0.94 to 2.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.311
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 95% 0.82 to 1.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.376
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.21
	Confidence Interval	(2-Sided) 95% 0.79 to 1.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.299
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 95% 0.83 to 1.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

31. Secondary Outcome

Title	Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Description	Confidence in injection device was assessed by participant's response to question, "How confident are you that you can inject yourself properly with the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	4 1.9%	2 0.9%
Baseline- After the training: 1	3 1.5%	7 3.3%
Baseline- After the training: 2	12 5.8%	27 12.8%
Baseline- After the training: 3	70 34%	53 25.1%
Baseline- After the training: 4	117 56.8%	116 55%
Week 4: 0	6 2.9%	3 1.4%
Week 4: 1	0 0%	5 2.4%
Week 4: 2	7 3.4%	10 4.7%
Week 4: 3	47 22.8%	65 30.8%
Week 4: 4	135 65.5%	118 55.9%
Week 12: 0	9 4.4%	1 0.5%
Week 12: 1	1 0.5%	6 2.8%
Week 12: 2	4 1.9%	12 5.7%
Week 12: 3	43 20.9%	54 25.6%
Week 12: 4	142 68.9%	123 58.3%
Last observation: 0	9 4.4%	2 0.9%
Last observation: 1	1 0.5%	6 2.8%
Last observation: 2	4 1.9%	13 6.2%
Last observation: 3	47 22.8%	60 28.4%
Last observation: 4	145 70.4%	130 61.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.494
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95% 0.60 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.036
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95% 0.44 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.079
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95% 0.45 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.063
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95% 0.46 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

32. Secondary Outcome

Title	Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Description	Confidence in injection device was assessed by participant's response to question, "Are you confident that you have good control over the injection process?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	4 1.9%	2 0.9%
Baseline- After the training: 1	2 1%	10 4.7%
Baseline- After the training: 2	11 5.3%	21 10%
Baseline- After the training: 3	72 35%	56 26.5%
Baseline- After the training: 4	113 54.9%	117 55.5%
Week 4: 0	3 1.5%	3 1.4%
Week 4: 1	3 1.5%	4 1.9%
Week 4: 2	8 3.9%	9 4.3%
Week 4: 3	49 23.8%	62 29.4%
Week 4: 4	131 63.6%	122 57.8%
Week 12: 0	6 2.9%	2 0.9%
Week 12: 1	3 1.5%	5 2.4%
Week 12: 2	6 2.9%	10 4.7%
Week 12: 3	43 20.9%	52 24.6%
Week 12: 4	141 68.4%	127 60.2%
Last observation: 0	6 2.9%	2 0.9%
Last observation: 1	3 1.5%	5 2.4%
Last observation: 2	8 3.9%	10 4.7%
Last observation: 3	45 21.8%	59 28%
Last observation: 4	144 69.9%	135 64%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.628
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95% 0.62 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.203
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95% 0.51 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.222
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95% 0.51 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.263
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% 0.53 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

33. Secondary Outcome

Title	Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Description	Confidence in injection device was assessed by participant's response to question, "How confident are you that you injected yourself successfully?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	3 1.5%	1 0.5%
Baseline- After the training: 1	2 1%	8 3.8%
Baseline- After the training: 2	16 7.8%	22 10.4%
Baseline- After the training: 3	69 33.5%	54 25.6%
Baseline- After the training: 4	115 55.8%	122 57.8%
Week 4: 0	3 1.5%	2 0.9%
Week 4: 1	3 1.5%	3 1.4%
Week 4: 2	5 2.4%	12 5.7%
Week 4: 3	60 29.1%	52 24.6%
Week 4: 4	124 60.2%	132 62.6%
Week 12: 0	5 2.4%	2 0.9%
Week 12: 1	3 1.5%	4 1.9%
Week 12: 2	1 0.5%	10 4.7%
Week 12: 3	55 26.7%	49 23.2%
Week 12: 4	135 65.5%	132 62.6%
Last observation: 0	5 2.4%	2 0.9%
Last observation: 1	3 1.5%	4 1.9%
Last observation: 2	2 1%	12 5.7%
Last observation: 3	58 28.2%	53 25.1%
Last observation: 4	138 67%	140 66.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.914
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95% 0.70 to 1.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.827
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95% 0.70 to 1.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.712
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95% 0.61 to 1.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.733
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95% 0.62 to 1.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

