ADEQUATE: A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02486302

Collaborator

(none)

1,534

Enrollment

180

Locations

32.6

Actual Duration (Months)

8.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Psoriatic Arthritis Axial Spondyloarthritis Plaque Psoriasis	Drug: Etanercept

Study Design

Study Type:

Observational

Actual Enrollment :

1534 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT

Actual Study Start Date :

Mar 24, 2015

Actual Primary Completion Date :

Dec 11, 2017

Actual Study Completion Date :

Dec 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Observation Group	Drug: Etanercept Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.

Arm

Intervention/Treatment

Observation Group

Drug: Etanercept

Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.

Outcome Measures

Primary Outcome Measures

Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 [Week 12]
Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/h]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale [VAS] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 <2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 [Week 24]
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks [Week 12 up to Week 52]
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks [Week 24 up to Week 52]
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 [Week 12]
PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 [Week 12]
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 [Week 12]
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC <=1; 2) SJC =<1; 3) PASI <= 1 or body surface area (BSA) <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) <= 0.5(HAQ=3.16-[0.028* hannover functional questionnaire [FFbH]); 7) Tender enthesial points <= 1.
Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24 [Week 24]
PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 [Week 24]
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 [Week 24]
DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t<=1; 2) SJC =<1; 3) PASI <= 1 or BSA <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI <= 0.5(HAQ=3.16-[0.028*FFbH); 7) Tender enthesial points <= 1.

Secondary Outcome Measures

Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) [Baseline up to Weeks 12, 24, 36, 52]
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set [Baseline up to Weeks 12, 24, 36, 52]
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set [Baseline up to Weeks 12, 24, 36, 52]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set [Baseline up to Weeks 12, 24, 36, 52]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 <= 2.6 were considered in remission.
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.
Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [Weeks 12, 24, 36, 52]
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [Weeks 12, 24, 36, 52]
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [Weeks 12, 24, 36, 52]
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [Weeks 12, 24, 36, 52]
The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [Weeks 12, 24, 36, 52]
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [Weeks 12, 24, 36, 52]
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [Weeks 12, 24, 36, 52]
FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events [Baseline up to Week 52]
Percentage of participants who discontinued etanercept before completing the study, was reported.
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation [Baseline up to Week 52]
Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 [Weeks 12, 24, 36, 52]
FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicated better daily activities.
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [Baseline, Weeks 12, 24, 36, 52]
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) [Baseline up to Week 24]
PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) [Weeks 12, 24, 36, 52]
PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) [Weeks 12, 24, 36, 52]
PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI < 2; small effect at 2 <=DLQI <= 5; moderate effect at 6 <=DLQI <= 10; very large effect at 11<=DLQI <= 20; extremely large effect at 21 <= DLQI <= 30.
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus".

Other Outcome Measures

Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 [Weeks 12, 24, 36, 52]
To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.
Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) [Baseline]
Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 [Weeks 36, 52]
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52 [Weeks 36, 52]
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC <=1; 2) SJC =<1; 3) PASI <= 1 or body surface area (BSA) <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) <= 0.5(HAQ=3.16-[0.028* hannover functional questionnaire [FFbH]); 7) Tender enthesial points <= 1.
Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of "Clear" or "Almost Clear" And DLQI Total Score of 0 or 1 at Weeks 36 and 52 [Weeks 36, 52]
PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 [Weeks 36, 52]
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 <= 2.6 were considered in remission.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed diagnosis of RA, axSpA, PsA or PsO
No prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics.

