PROVE: Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00938015
• Collaborator: (none)
• Enrollment: 303
• Location: 1
• Duration (Months): 90
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Psoriatic	Other: Questionnaire; Other: Questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 303 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
PsA Patients (New) New patients	Other: Questionnaire; This is a non-interventional study
PsA Patients CU patients	Other: Questionnaire; This is a non-interventional study

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 [Baseline up to Year 1]

   An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

2. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2 [Year 1 up to Year 2]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

3. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3 [Year 2 up to Year 3]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

4. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4 [Year 3 up to Year 4]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

5. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5 [Year 4 up to Year 5]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

6. Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6 [Year 5 up to Year 6]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary Outcome Measures

1. Percentage of Participants With at Least 1 Adverse Event (AE) Per Year [Baseline up to Year 6]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

2. Incidence of Adverse Events and Serious Adverse Events Per Participant-Year [Baseline up to Month 6, 12, 18, 30, 42, 54, 66]

   Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.

3. Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment [Baseline up to Month 78]

4. Number of Joints With Active Arthritis [Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78]

   Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.

5. Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation [Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78]

   Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.

6. Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation [Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78]

   Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.

7. Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA) [Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78]

   HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type

• At least 18 years old

• Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type

• Physician decides to prescribe Enbrel or patient is already on Enbrel

• Give written informed consent at time of inclusion to study

Exclusion Criteria:

NA

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Leuven		Belgium	3000

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00938015
• Other Study ID Numbers: 0881A-101698; B1801107
• First Posted: Jul 13, 2009
• Last Update Posted: May 27, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Pfizer: postmarketing surveillance; Enbrel; psoriatic arthritis
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic

Study Results

Participant Flow

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Period Title: Overall Study
STARTED	303
COMPLETED	156
NOT COMPLETED	147

Baseline Characteristics

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Overall Participants	303
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	48.29 (10.83)
Sex: Female, Male (Count of Participants)
Female	137 45.2%
Male	166 54.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Baseline up to Year 1

Outcome Measure Data

Analysis Population Description

Safety set included all the participants who signed informed consent form (ICF) and had at least one dose of study medication and had follow-up data.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	301
Number [Percentage of participants]	7.97 2.6%

2. Primary Outcome

Title	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Year 1 up to Year 2

Outcome Measure Data

Analysis Population Description

Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	278
Number [Percentage of participants]	7.91 2.6%

3. Primary Outcome

Title	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Year 2 up to Year 3

Outcome Measure Data

Analysis Population Description

Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	227
Number [Percentage of participants]	4.85 1.6%

4. Primary Outcome

Title	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Year 3 up to Year 4

Outcome Measure Data

Analysis Population Description

Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	198
Number [Percentage of participants]	4.55 1.5%

5. Primary Outcome

Title	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Year 4 up to Year 5

Outcome Measure Data

Analysis Population Description

Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	178
Number [Percentage of participants]	3.37 1.1%

6. Primary Outcome

Title	Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Year 5 up to Year 6

Outcome Measure Data

Analysis Population Description

Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	159
Number [Percentage of participants]	2.52 0.8%

7. Secondary Outcome

Title	Percentage of Participants With at Least 1 Adverse Event (AE) Per Year
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame	Baseline up to Year 6

Outcome Measure Data

Analysis Population Description

Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'n' signifies those participants who were evaluable for this measure at given time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	301
Till Year 1 (n=301)	44.19 14.6%
Year 1 to Year 2 (n=278)	37.77 12.5%
Year 2 to Year 3 (n=227)	33.92 11.2%
Year 3 to Year 4 (n=198)	34.85 11.5%
Year 4 to Year 5 (n=178)	31.46 10.4%
Year 5 to Year 6 (n=159)	21.38 7.1%

8. Secondary Outcome

Title	Incidence of Adverse Events and Serious Adverse Events Per Participant-Year
Description	Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.
Time Frame	Baseline up to Month 6, 12, 18, 30, 42, 54, 66