34. Secondary Outcome

Title	Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Description	Fear of Device was assessed by participant's response to question, "How nervous do you feel about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	92 44.7%	80 37.9%
Baseline- After the training: 1	59 28.6%	54 25.6%
Baseline- After the training: 2	29 14.1%	39 18.5%
Baseline- After the training: 3	16 7.8%	24 11.4%
Baseline- After the training: 4	10 4.9%	10 4.7%
Week 4: 0	110 53.4%	103 48.8%
Week 4: 1	54 26.2%	51 24.2%
Week 4: 2	22 10.7%	27 12.8%
Week 4: 3	7 3.4%	15 7.1%
Week 4: 4	3 1.5%	5 2.4%
Week 12: 0	125 60.7%	111 52.6%
Week 12: 1	53 25.7%	46 21.8%
Week 12: 2	17 8.3%	19 9%
Week 12: 3	4 1.9%	15 7.1%
Week 12: 4	0 0%	7 3.3%
Last observation: 0	131 63.6%	119 56.4%
Last observation: 1	53 25.7%	48 22.7%
Last observation: 2	18 8.7%	22 10.4%
Last observation: 3	4 1.9%	15 7.1%
Last observation: 4	0 0%	7 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.090
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.36
	Confidence Interval	(2-Sided) 95% 0.95 to 1.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.154
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95% 0.90 to 1.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.037
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.51
	Confidence Interval	(2-Sided) 95% 1.02 to 2.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.028
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.53
	Confidence Interval	(2-Sided) 95% 1.05 to 2.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

35. Secondary Outcome

Title	Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Description	Fear of Device was assessed by participant's response to question, "How nervous do you feel about inserting the needle into your skin?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	102 49.5%	82 38.9%
Baseline- After the training: 1	44 21.4%	49 23.2%
Baseline- After the training: 2	32 15.5%	38 18%
Baseline- After the training: 3	17 8.3%	22 10.4%
Baseline- After the training: 4	10 4.9%	16 7.6%
Week 4: 0	110 53.4%	93 44.1%
Week 4: 1	61 29.6%	54 25.6%
Week 4: 2	13 6.3%	29 13.7%
Week 4: 3	10 4.9%	18 8.5%
Week 4: 4	1 0.5%	7 3.3%
Week 12: 0	115 55.8%	105 49.8%
Week 12: 1	59 28.6%	47 22.3%
Week 12: 2	19 9.2%	19 9%
Week 12: 3	6 2.9%	19 9%
Week 12: 4	0 0%	7 3.3%
Last observation: 0	121 58.7%	112 53.1%
Last observation: 1	59 28.6%	52 24.6%
Last observation: 2	20 9.7%	20 9.5%
Last observation: 3	6 2.9%	20 9.5%
Last observation: 4	0 0%	7 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.022
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.53
	Confidence Interval	(2-Sided) 95% 1.06 to 2.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.68
	Confidence Interval	(2-Sided) 95% 1.17 to 2.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.076
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.40
	Confidence Interval	(2-Sided) 95% 0.97 to 2.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.049
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95% 1.00 to 2.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

36. Secondary Outcome

Title	Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Description	Fear of Device was assessed by participant's response to question, "Do you dislike injecting yourself with this device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	129 62.6%	103 48.8%
Baseline- After the training: 1	43 20.9%	40 19%
Baseline- After the training: 2	22 10.7%	29 13.7%
Baseline- After the training: 3	10 4.9%	22 10.4%
Baseline- After the training: 4	2 1%	12 5.7%
Week 4: 0	135 65.5%	96 45.5%
Week 4: 1	42 20.4%	52 24.6%
Week 4: 2	15 7.3%	33 15.6%
Week 4: 3	0 0%	11 5.2%
Week 4: 4	2 1%	9 4.3%
Week 12: 0	143 69.4%	112 53.1%
Week 12: 1	39 18.9%	39 18.5%
Week 12: 2	13 6.3%	28 13.3%
Week 12: 3	1 0.5%	11 5.2%
Week 12: 4	3 1.5%	7 3.3%
Last observation: 0	150 72.8%	119 56.4%
Last observation: 1	39 18.9%	43 20.4%
Last observation: 2	13 6.3%	30 14.2%
Last observation: 3	1 0.5%	12 5.7%
Last observation: 4	3 1.5%	7 3.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.93
	Confidence Interval	(2-Sided) 95% 1.32 to 2.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.63
	Confidence Interval	(2-Sided) 95% 1.78 to 3.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.13
	Confidence Interval	(2-Sided) 95% 1.42 to 3.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.27
	Confidence Interval	(2-Sided) 95% 1.52 to 3.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