Exclusion Criteria:

The contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply.
The additional documentation of the patient in another post-marketing study with etanercept is not permitted.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rheumatologisches MVZ Dresden GmbH im Gesundheitszentrum Dresden - Klotzsche (GZDK)	Dresden	Sachsen	Germany	01109
2	private practise Hemmerich	Aachen		Germany	52062
3	private practise Kurthen	Aachen		Germany	52064
4	Gesundheits- und Pflegezentrum Alsfeld gGmbH	Alsfeld		Germany	36304
5	private practise Kupka	Altenburg		Germany	4600
6	Private Practise Boehm	Altenholz		Germany	24161
7	Private Practise Marycz	Amberg		Germany	92224
8	Klinikum Bad Bramstedt	Bad Bramstedt		Germany	24576
9	private practise Gause	Bad Bramstedt		Germany	24576
10	private practise Messis	Bad Homburg		Germany	61348
11	ACURA Rheumazentrum Bad Kreuznach	Bad Kreuznach		Germany	55543
12	private practise Hesse	Bad Kreuznach		Germany	55543
13	private practise Manger	Bamberg		Germany	96047
14	private practise Balzer	Bautzen		Germany	2625
15	private practise Winkler	Bautzen		Germany	2625
16	private practise Ochs	Bayreuth		Germany	95444
17	private practise Schmitt-Haendle	Bayreuth		Germany	95444
18	Charité Berlin Rheumatologie und Klinische Immunologie	Berlin		Germany	10117
19	Med. Versorgungszentrum Ambulantes Gesundheitszentrum Charite Campus Mitte	Berlin		Germany	10117
20	private practise Hasert	Berlin		Germany	10117
21	Praxis Roßbacher	Berlin		Germany	10247
22	private practise Bozorg	Berlin		Germany	10713
23	private practise Brandt-Jürgens	Berlin		Germany	12161
24	private practise Herzberg	Berlin		Germany	12435
25	private practise Remstedt	Berlin		Germany	12435
26	private practise Seifert	Berlin		Germany	12555
27	private practise Zinke	Berlin		Germany	13055
28	private practise Kors	Berlin		Germany	13086
29	Rheumaklinik Berlin-Buch	Berlin		Germany	13125
30	private practise Miehe	Berlin		Germany	13507
31	private practise Schnorfeil	Berlin		Germany	14163
32	private practise Koelnberger	Bogen		Germany	94327
33	private practise Barth	Borna		Germany	4552
34	private practise Eisterhues	Braunschweig		Germany	38100
35	Private Practise Ramaker-Brunke	Braunschweig		Germany	38114
36	private practise Mall	Bremen		Germany	28195
37	private practise Schwichtenberg	Bremen		Germany	28779
38	Private Practise Wagener	Bruchhausen-Vilsen		Germany	27305
39	private practise Feuchtenberger	Burghausen		Germany	84489
40	private practise Budde	Bückeburg		Germany	31675
41	Mvz Agliomed	Chemnitz		Germany	09130
42	private practise Schneider	Chemnitz		Germany	9116
43	private practise Geißler	Cottbus		Germany	3046
44	private practise Kirrstetter	Deggendorf		Germany	94469
45	Kreiskrankenhaus Demmin GmbH	Demmin		Germany	17109
46	private practise Heidlas	Dessau		Germany	6842
47	private practise Bebnowski	Dortmund		Germany	44309
48	private practise Gerlach	Dresden		Germany	1097
49	private practise Lüthke	Dresden		Germany	1097
50	private practise Fischer	Dresden		Germany	1277
51	private practise Oppers	Dresden		Germany	1277
52	private practise Roch	Dresden		Germany	1277
53	private practise Fendler	Duisburg		Germany	47057
54	private practise Riesopp	Duisburg		Germany	47249
55	private practise Strothmeyer	Düsseldorf		Germany	40211
56	Bezirksklinikum Obermain	Ebensfeld		Germany	96250
57	private practise Berendt	Eberswalde		Germany	16225
58	private practise Pech	Eberswalde		Germany	16225