Outcome Measure Data

Analysis Population Description

Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. 'n' signifies those participants who were evaluable for this measure at given time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	301
Incidence of AEs till Month 6	145.68
Incidence of AEs till Month 12	138.51
Incidence of AEs till Month 18	134.23
Incidence of AEs till Month 30	125.73
Incidence of AEs till Month 42	117.93
Incidence of AEs till Month 54	118.49
Incidence of AEs till Month 66	112.79
Incidence of SAEs till Month 6	9.44
Incidence of SAEs till Month 12	14.54
Incidence of SAEs till Month 18	13.23
Incidence of SAEs till Month 30	14.11
Incidence of SAEs till Month 42	12.23
Incidence of SAEs till Month 54	11.29
Incidence of SAEs till Month 66	10.65

9. Secondary Outcome

Title	Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment
Time Frame	Baseline up to Month 78

Outcome Measure Data

Analysis Population Description

Efficacy set included all the participants who signed ICF.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	303
Number [Percentage of participants]	51.49 17%

10. Secondary Outcome

Title	Number of Joints With Active Arthritis
Description	Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.
Time Frame	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

Outcome Measure Data

Analysis Population Description

Efficacy set included all the participants who signed ICF. 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	302
Baseline (n=302)	11.81 (6.77)
Month 6 (n=288)	2.10 (3.36)
Month 12 (n=260)	1.80 (4.65)
Month 18 (n=261)	1.34 (3.45)
Month 30 (n=215)	1.13 (2.91)
Month 42 (n=189)	0.83 (2.17)
Month 54 (n=169)	0.77 (2.47)
Month 66 (n=152)	0.73 (2.00)
Month 78 (n=5)	1.00 (1.41)

11. Secondary Outcome

Title	Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation
Description	Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.
Time Frame	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

Outcome Measure Data

Analysis Population Description

Efficacy set included all the participants who signed ICF. 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	37
Baseline (n=37)	7.35 (1.46)
Month 6 (n=27)	3.33 (1.84)
Month 12 (n=19)	3.16 (1.83)
Month 18 (n=24)	3.29 (2.42)
Month 30 (n=18)	3.00 (1.64)
Month 42 (n=13)	2.23 (1.42)
Month 54 (n=9)	3.11 (2.57)
Month 66 (n=5)	3.80 (3.03)
Month 78 (n=0)	NA (NA)

12. Secondary Outcome

Title	Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation
Description	Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.
Time Frame	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

Outcome Measure Data

Analysis Population Description

Efficacy set included all the participants who signed ICF. 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	37
Baseline (n=37)	6.51 (1.22)
Month 6 (n=27)	2.44 (1.48)
Month 12 (n=20)	2.35 (1.35)
Month 18 (n=24)	2.50 (1.96)
Month 30 (n=18)	2.22 (1.11)
Month 42 (n=13)	1.77 (0.73)
Month 54 (n=9)	2.11 (1.45)
Month 66 (n=5)	3.40 (2.79)
Month 78 (n=0)	NA (NA)

13. Secondary Outcome

Title	Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)
Description	HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.
Time Frame	Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

Outcome Measure Data

Analysis Population Description

Efficacy set included all the participants who signed ICF. 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
Measure Participants	261
Baseline (n=261)	26.99 (8.94)
Month 6 (n=239)	9.72 (9.37)
Month 12 (n=194)	8.87 (9.51)
Month 18 (n=209)	8.09 (9.20)
Month 30 (n=182)	7.75 (8.93)
Month 42 (n=166)	7.16 (8.63)
Month 54 (n=149)	7.43 (8.40)
Month 66 (n=135)	7.70 (9.09)
Month 78 (n=4)	15.75 (10.31)