37. Secondary Outcome

Title	Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Description	Fear of Device was assessed by participant's response to question, "Are you emotionally distressed or anxious about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	124 60.2%	105 49.8%
Baseline- After the training: 1	45 21.8%	57 27%
Baseline- After the training: 2	28 13.6%	26 12.3%
Baseline- After the training: 3	7 3.4%	11 5.2%
Baseline- After the training: 4	2 1%	7 3.3%
Week 4: 0	124 60.2%	119 56.4%
Week 4: 1	57 27.7%	50 23.7%
Week 4: 2	11 5.3%	21 10%
Week 4: 3	2 1%	9 4.3%
Week 4: 4	1 0.5%	2 0.9%
Week 12: 0	143 69.4%	125 59.2%
Week 12: 1	41 19.9%	42 19.9%
Week 12: 2	12 5.8%	24 11.4%
Week 12: 3	1 0.5%	5 2.4%
Week 12: 4	1 0.5%	2 0.9%
Last observation: 0	149 72.3%	134 63.5%
Last observation: 1	42 20.4%	45 21.3%
Last observation: 2	13 6.3%	25 11.8%
Last observation: 3	1 0.5%	5 2.4%
Last observation: 4	1 0.5%	2 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.057
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.44
	Confidence Interval	(2-Sided) 95% 0.99 to 2.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.151
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95% 0.90 to 1.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.024
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.61
	Confidence Interval	(2-Sided) 95% 1.06 to 2.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.025
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.59
	Confidence Interval	(2-Sided) 95% 1.06 to 2.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

38. Secondary Outcome

Title	Device Characteristics Based on Response to Question Concerning Look of Device
Description	Device characteristics were assessed by participant's response to question, "How much do you like the look of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	4 1.9%	18 8.5%
Baseline- After the training: 1	10 4.9%	21 10%
Baseline- After the training: 2	62 30.1%	90 42.7%
Baseline- After the training: 3	81 39.3%	56 26.5%
Baseline- After the training: 4	49 23.8%	20 9.5%
Week 4: 0	3 1.5%	14 6.6%
Week 4: 1	2 1%	22 10.4%
Week 4: 2	51 24.8%	92 43.6%
Week 4: 3	79 38.3%	46 21.8%
Week 4: 4	58 28.2%	27 12.8%
Week 12: 0	1 0.5%	13 6.2%
Week 12: 1	11 5.3%	20 9.5%
Week 12: 2	43 20.9%	77 36.5%
Week 12: 3	78 37.9%	59 28%
Week 12: 4	66 32%	29 13.7%
Last observation: 0	1 0.5%	14 6.6%
Last observation: 1	11 5.3%	21 10%
Last observation: 2	46 22.3%	82 38.9%
Last observation: 3	79 38.3%	62 29.4%
Last observation: 4	69 33.5%	32 15.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95% 0.24 to 0.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.26
	Confidence Interval	(2-Sided) 95% 0.18 to 0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95% 0.21 to 0.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95% 0.23 to 0.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