59	Asklepios MVZ Nord SH GmbH, c/o AK St. Georg	Elmshorn		Germany	25335
60	Elbe Elster MVZ GmbH	Elsterwerda		Germany	49110
61	MVZ Kaestner + Kaestner GbR	Erfurt		Germany	99096
62	private practise Koch	Erfurt		Germany	99096
63	Universitaetsklinikum Essen, Klinik fuer Dermatologie	Essen		Germany	45147
64	private practise Freitag	Falkensee		Germany	14612
65	private practise Häckel	Frankenberg		Germany	9669
66	Klinikum der J.W. Goethe-Universität, Klinik für Dermatologie, Klinische Forschung	Frankfurt/Main		Germany	60590
67	private practise Fritzsch	Frankfurt		Germany	15230
68	private practise Höhne	Fraureuth		Germany	8427
69	private practise Müller	Freiberg		Germany	9588
70	private practise Behringer	Fulda		Germany	36093
71	private practise Bussmann	Geilenkirchen		Germany	52511
72	private practise Zeh	Geislingen A.d. Steige		Germany	73312
73	Private Practice Abahji	Germering		Germany	82110
74	Private Practise	Giessen		Germany	35392
75	Praxis Dres. Dr.Brinkmann, Schult, Samimi-Fard	Gladbeck		Germany	45964
76	private practise Kühne	Haldensleben		Germany	39340
77	private practise Liebhaber	Halle		Germany	6128
78	MVZ Rheumatologie und Autoimmunmedizin GmbH	Hamburg		Germany	20095
79	MVZ Nord GmbH	Hamburg		Germany	21073
80	Katholisches Marienkrankenhaus Geriatrische Klinik	Hamburg		Germany	22087
81	Private Practise Höhle	Hamburg		Germany	22147
82	private practise Dahmen	Hamburg		Germany	22415
83	private practise Weinhardt	Hamburg		Germany	22523
84	private practise Aries	Hamburg		Germany	22767
85	Praxis Praxis Dr. Szabo & Kollegen	Hamm		Germany	59065
86	Private Practise Stille	Hannover		Germany	30161
87	private practise Stein	Hannover		Germany	30167
88	private practise Heilig	Heidelberg		Germany	69120
89	private practise Lassak-Siedl	Heidelberg		Germany	69120
90	Universitätsklinikum Heidelberg	Heidelberg		Germany	69120
91	private Practise Pawlak	Heilbad Heiligenstadt		Germany	37308
92	private practise Schleußner	Heilbad Heiligenstadt		Germany	37308
93	private practise Thies	Herrsching		Germany	82211
94	private practise Meier	Hofheim		Germany	65719
95	private practise Wernicke	Hohen Neuendorf		Germany	16540
96	Private Practice Streibl	Holzkirchen		Germany	83607
97	private practise Kapelle	Hoyerswerda		Germany	2977
98	Uniklinik Jena	Jena		Germany	7747
99	Private Practise Kremers	Jülich		Germany	52428
100	private practise Bräunig	Kahla		Germany	7768
101	Praxis Mauer	Kamenz		Germany	1917
102	Private Practise Turin	Karlstadt		Germany	97753
103	private practise Schwab	Kiel		Germany	24105
104	Office of Parysa Alborz, MD	Koeln		Germany	50937
105	private practise Straub	Kronach		Germany	96317
106	private practise Wilden	Köln		Germany	50825
107	private practise Merkel	Königs Wusterhausen		Germany	15711
108	Kreiskrankenhaus Langenau	Langenau		Germany	89129
109	Boche-Hamann-Teich	Leipzig		Germany	4109
110	private practise Schwarze	Leipzig		Germany	4129
111	private practise Zeiger	Leipzig		Germany	4275
112	private practise Wiemers	Leipzig		Germany	4317
113	private practise Weiß	Lichtenstein		Germany	9350
114	private practise Holst	Ludwigslust		Germany	19288
115	Private Practise Legler	Luebeck		Germany	23564
116	private practise Kudela	Magdeburg		Germany	39104
117	private practise Raschke	Magdeburg		Germany	39104
118	private practise Sieburg	Magdeburg		Germany	39104
119	private practise Weimann	Magdeburg		Germany	39110