Adverse Events

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
Arm/Group Description	Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
All Cause Mortality
	Etanercept
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Etanercept
	Affected / at Risk (%)	# Events
Total	65/301 (21.6%)
Cardiac disorders
Acute myocardial infarction	2/301 (0.7%)
Angina pectoris	1/301 (0.3%)
Atrial fibrillation	3/301 (1%)
Coronary artery disease	1/301 (0.3%)
Ear and labyrinth disorders
Vertigo	1/301 (0.3%)
Vestibular neuronitis	1/301 (0.3%)
Eye disorders
Corneal erosion	1/301 (0.3%)
Diplopia	1/301 (0.3%)
Gastrointestinal disorders
Abdominal pain lower	1/301 (0.3%)
Colitis ulcerative	1/301 (0.3%)
Colonic polyp	1/301 (0.3%)
Crohn's disease	1/301 (0.3%)
Pancreatitis	1/301 (0.3%)
Pancreatitis acute	1/301 (0.3%)
General disorders
Condition aggravated	3/301 (1%)
Fatigue	1/301 (0.3%)
Hepatobiliary disorders
Cholecystitis acute	1/301 (0.3%)
Hepatic failure	1/301 (0.3%)
Hepatic steatosis	1/301 (0.3%)
Infections and infestations
Arthritis bacterial	1/301 (0.3%)
Cellulitis	2/301 (0.7%)
Escherichia sepsis	1/301 (0.3%)
Hepatitis C	1/301 (0.3%)
Herpes zoster ophthalmic	1/301 (0.3%)
Keratitis herpetic	1/301 (0.3%)
Localised infection	1/301 (0.3%)
Osteomyelitis	1/301 (0.3%)
Otitis media	1/301 (0.3%)
Pneumonia	2/301 (0.7%)
Prostatic abscess	1/301 (0.3%)
Respiratory tract infection	1/301 (0.3%)
Septic shock	1/301 (0.3%)
Staphylococcal bacteraemia	1/301 (0.3%)
Urosepsis	1/301 (0.3%)
Injury, poisoning and procedural complications
Femoral neck fracture	1/301 (0.3%)
Ligament rupture	1/301 (0.3%)
Rib fracture	1/301 (0.3%)
Scapula fracture	1/301 (0.3%)
Splenic rupture	1/301 (0.3%)
Subdural haematoma	1/301 (0.3%)
Tendon rupture	3/301 (1%)
Investigations
Hepatic enzyme increased	1/301 (0.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/301 (0.3%)
Arthritis	2/301 (0.7%)
Back pain	2/301 (0.7%)
Bone cyst	1/301 (0.3%)
Bursitis	2/301 (0.7%)
Intervertebral disc protrusion	1/301 (0.3%)
Joint destruction	1/301 (0.3%)
Psoriatic arthropathy	1/301 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/301 (0.3%)
Lung adenocarcinoma metastatic	1/301 (0.3%)
Rectal cancer	2/301 (0.7%)
Nervous system disorders
Amnestic disorder	1/301 (0.3%)
Cerebrovascular accident	1/301 (0.3%)
Cognitive disorder	1/301 (0.3%)
Demyelination	1/301 (0.3%)
Headache	1/301 (0.3%)
Multiple sclerosis	1/301 (0.3%)
Psychiatric disorders
Depression	2/301 (0.7%)
Renal and urinary disorders
Nephrolithiasis	1/301 (0.3%)
Renal colic	1/301 (0.3%)
Renal impairment	1/301 (0.3%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/301 (0.3%)