39. Secondary Outcome

Title	Device Characteristics Based on Response to Question Concerning Feel of Device
Description	Device characteristics were assessed by participant's response to question, "How much do you like the feel of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	1 0.5%	9 4.3%
Baseline- After the training: 1	9 4.4%	24 11.4%
Baseline- After the training: 2	69 33.5%	92 43.6%
Baseline- After the training: 3	78 37.9%	60 28.4%
Baseline- After the training: 4	49 23.8%	19 9%
Week 4: 0	2 1%	15 7.1%
Week 4: 1	7 3.4%	21 10%
Week 4: 2	58 28.2%	90 42.7%
Week 4: 3	71 34.5%	45 21.3%
Week 4: 4	55 26.7%	30 14.2%
Week 12: 0	4 1.9%	7 3.3%
Week 12: 1	9 4.4%	19 9%
Week 12: 2	46 22.3%	87 41.2%
Week 12: 3	76 36.9%	54 25.6%
Week 12: 4	64 31.1%	31 14.7%
Last observation: 0	4 1.9%	7 3.3%
Last observation: 1	9 4.4%	20 9.5%
Last observation: 2	49 23.8%	94 44.5%
Last observation: 3	77 37.4%	58 27.5%
Last observation: 4	67 32.5%	32 15.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95% 0.27 to 0.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95% 0.21 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95% 0.24 to 0.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 95% 0.24 to 0.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

40. Secondary Outcome

Title	Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Description	Device characteristics were assessed by participant's response to question, "How much does the device look like something you would feel comfortable to use?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training: 0	7 3.4%	32 15.2%
Baseline- After the training: 1	11 5.3%	26 12.3%
Baseline- After the training: 2	68 33%	76 36%
Baseline- After the training: 3	67 32.5%	55 26.1%
Baseline- After the training: 4	53 25.7%	16 7.6%
Week 4: 0	6 2.9%	28 13.3%
Week 4: 1	8 3.9%	22 10.4%
Week 4: 2	51 24.8%	74 35.1%
Week 4: 3	69 33.5%	45 21.3%
Week 4: 4	59 28.6%	32 15.2%
Week 12: 0	7 3.4%	27 12.8%
Week 12: 1	15 7.3%	21 10%
Week 12: 2	47 22.8%	62 29.4%
Week 12: 3	65 31.6%	54 25.6%
Week 12: 4	65 31.6%	34 16.1%
Last observation: 0	7 3.4%	27 12.8%
Last observation: 1	16 7.8%	22 10.4%
Last observation: 2	47 22.8%	68 32.2%
Last observation: 3	67 32.5%	58 27.5%
Last observation: 4	69 33.5%	36 17.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95% 0.24 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95% 0.22 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95% 0.26 to 0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 95% 0.28 to 0.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

41. Secondary Outcome

Title	Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Description	Side effects related to administration were assessed by participant's response to question, "Do you experience pain during or immediately after the injection?" scored on a 5-point Likert scale (0= none to 4= severe).
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the first injection: 0	98 47.6%	109 51.7%
Baseline- After the first injection: 1	65 31.6%	54 25.6%
Baseline- After the first injection: 2	24 11.7%	31 14.7%
Baseline- After the first injection: 3	9 4.4%	8 3.8%
Baseline- After the first injection: 4	3 1.5%	0 0%
Week 4: 0	77 37.4%	88 41.7%
Week 4: 1	60 29.1%	60 28.4%
Week 4: 2	33 16%	31 14.7%
Week 4: 3	22 10.7%	21 10%
Week 4: 4	3 1.5%	1 0.5%
Week 12: 0	76 36.9%	84 39.8%
Week 12: 1	68 33%	70 33.2%
Week 12: 2	30 14.6%	28 13.3%
Week 12: 3	21 10.2%	15 7.1%
Week 12: 4	4 1.9%	1 0.5%
Last observation: 0	79 38.3%	90 42.7%
Last observation: 1	70 34%	72 34.1%
Last observation: 2	31 15%	32 15.2%
Last observation: 3	22 10.7%	16 7.6%
Last observation: 4	4 1.9%	1 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the first injection: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.470
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized estimating equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95% 0.60 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.325
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95% 0.57 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.197
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Generalized Estimating Equations
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% 0.55 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.212
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95% 0.56 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

42. Secondary Outcome

Title	Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
Description	SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Baseline- After the training	11.0 (3.5)	11.2 (3.6)
Week 4	9.9 (3.3)	10.0 (3.5)
Week 12	10.1 (3.2)	10.1 (3.3)
Last observation	10.1 (3.3)	10.1 (3.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Baseline- after the training: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an auto-regressive correlation structure was used to calculate 95% CI.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.515
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	ANOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 95% -0.91 to 0.46
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.35
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 4: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.842
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	ANOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95% -0.74 to 0.60
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.34
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Week 12: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.928
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	ANOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95% -0.67 to 0.61
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.33
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector, Etanercept 50 mg Prefilled Syringe
	Comments	Last observation: ANOVA method was used for the analysis.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.974
	Comments	Statistical testing, 2-sided, was done at 5% significance level.
	Method	ANOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95% -0.62 to 0.64
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.32
	Estimation Comments