120	Hautklinik der Universitätsmedizin Mainz KöR,Clinical Research Center	Mainz		Germany	55101
121	private practise Zimmermann	Malchow		Germany	17213
122	Praxis Roßbach	Mansfeld OT Großörner		Germany	06343
123	private practise Harmuth	Marktredwitz		Germany	95615
124	Private Practise Bödekker	Marl		Germany	45768
125	private practise Reck	Mittelherwigsdorf		Germany	2763
126	private practise Vollmer	Monchengladbach		Germany	41061
127	Stadt Klinikum Muenchen	Munchen		Germany	81925
128	private practise Krüger	München		Germany	81541
129	private practise Raub	Münster		Germany	48143
130	private practise Berger	Naunhof		Germany	4683
131	private practise Klopsch	Neubrandenburg		Germany	17033
132	Rheumazentrum SH Mitte GbR	Neumünster		Germany	24534
133	private practise Scholz	Neustadt-Glewe		Germany	19306
134	private practise Kloos	Neuwied		Germany	56564
135	Private Practise Hein	Nienburg		Germany	31582
136	Private Practise Vogel	Nürnberg		Germany	90482
137	private practise Albert	Offenburg		Germany	77652
138	private practise Voglau	Oldenburg		Germany	26123
139	private practise Gräßler	Pirna		Germany	1796
140	private practise Welcker	Planegg		Germany	82152
141	private practise Baumann	Plauen		Germany	8523
142	Private Practise Petersen	Potsdam		Germany	14469
143	Rheumahaus Potsdam GbR	Potsdam		Germany	14469
144	Knappschaftskrankenhaus Püttlingen	Püttlingen		Germany	66346
145	private practise Wassenberg	Ratingen		Germany	40882
146	private practise Schwokowski	Ratzeburg		Germany	23909
147	private practise Rumpel	Regensburg		Germany	93051
148	private practise Schumann	Reken		Germany	48734
149	Private Practise Walter	Rendburg		Germany	24768
150	Private Practise Kotterik	Reutlingen		Germany	72764
151	Private Practise Hoene	Rostock		Germany	18059
152	private practise Richter	Rostock		Germany	18059
153	private practise Lankow	Rostock		Germany	18069
154	private practise Biewer	Saarbrücken		Germany	66111
155	Private Practise Mobius	Schwerin		Germany	19053
156	private practise Möbius	Schwerin		Germany	19053
157	private practise Ständer	Schwerin		Germany	19053
158	private practise Melzer	Seesen		Germany	38723
159	Company for Medical Study&Service Selters	Selters/Ww		Germany	56242
160	Private Practise Hoese	Stadthagen		Germany	31655
161	private practise Steinborn	Straubing		Germany	94315
162	private practise Engel	Stuttgart		Germany	70178
163	ZIRS - Zentrum für Interdisziplinäre Rheumatologie Stuttgart	Stuttgart		Germany	70372
164	Private Practice Fahr	Suhl		Germany	98529
165	private practise Pyra	Torgelow		Germany	17358
166	MVZ der Johanniter	Treuenbrietzen		Germany	14929
167	Praxis Dr. Haas	Tübingen		Germany	72072
168	Private Practice Jacki	Tübingen		Germany	72072
169	Universitätsklinikum Tübingen	Tübingen		Germany	72076
170	Berufsausübungsgemeinschaft Dr. med Petra Roll und Dr. Margarete Kratzsch	Ulm / Donau		Germany	89073
171	private practise Rinaldi	Ulm / Donau		Germany	89073
172	Praxis Dres. Winkler-Gyulay, Moeller	Unna		Germany	59423
173	private practise Otte	Wesel		Germany	46483
174	private practise Schuart	Wissen/ Luhe		Germany	21423
175	private practise Metz	Wittstock		Germany	16909
176	private practise Senger	Wunstorf		Germany	31515
177	Klinikverbund St. Antonius und St. Josef GmbH, Krankenhaus St. Josef	Wuppertal		Germany	42105
178	Private Practise Sprekeler	Zeven		Germany	27404
179	private practise Fricke-Wagner	Zwickau		Germany	8056
180	private practise Alliger	Zwiesel		Germany	94227