Alveolitis allergic	1/301 (0.3%)
Dyspnoea	1/301 (0.3%)
Pleural effusion	1/301 (0.3%)
Pneumothorax	1/301 (0.3%)
Pulmonary embolism	1/301 (0.3%)
Sleep apnoea syndrome	2/301 (0.7%)
Surgical and medical procedures
Arthrodesis	1/301 (0.3%)
Bladder operation	1/301 (0.3%)
Bunion operation	1/301 (0.3%)
Cataract operation	1/301 (0.3%)
Cholecystectomy	1/301 (0.3%)
Chondroplasty	1/301 (0.3%)
Hernia repair	1/301 (0.3%)
Internal fixation of fracture	1/301 (0.3%)
Knee arthroplasty	1/301 (0.3%)
Prostatic operation	1/301 (0.3%)
Sinus operation	1/301 (0.3%)
Synovectomy	2/301 (0.7%)
Toe operation	1/301 (0.3%)
Varicose vein operation	1/301 (0.3%)
Vascular disorders
Deep vein thrombosis	2/301 (0.7%)
Other (Not Including Serious) Adverse Events
	Etanercept
	Affected / at Risk (%)	# Events
Total	179/301 (59.5%)
Blood and lymphatic system disorders
Anaemia	1/301 (0.3%)
Iron deficiency anaemia	1/301 (0.3%)
Leukopenia	7/301 (2.3%)
Lymphadenitis	1/301 (0.3%)
Lymphadenopathy	2/301 (0.7%)
Macrocytosis	1/301 (0.3%)
Neutropenia	2/301 (0.7%)
Thrombocytopenia	1/301 (0.3%)
Cardiac disorders
Atrial fibrillation	1/301 (0.3%)
Bradycardia	1/301 (0.3%)
Palpitations	6/301 (2%)
Tachycardia	3/301 (1%)
Ear and labyrinth disorders
Ear pain	2/301 (0.7%)
Vertigo	3/301 (1%)
Endocrine disorders
Hyperthyroidism	1/301 (0.3%)
Hypothyroidism	1/301 (0.3%)
Eye disorders
Conjunctival hyperaemia	1/301 (0.3%)
Conjunctivitis	5/301 (1.7%)
Dry eye	4/301 (1.3%)
Eye irritation	3/301 (1%)
Eye pruritus	2/301 (0.7%)
Glaucoma	1/301 (0.3%)
Lacrimation increased	1/301 (0.3%)
Uveitis	2/301 (0.7%)
Visual acuity reduced	1/301 (0.3%)
Visual disturbance	2/301 (0.7%)
Gastrointestinal disorders
Abdominal discomfort	2/301 (0.7%)
Abdominal pain	1/301 (0.3%)
Abdominal pain upper	8/301 (2.7%)
Aphthous stomatitis	1/301 (0.3%)
Colitis	1/301 (0.3%)
Colonic polyp	2/301 (0.7%)
Constipation	1/301 (0.3%)
Crohn's disease	1/301 (0.3%)
Diarrhoea	16/301 (5.3%)
Dry mouth	1/301 (0.3%)
Dyspepsia	5/301 (1.7%)
Enteritis	1/301 (0.3%)
Epiploic appendagitis	1/301 (0.3%)
Frequent bowel movements	1/301 (0.3%)
Gastric ulcer	3/301 (1%)
Gastritis	1/301 (0.3%)
Gastrointestinal disorder	1/301 (0.3%)
Gastrointestinal pain	1/301 (0.3%)
Gastrooesophagitis	1/301 (0.3%)
Gingivitis	2/301 (0.7%)
Haemorrhoids	2/301 (0.7%)
Hiatus hernia	1/301 (0.3%)
Inguinal hernia	1/301 (0.3%)
Nausea	10/301 (3.3%)
Pancreatitis	1/301 (0.3%)
Periodontitis	1/301 (0.3%)
Reflux oesophagitis	4/301 (1.3%)
Stomach discomfort	1/301 (0.3%)
Toothache	3/301 (1%)
Vomiting	3/301 (1%)
General disorders
Asthenia	2/301 (0.7%)
Chest pain	1/301 (0.3%)