43. Secondary Outcome

Title	Influence of Age on Participant Perception
Description	Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied (n=119, 92)	47.9 (12.6)	49.1 (12.7)
Satisfied (n= 56, 65)	42.8 (12.9)	43.9 (13.3)
Less satisfied (n= 20, 41)	42.7 (15.4)	42.5 (14.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated using ANOVA.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated using ANOVA.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	ANOVA
	Comments

44. Secondary Outcome

Title	Influence of Gender on Participant Perception
Description	Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied: Male (n=119, 92)	77 37.4%	67 31.8%
Very satisfied: Female (n=119, 92)	42 20.4%	25 11.8%
Satisfied: Male (n= 56, 65)	37 18%	45 21.3%
Satisfied: Female (n= 56, 65)	19 9.2%	20 9.5%
Less satisfied: Male (n= 20, 41)	13 6.3%	26 12.3%
Less satisfied: Female (n= 20, 41)	7 3.4%	15 7.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.984
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.549
	Comments
	Method	Chi-squared
	Comments

45. Secondary Outcome

Title	Influence of Socio-educational Status on Participant Perception
Description	Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied: Reading/Writing level (n=119, 92)	41 19.9%	32 15.2%
Very satisfied: High school level (n=119, 92)	56 27.2%	43 20.4%
Very satisfied: University level (n=119, 92)	22 10.7%	17 8.1%
Satisfied: Reading/Writing level (n= 56, 65)	12 5.8%	19 9%
Satisfied: High school level (n= 56, 65)	34 16.5%	32 15.2%
Satisfied: University level (n= 56, 65)	10 4.9%	14 6.6%
Less satisfied: Reading/Writing level (n= 20, 41)	10 4.9%	16 7.6%
Less satisfied: High school level (n= 20, 41)	7 3.4%	16 7.6%
Less satisfied: University level (n= 20, 41)	3 1.5%	9 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.158
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.808
	Comments
	Method	Chi-squared
	Comments

46. Secondary Outcome

Title	Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Description	Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied: HAD-A (n=119, 92)	7.0 (3.8)	6.0 (4.6)
Very satisfied: HAD-D (n=119, 92)	5.0 (3.7)	4.0 (3.9)
Satisfied: HAD-A (n= 56, 65)	7.0 (4.3)	7.0 (4.1)
Satisfied: HAD-D (n= 56, 65)	5.5 (4.0)	5.0 (3.3)
Less satisfied: HAD-A (n= 20, 41)	9.2 (3.5)	10.0 (4.2)
Less satisfied: HAD-D (n= 20, 41)	6.5 (4.2)	8.0 (4.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.411
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Kruskal-Wallis
	Comments

47. Secondary Outcome

Title	Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception
Description	Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied (n=116, 91)	58.0 (13.8)	60.5 (14.0)
Satisfied (n= 56, 63)	53.0 (11.7)	57.5 (11.8)
Less satisfied (n= 20, 40)	60.0 (13.9)	52.4 (12.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.039
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	ANOVA
	Comments

48. Secondary Outcome

Title	Influence of Prior Injection Experience on Participant Perception
Description	Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied: with experience (n=119, 92)	47 22.8%	43 20.4%
Very satisfied: without experience (n=119, 92)	72 35%	49 23.2%
Satisfied: with experience (n= 56, 65)	20 9.7%	28 13.3%
Satisfied: without experience (n= 56, 65)	36 17.5%	37 17.5%
Less satisfied: with experience (n= 20, 41)	9 4.4%	16 7.6%
Less satisfied: without experience (n= 20, 41)	11 5.3%	25 11.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.752
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.700
	Comments
	Method	Chi-squared
	Comments