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jan 30, 2015

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:

NCT02486302

Other Study ID Numbers:

B1801385
ADEQUATE

First Posted:

Jul 1, 2015

Last Update Posted:

Jun 24, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Spondylitis

Arthritis

Arthritis, Rheumatoid

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Etanercept
Arm/Group Description	All participants with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), or plaque psoriasis (PsO) taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Period Title: Overall Study
STARTED	1534
Treated	1523
COMPLETED	858
NOT COMPLETED	676

Baseline Characteristics

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Overall Participants	1465
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.9 (14.5)
Sex: Female, Male (Count of Participants)
Female	901 61.5%
Male	564 38.5%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12
Description	Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/h]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale [VAS] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 <2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
Per-protocol (PP) set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	794
Count of Participants [Participants]	194 13.2%

2. Primary Outcome

Title	Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24
Description	DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	664
Count of Participants [Participants]	203 13.9%

3. Primary Outcome

Title	Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks
Description	DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Week 12 up to Week 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	147
Count of Participants [Participants]	58 4%

4. Primary Outcome

Title	Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks
Description	DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame	Week 24 up to Week 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	169
Count of Participants [Participants]	88 6%

5. Primary Outcome

Title	Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1
Description	PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Count of Participants [Participants]	5 0.3%

6. Primary Outcome

Title	Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12
Description	ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	200
Count of Participants [Participants]	38 2.6%

7. Primary Outcome

Title	Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12
Description	DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC <=1; 2) SJC =<1; 3) PASI <= 1 or body surface area (BSA) <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) <= 0.5(HAQ=3.16-[0.028* hannover functional questionnaire [FFbH]); 7) Tender enthesial points <= 1.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	240
Count of Participants [Participants]	92 6.3%

8. Primary Outcome

Title	Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24
Description	PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	59
Count of Participants [Participants]	11 0.8%

9. Primary Outcome

Title	Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24
Description	ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	152
Count of Participants [Participants]	28 1.9%

10. Primary Outcome

Title	Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24
Description	DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t<=1; 2) SJC =<1; 3) PASI <= 1 or BSA <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI <= 0.5(HAQ=3.16-[0.028*FFbH); 7) Tender enthesial points <= 1.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	209
Count of Participants [Participants]	106 7.2%

11. Secondary Outcome

Title	Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS)
Description
Time Frame	Baseline up to Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1465
Up to Week 12	89.5 6.1%
Up to Week 24	81.2 5.5%
Up to Week 36	75.6 5.2%
Up to Week 52	71.6 4.9%

12. Secondary Outcome

Title	Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set
Description
Time Frame	Baseline up to Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Up to Week 12	89.4 6.1%
Up to Week 24	81.1 5.5%
Up to Week 36	75.6 5.2%
Up to Week 52	71.6 4.9%

13. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Time Frame	Baseline up to Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1465
Up to Week 12	417 28.5%
Up to Week 24	567 38.7%
Up to Week 36	651 44.4%
Up to Week 52	699 47.7%

14. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
Time Frame	Baseline up to Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Up to Week 12	416 28.4%
Up to Week 24	564 38.5%
Up to Week 36	646 44.1%
Up to Week 52	694 47.4%

15. Secondary Outcome

Title	Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52
Description	DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 <= 2.6 were considered in remission.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1078
Week 12	278 19%
Week 24	305 20.8%
Week 36	263 18%
Week 52	271 18.5%

16. Secondary Outcome

Title	Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52
Description	Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Week 12	39.8 (24.9)
Week 24	35.5 (25.1)
Week 36	32.7 (23.8)
Week 52	30.5 (23.3)

17. Secondary Outcome

Title	Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52
Description	Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Week 12	40.9 (30.1)
Week 24	37.7 (29.5)
Week 36	36.1 (28.9)
Week 52	33.5 (27.8)