Chills	1/301 (0.3%)
Drug intolerance	1/301 (0.3%)
Fatigue	18/301 (6%)
Haemorrhagic cyst	1/301 (0.3%)
Impaired healing	2/301 (0.7%)
Influenza like illness	9/301 (3%)
Injection site erythema	1/301 (0.3%)
Injection site irritation	1/301 (0.3%)
Injection site pruritus	1/301 (0.3%)
Injection site rash	2/301 (0.7%)
Injection site reaction	1/301 (0.3%)
Malaise	1/301 (0.3%)
Pyrexia	11/301 (3.7%)
Rebound effect	1/301 (0.3%)
Hepatobiliary disorders
Cholelithiasis	1/301 (0.3%)
Cirrhosis alcoholic	1/301 (0.3%)
Hepatic function abnormal	15/301 (5%)
Hepatic steatosis	4/301 (1.3%)
Immune system disorders
Allergy to arthropod sting	1/301 (0.3%)
Atopy	1/301 (0.3%)
Hypersensitivity	2/301 (0.7%)
Seasonal allergy	1/301 (0.3%)
Infections and infestations
Acute tonsillitis	7/301 (2.3%)
Anogenital warts	1/301 (0.3%)
Bronchitis	17/301 (5.6%)
Cystitis	3/301 (1%)
Cystitis escherichia	1/301 (0.3%)
Ear infection	2/301 (0.7%)
Epiglottitis	1/301 (0.3%)
Erysipelas	2/301 (0.7%)
Eye infection	3/301 (1%)
Folliculitis	1/301 (0.3%)
Fungal infection	1/301 (0.3%)
Furuncle	1/301 (0.3%)
Gastroenteritis	7/301 (2.3%)
Gastrointestinal fungal infection	1/301 (0.3%)
Gastrointestinal infection	1/301 (0.3%)
Genital infection male	1/301 (0.3%)
Helicobacter gastritis	2/301 (0.7%)
Herpes simplex	5/301 (1.7%)
Herpes zoster	5/301 (1.7%)
Infection	1/301 (0.3%)
Influenza	15/301 (5%)
Laryngitis	2/301 (0.7%)
Molluscum contagiosum	1/301 (0.3%)
Nail infection	1/301 (0.3%)
Nasopharyngitis	41/301 (13.6%)
Onychomycosis	1/301 (0.3%)
Oral fungal infection	1/301 (0.3%)
Orchitis	1/301 (0.3%)
Otitis externa	1/301 (0.3%)
Otitis media	2/301 (0.7%)
Parotitis	1/301 (0.3%)
Pharyngitis	4/301 (1.3%)
Pneumonia	1/301 (0.3%)
Pneumonia mycoplasmal	1/301 (0.3%)
Respiratory tract infection	4/301 (1.3%)
Respiratory tract infection fungal	1/301 (0.3%)
Respiratory tract infection viral	1/301 (0.3%)
Rhinitis	4/301 (1.3%)
Sinusitis	17/301 (5.6%)
Skin infection	1/301 (0.3%)
Staphylococcal infection	1/301 (0.3%)
Subcutaneous abscess	1/301 (0.3%)
Tinea versicolour	2/301 (0.7%)
Tooth abscess	1/301 (0.3%)
Tooth infection	2/301 (0.7%)
Tracheitis	1/301 (0.3%)
Upper respiratory tract infection	24/301 (8%)
Urethritis	1/301 (0.3%)
Urinary tract infection	8/301 (2.7%)
Vaginal infection	1/301 (0.3%)
Viral infection	1/301 (0.3%)
Viral sinusitis	1/301 (0.3%)
Wound infection	1/301 (0.3%)
Injury, poisoning and procedural complications
Accident at work	1/301 (0.3%)
Animal bite	1/301 (0.3%)
Arthropod bite	1/301 (0.3%)
Arthropod sting	1/301 (0.3%)
Contusion	1/301 (0.3%)
Epicondylitis	4/301 (1.3%)
Fall	7/301 (2.3%)
Foot fracture	3/301 (1%)