49. Secondary Outcome

Title	Influence of Prior Self-injection Experience on Participant Perception
Description	Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied: with experience (n=119, 92)	23 11.2%	33 15.6%
Very satisfied: without experience (n=119, 92)	96 46.6%	59 28%
Satisfied: with experience (n= 56, 65)	13 6.3%	16 7.6%
Satisfied: without experience (n= 56, 65)	43 20.9%	49 23.2%
Less satisfied: with experience (n= 20, 41)	5 2.4%	9 4.3%
Less satisfied: without experience (n= 20, 41)	15 7.3%	32 15.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.697
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.159
	Comments
	Method	Chi-squared
	Comments

50. Secondary Outcome

Title	Influence of Duration of Psoriasis on Participant Perception
Description	Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied (n=119, 92)	23.3 (13.3)	22.9 (12.1)
Satisfied (n= 56, 65)	17.8 (10.0)	20.6 (10.8)
Less satisfied (n= 20, 41)	16.1 (7.4)	17.1 (9.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	ANOVA
	Comments

51. Secondary Outcome

Title	Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception
Description	Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied (n=119, 92)	3.0 (0.8)	3.0 (0.6)
Satisfied (n= 56, 65)	3.0 (0.7)	3.0 (0.8)
Less satisfied (n= 20, 40)	3.0 (0.7)	3.0 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.652
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Kruskal-Wallis
	Comments

52. Secondary Outcome

Title	Influence of Psoriasis Area Severity Index (PASI) on Participant Perception
Description	Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied (n=118, 92)	17.2 (7.5)	17.9 (8.5)
Satisfied (n= 56, 65)	18.6 (9.8)	17.5 (7.9)
Less satisfied (n= 20, 39)	17.1 (8.0)	15.9 (10.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.560
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.474
	Comments
	Method	ANOVA
	Comments

53. Secondary Outcome

Title	Influence of Participant's Assessment of General Health on Participant Perception
Description	Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant's assessment of general health score was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied (n=117, 90)	64.9 (23.7)	63.8 (27.9)
Satisfied (n= 55, 65)	59.3 (25.3)	70.7 (21.5)
Less satisfied (n= 20, 40)	48.8 (31.2)	60.5 (22.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.089
	Comments
	Method	ANOVA
	Comments

54. Secondary Outcome

Title	Influence of Participant's Global Assessment of Psoriasis on Participant Perception
Description	Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant's assessment of psoriasis score was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied (n=116, 90)	73.5 (17.7)	73.4 (18.0)
Satisfied (n= 55, 65)	69.9 (19.1)	73.3 (19.8)
Less satisfied (n= 20, 39)	72.6 (21.2)	70.8 (26.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.494
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.782
	Comments
	Method	ANOVA
	Comments

55. Secondary Outcome

Title	Influence of Dermatology Life Quality Index (DLQI) on Participant Perception
Description	Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied (n=116, 90)	13.4 (6.8)	13.1 (7.1)
Satisfied (n= 54, 63)	12.4 (6.4)	12.8 (6.0)
Less satisfied (n= 18, 41)	14.6 (6.9)	13.1 (6.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.444
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.947
	Comments
	Method	ANOVA
	Comments

56. Secondary Outcome

Title	Influence of Co-morbidities on Participant Perception
Description	Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied: Tobacco usage- Yes (n=119, 92)	49 23.8%	31 14.7%
Very satisfied: Tobacco usage- No (n=119, 92)	70 34%	61 28.9%
Very satisfied: Alcohol usage- Yes (n=119, 92)	59 28.6%	38 18%
Very satisfied: Alcohol usage- No (n=119, 92)	60 29.1%	54 25.6%
Satisfied: Tobacco usage- Yes (n= 56, 65)	20 9.7%	25 11.8%
Satisfied: Tobacco usage- No (n= 56, 65)	36 17.5%	40 19%
Satisfied: Alcohol usage- Yes (n= 56, 65)	20 9.7%	29 13.7%
Satisfied: Alcohol usage- No (n= 56, 65)	36 17.5%	36 17.1%
Less satisfied: Tobacco usage- Yes (n= 20, 41)	8 3.9%	19 9%
Less satisfied: Tobacco usage- No (n= 20, 41)	12 5.8%	22 10.4%
Less satisfied: Alcohol usage- Yes (n= 20, 41)	6 2.9%	11 5.2%
Less satisfied: Alcohol usage- No (n= 20, 41)	14 6.8%	30 14.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.787
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.379
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Auto-injector
	Comments	p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg auto-injector group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.098
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.166
	Comments
	Method	Chi-squared
	Comments

57. Secondary Outcome

Title	Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Description	Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.