18. Secondary Outcome

Title	Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52
Description	Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Week 12	38.3 (26.9)
Week 24	34.9 (26.3)
Week 36	32.9 (25.6)
Week 52	31.1 (24.7)

19. Secondary Outcome

Title	Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52
Description	PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Week 12	32.5 (21.1)
Week 24	26.9 (20.5)
Week 36	23.8 (19.4)
Week 52	21.7 (18.9)

20. Secondary Outcome

Title	Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52
Description	The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Week 12	2.0 (1.6)
Week 24	1.8 (1.6)
Week 36	1.7 (1.5)
Week 52	1.6 (1.5)

21. Secondary Outcome

Title	Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
Description	The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	824
Week 12: PtGA versus (vs.) Fatigue	0.514
Week 12: PtGA vs. Pain	0.825
Week 12: PtGA vs. PHQ-2	0.450
Week 12: PtGA vs. PGA	0.603
Week 12: Fatigue vs. Pain	0.586
Week 12: Fatigue vs. PHQ-2	0.577
Week 12: Fatigue vs. PGA	0.370
Week 12: Pain vs. PHQ-2	0.529
Week 12: Pain vs. PGA	0.612
Week 12: PHQ-2 vs. PGA	0.376
Week 24: PtGA vs. Fatigue	0.588
Week 24: PtGA vs. Pain	0.859
Week 24: PtGA vs. PHQ-2	0.526
Week 24: PtGA vs. PGA	0.600
Week 24: Fatigue vs. Pain	0.621
Week 24: Fatigue vs. PHQ-2	0.591
Week 24: Fatigue vs. PGA	0.389
Week 24: Pain vs. PHQ-2	0.558
Week 24: Pain vs. PGA	0.556
Week 24: PHQ-2 vs. PGA	0.379
Week 36: PtGA vs. Fatigue	0.664
Week 36: PtGA vs. Pain	0.839
Week 36: PtGA vs. PHQ-2	0.513
Week 36: PtGA vs. PGA	0.609
Week 36: Fatigue vs. Pain	0.646
Week 36: Fatigue vs. PHQ-2	0.614
Week 36: Fatigue vs. PGA	0.463
Week 36: Pain vs. PHQ-2	0.532
Week 36: Pain vs. PGA	0.576
Week 36: PHQ-2 vs. PGA	0.367
Week 52: PtGA vs. Fatigue	0.666
Week 52: PtGA vs. Pain	0.861
Week 52: PtGA vs. PHQ-2	0.507
Week 52: PtGA vs. PGA	0.632
Week 52: Fatigue vs. Pain	0.649
Week 52: Fatigue vs. PHQ-2	0.574
Week 52: Fatigue vs. PGA	0.485
Week 52: Pain vs. PHQ-2	0.545
Week 52: Pain vs. PGA	0.641
Week 52: PHQ-2 vs. PGA	0.445

22. Secondary Outcome

Title	Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
Description	The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	305
Week 12:PtGA vs. Fatigue	0.582
Week 12: PtGA vs. Pain	0.899
Week 12: PtGA vs. PHQ-2	0.526
Week 12: PtGA vs. PGA	0.606
Week 12: Fatigue vs. Pain	0.547
Week 12: Fatigue vs. PHQ-2	0.487
Week 12: Fatigue vs. PGA	0.369
Week 12: Pain vs. PHQ-2	0.530
Week 12: Pain vs. PGA	0.617
Week 12: PHQ-2 vs. PGA	0.392
Week 24: PtGA vs. Fatigue	0.668
Week 24: PtGA vs. Pain	0.904
Week 24: PtGA vs. PHQ-2	0.495
Week 24: PtGA vs. PGA	0.495
Week 24: Fatigue vs. Pain	0.664
Week 24: Fatigue vs. PHQ-2	0.634
Week 24: Fatigue vs. PGA	0.445
Week 24: Pain vs. PHQ-2	0.492
Week 24: Pain vs. PGA	0.515
Week 24: PHQ-2 vs. PGA	0.449
Week 36: PtGA vs. Fatigue	0.720
Week 36: PtGA vs. Pain	0.914
Week 36: PtGA vs. PHQ-2	0.630
Week 36: PtGA vs. PGA	0.586
Week 36: Fatigue vs. Pain	0.728
Week 36: Fatigue vs. PHQ-2	0.691
Week 36: Fatigue vs. PGA	0.530
Week 36: Pain vs. PHQ-2	0.637
Week 36: Pain vs. PGA	0.591
Week 36: PHQ-2 vs. PGA	0.483
Week 52: PtGA vs. Fatigue	0.717
Week 52: PtGA vs. Pain	0.912
Week 52: PtGA vs. PHQ-2	0.586
Week 52: PtGA vs. PGA	0.548
Week 52: Fatigue vs. Pain	0.743
Week 52: Fatigue vs. PHQ-2	0.676
Week 52: Fatigue vs. PGA	0.457
Week 52: Pain vs. PHQ-2	0.629
Week 52: Pain vs. PGA	0.603
Week 52: PHQ-2 vs. PGA	0.420