Foreign body in eye	1/301 (0.3%)
Fracture	1/301 (0.3%)
Heat stroke	1/301 (0.3%)
Impacted fracture	1/301 (0.3%)
Injury	1/301 (0.3%)
Joint sprain	3/301 (1%)
Meniscus lesion	1/301 (0.3%)
Muscle rupture	1/301 (0.3%)
Patella fracture	1/301 (0.3%)
Radius fracture	1/301 (0.3%)
Road traffic accident	1/301 (0.3%)
Synovial rupture	1/301 (0.3%)
Tendon rupture	2/301 (0.7%)
Thoracic vertebral fracture	1/301 (0.3%)
Tibia fracture	1/301 (0.3%)
Traumatic fracture	1/301 (0.3%)
Ulnar nerve injury	1/301 (0.3%)
Upper limb fracture	1/301 (0.3%)
Wound	4/301 (1.3%)
Wrist fracture	1/301 (0.3%)
Investigations
Alanine aminotransferase increased	2/301 (0.7%)
Aspartate aminotransferase increased	1/301 (0.3%)
Blood cholesterol increased	1/301 (0.3%)
Blood creatine phosphokinase increased	1/301 (0.3%)
Blood glucose increased	1/301 (0.3%)
Blood triglycerides increased	1/301 (0.3%)
Gamma-glutamyltransferase increased	2/301 (0.7%)
Intraocular pressure increased	1/301 (0.3%)
Liver function test abnormal	4/301 (1.3%)
Monoclonal immunoglobulin present	1/301 (0.3%)
Transaminases increased	3/301 (1%)
Weight increased	1/301 (0.3%)
White blood cell count decreased	1/301 (0.3%)
Metabolism and nutrition disorders
Gout	1/301 (0.3%)
Hypercholesterolaemia	2/301 (0.7%)
Hyperglycaemia	1/301 (0.3%)
Hypertriglyceridaemia	1/301 (0.3%)
Hypokalaemia	2/301 (0.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/301 (1%)
Arthritis	1/301 (0.3%)
Arthropathy	1/301 (0.3%)
Back pain	8/301 (2.7%)
Bursitis	7/301 (2.3%)
Fibromyalgia	1/301 (0.3%)
Gouty tophus	1/301 (0.3%)
Groin pain	2/301 (0.7%)
Intervertebral disc degeneration	1/301 (0.3%)
Intervertebral disc disorder	1/301 (0.3%)
Intervertebral disc protrusion	3/301 (1%)
Lumbar spinal stenosis	1/301 (0.3%)
Muscle rigidity	1/301 (0.3%)
Muscle spasms	2/301 (0.7%)
Musculoskeletal chest pain	1/301 (0.3%)
Myalgia	3/301 (1%)
Neck pain	2/301 (0.7%)
Osteoarthritis	4/301 (1.3%)
Osteopenia	1/301 (0.3%)
Pain in extremity	2/301 (0.7%)
Periarthritis	1/301 (0.3%)
Psoriatic arthropathy	4/301 (1.3%)
Rotator cuff syndrome	3/301 (1%)
Spinal osteoarthritis	2/301 (0.7%)
Synovitis	1/301 (0.3%)
Tendon disorder	1/301 (0.3%)
Tendonitis	8/301 (2.7%)
Tenosynovitis	1/301 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal carcinoma	1/301 (0.3%)
Lipoma	1/301 (0.3%)
Skin papilloma	1/301 (0.3%)
Uterine leiomyoma	1/301 (0.3%)
Nervous system disorders
Balance disorder	1/301 (0.3%)
Carotid artery stenosis	1/301 (0.3%)
Carpal tunnel syndrome	2/301 (0.7%)
Disturbance in attention	1/301 (0.3%)
Dizziness	3/301 (1%)
Dizziness postural	1/301 (0.3%)
Headache	17/301 (5.6%)