Arm/Group Title	Etanercept 50 mg Auto-injector	Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.	Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Measure Participants	206	211
Very satisfied: Prior medication- Yes (n=119, 92)	119 57.8%	92 43.6%
Very satisfied: Prior medication- No (n=119, 92)	0 0%	0 0%
Satisfied: Prior medication- Yes (n= 56, 65)	56 27.2%	64 30.3%
Satisfied: Prior medication- No (n= 56, 65)	0 0%	1 0.5%
Less satisfied: Prior medication- Yes (n= 20, 41)	20 9.7%	41 19.4%
Less satisfied: Prior medication- No (n= 20, 41)	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etanercept 50 mg Prefilled Syringe
	Comments	p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.535
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

	Etanercept 50 mg Auto-injector		Etanercept 50 mg Prefilled Syringe
Time Frame
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Arm/Group Title	Etanercept 50 mg Auto-injector		Etanercept 50 mg Prefilled Syringe
Arm/Group Description	Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.		Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Etanercept 50 mg Auto-injector		Etanercept 50 mg Prefilled Syringe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/207 (2.9%)		5/211 (2.4%)
Cardiac disorders
Acute myocardial infarction	1/207 (0.5%)		0/211 (0%)
Ear and labyrinth disorders
Vertigo	0/207 (0%)		1/211 (0.5%)
General disorders
Oedema peripheral	1/207 (0.5%)		0/211 (0%)
Infections and infestations
Bursitis infective	1/207 (0.5%)		0/211 (0%)
Joint abscess	0/207 (0%)		1/211 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm	1/207 (0.5%)		0/211 (0%)
Nervous system disorders
Cerebrovascular accident	1/207 (0.5%)		0/211 (0%)
Renal and urinary disorders
Calculus urinary	0/207 (0%)		1/211 (0.5%)
Skin and subcutaneous tissue disorders
Dermatitis exfoliative	1/207 (0.5%)		0/211 (0%)
Surgical and medical procedures
Retinal operation	1/207 (0.5%)		0/211 (0%)
Urinary calculus removal	0/207 (0%)		1/211 (0.5%)
Prostatic operation	0/207 (0%)		1/211 (0.5%)
Other (Not Including Serious) Adverse Events
	Etanercept 50 mg Auto-injector		Etanercept 50 mg Prefilled Syringe
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	94/207 (45.4%)		96/211 (45.5%)
General disorders
Injection site erythema	10/207 (4.8%)		17/211 (8.1%)
Injection site haematoma	10/207 (4.8%)		3/211 (1.4%)
Injection site irritation	6/207 (2.9%)		9/211 (4.3%)
Injection site pain	10/207 (4.8%)		10/211 (4.7%)
Injection site pruritis	3/207 (1.4%)		5/211 (2.4%)
Injection site reaction	18/207 (8.7%)		17/211 (8.1%)
Infections and infestations
Influenza	5/207 (2.4%)		9/211 (4.3%)
Nasopharyngitis	24/207 (11.6%)		27/211 (12.8%)
Upper respiratory tract infection	7/207 (3.4%)		4/211 (1.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	5/207 (2.4%)		2/211 (0.9%)
Nervous system disorders
Headache	13/207 (6.3%)		15/211 (7.1%)
Respiratory, thoracic and mediastinal disorders
Cough	4/207 (1.9%)		5/211 (2.4%)
Skin and subcutaneous tissue disorders
Erythema	4/207 (1.9%)		5/211 (2.4%)
Pruritis	13/207 (6.3%)		6/211 (2.8%)
Psoriasis	5/207 (2.4%)		9/211 (4.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00482170

Other Study ID Numbers:

0881A6-3326

First Posted:

Jun 4, 2007

Last Update Posted:

Mar 30, 2012

Last Verified:

Mar 1, 2012