23. Secondary Outcome

Title	Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
Description	The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	254
Week 12: PtGA vs. Fatigue	0.630
Week 12: PtGA vs. Pain	0.892
Week 12: PtGA vs. PHQ-2	0.609
Week 12: PtGA vs. PGA	0.509
Week 12: Fatigue vs. Pain	0.664
Week 12: Fatigue vs. PHQ-2	0.601
Week 12: Fatigue vs. PGA	0.324
Week 12: Pain vs. PHQ-2	0.628
Week 12: Pain vs. PGA	0.529
Week 12: PHQ-2 vs. PGA	0.381
Week 24: PtGA vs. Fatigue	0.656
Week 24: PtGA vs. Pain	0.881
Week 24: PtGA vs. PHQ-2	0.562
Week 24: PtGA vs. PGA	0.559
Week 24: Fatigue vs. Pain	0.674
Week 24: Fatigue vs. PHQ-2	0.620
Week 24: Fatigue vs. PGA	0.374
Week 24: Pain vs. PHQ-2	0.607
Week 24: Pain vs. PGA	0.630
Week 24: PHQ-2 vs. PGA	0.410
Week 36: PtGA vs. Fatigue	0.692
Week 36: PtGA vs. Pain	0.913
Week 36: PtGA vs. PHQ-2	0.645
Week 36: PtGA vs. PGA	0.513
Week 36: Fatigue vs. Pain	0.724
Week 36: Fatigue vs. PHQ-2	0.710
Week 36: Fatigue vs. PGA	0.423
Week 36: Pain vs. PHQ-2	0.658
Week 36: Pain vs. PGA	0.532
Week 36: PHQ-2 vs. PGA	0.357
Week 52: PtGA vs. Fatigue	0.753
Week 52: PtGA vs. Pain	0.908
Week 52: PtGA vs. PHQ-2	0.696
Week 52: PtGA vs. PGA	0.565
Week 52: Fatigue vs. Pain	0.760
Week 52: Fatigue vs. PHQ-2	0.726
Week 52: Fatigue vs. PGA	0.430
Week 52: Pain vs. PHQ-2	0.683
Week 52: Pain vs. PGA	0.581
Week 52: PHQ-2 vs. PGA	0.498