Memory impairment	1/301 (0.3%)
Paraesthesia	3/301 (1%)
Sciatica	1/301 (0.3%)
Somnolence	1/301 (0.3%)
Syncope	2/301 (0.7%)
Syncope vasovagal	1/301 (0.3%)
Tremor	2/301 (0.7%)
Vertebral artery stenosis	1/301 (0.3%)
Psychiatric disorders
Alcoholism	1/301 (0.3%)
Confusional state	1/301 (0.3%)
Depressed mood	6/301 (2%)
Depression	2/301 (0.7%)
Insomnia	4/301 (1.3%)
Nervousness	1/301 (0.3%)
Obsessive-compulsive disorder	1/301 (0.3%)
Stress	1/301 (0.3%)
Renal and urinary disorders
Calculus urinary	2/301 (0.7%)
Haematuria	1/301 (0.3%)
Micturition urgency	1/301 (0.3%)
Nephroangiosclerosis	1/301 (0.3%)
Nephrolithiasis	4/301 (1.3%)
Renal colic	3/301 (1%)
Renal impairment	4/301 (1.3%)
Urinary incontinence	1/301 (0.3%)
Reproductive system and breast disorders
Balanitis	1/301 (0.3%)
Breast mass	1/301 (0.3%)
Epididymitis	1/301 (0.3%)
Erectile dysfunction	3/301 (1%)
Prostatitis	1/301 (0.3%)
Retracted nipple	1/301 (0.3%)
Uterine polyp	1/301 (0.3%)
Varicocele	1/301 (0.3%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/301 (0.3%)
Cough	19/301 (6.3%)
Diaphragmatic hernia	1/301 (0.3%)
Dry throat	1/301 (0.3%)
Dyspnoea	5/301 (1.7%)
Dyspnoea exertional	2/301 (0.7%)
Hyperventilation	2/301 (0.7%)
Nasal dryness	1/301 (0.3%)
Obliterative bronchiolitis	1/301 (0.3%)
Pharyngolaryngeal pain	9/301 (3%)
Rhinitis allergic	3/301 (1%)
Rhinorrhoea	1/301 (0.3%)
Sneezing	1/301 (0.3%)
Throat irritation	1/301 (0.3%)
Vasomotor rhinitis	1/301 (0.3%)
Skin and subcutaneous tissue disorders
Alopecia	3/301 (1%)
Blister	1/301 (0.3%)
Dermatitis	1/301 (0.3%)
Dermatitis allergic	4/301 (1.3%)
Erythema	1/301 (0.3%)
Hyperhidrosis	2/301 (0.7%)
Neurodermatitis	1/301 (0.3%)
Night sweats	2/301 (0.7%)
Petechiae	2/301 (0.7%)
Pruritus	3/301 (1%)
Psoriasis	10/301 (3.3%)
Rash	6/301 (2%)
Rosacea	1/301 (0.3%)
Skin haemorrhage	1/301 (0.3%)
Skin lesion	1/301 (0.3%)
Toxic skin eruption	1/301 (0.3%)
Urticaria	4/301 (1.3%)
Social circumstances
Tobacco abuse	1/301 (0.3%)
Surgical and medical procedures
Colon polypectomy	1/301 (0.3%)
Finger repair operation	1/301 (0.3%)
Foot operation	1/301 (0.3%)
Gastric banding	1/301 (0.3%)
Knee arthroplasty	1/301 (0.3%)
Knee operation	1/301 (0.3%)
Meniscus removal	1/301 (0.3%)
Osteotomy	1/301 (0.3%)
Shoulder operation	1/301 (0.3%)
Sinus operation	1/301 (0.3%)
Skin lesion excision	1/301 (0.3%)
Toe operation	1/301 (0.3%)
Tooth extraction	5/301 (1.7%)
Vascular disorders
Aortic arteriosclerosis	1/301 (0.3%)
Flushing	1/301 (0.3%)
Haematoma	2/301 (0.7%)
Hypertension	15/301 (5%)
Hypotension	1/301 (0.3%)
Varicose vein	1/301 (0.3%)

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.