24. Secondary Outcome

Title	Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52
Description	The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Week 12: PtGA vs. Fatigue	0.350
Week 12: PtGA vs. Pain	0.606
Week 12: PtGA vs. PHQ-2	0.563
Week 12: PtGA vs. PGA	0.606
Week 12: Fatigue vs. Pain	0.679
Week 12: Fatigue vs. PHQ-2	0.681
Week 12: Fatigue vs. PGA	0.175
Week 12: Pain vs. PHQ-2	0.647
Week 12: Pain vs. PGA	0.384
Week 12: PHQ-2 vs. PGA	0.265
Week 24: PtGA vs. Fatigue	0.651
Week 24: PtGA vs. Pain	0.692
Week 24: PtGA vs. PHQ-2	0.485
Week 24: PtGA vs. PGA	0.713
Week 24: Fatigue vs. Pain	0.802
Week 24: Fatigue vs. PHQ-2	0.577
Week 24: Fatigue vs. PGA	0.377
Week 24: Pain vs. PHQ-2	0.466
Week 24: Pain vs. PGA	0.470
Week 24: PHQ-2 vs. PGA	0.219
Week 36: PtGA vs. Fatigue	0.627
Week 36: PtGA vs. Pain	0.687
Week 36: PtGA vs. PHQ-2	0.585
Week 36: PtGA vs. PGA	0.519
Week 36: Fatigue vs. Pain	0.744
Week 36: Fatigue vs. PHQ-2	0.812
Week 36: Fatigue vs. PGA	0.288
Week 36: Pain vs. PHQ-2	0.659
Week 36: Pain vs. PGA	0.411
Week 36: PHQ-2 vs. PGA	0.167
Week 52: PtGA vs. Fatigue	0.418
Week 52: PtGA vs. Pain	0.625
Week 52: PtGA vs. PHQ-2	0.464
Week 52: PtGA vs. PGA	0.753
Week 52: Fatigue vs. Pain	0.579
Week 52: Fatigue vs. PHQ-2	0.598
Week 52: Fatigue vs. PGA	0.278
Week 52: Pain vs. PHQ-2	0.404
Week 52: Pain vs. PGA	0.421
Week 52: PHQ-2 vs. PGA	0.208

25. Secondary Outcome

Title	Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
Description	FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	824
Week 12: FFbH vs. Morning stiffness	-0.439
Week 24: FFbH vs. Morning stiffness	-0.486
Week 36: FFbH vs. Morning stiffness	-0.520
Week 52: FFbH vs. Morning stiffness	-0.502

26. Secondary Outcome

Title	Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
Description	FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	254
Week 12: FFbH vs. Morning stiffness	-0.493
Week 24: FFbH vs. Morning stiffness	-0.640
Week 36: FFbH vs. Morning stiffness	-0.615
Week 52: FFbH vs. Morning stiffness	-0.560

27. Secondary Outcome

Title	Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52
Description	FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	305
Week 12: FFbH vs. Morning stiffness	-0.523
Week 24: FFbH vs. Morning stiffness	-0.523
Week 36: FFbH vs. Morning stiffness	-0.565
Week 52: FFbH vs. Morning stiffness	-0.600

28. Secondary Outcome

Title	Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events
Description	Percentage of participants who discontinued etanercept before completing the study, was reported.
Time Frame	Baseline up to Week 52

Outcome Measure Data

Analysis Population Description
Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1465
Due to lack of Efficacy	15.2 1%
Due to Adverse Events	8.5 0.6%

29. Secondary Outcome

Title	Number of Participants Who Switched to Other Therapy After Treatment Discontinuation
Description	Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.
Time Frame	Baseline up to Week 52

Outcome Measure Data

Analysis Population Description
Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. Overall number of participants analyzed signifies participants from treated set who discontinued treatment with Etanercept.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	410
Abatacept	15 1%
Adalimumab	53 3.6%
Apremilast	7 0.5%
Azathioprin	1 0.1%
Azathioprin, Leflunomid, Diclofenac	1 0.1%
Azathioprin, Prednisolon	1 0.1%
Baricitinib	3 0.2%
Biological NOS	5 0.3%
Certolizumab	26 1.8%
Etanercept Biosimilar	10 0.7%
Golimumab	6 0.4%
Hydroxychloroquin	1 0.1%
Leflunomid	4 0.3%
Methotrexate (MTX)	6 0.4%
MTX, Adalimumab	2 0.1%
MTX, Prednisolon	3 0.2%
MTX, Tocilizumab	1 0.1%
Prednisolon	13 0.9%
Prednisolon, Diclofenac	1 0.1%
Remsima (Infliximab-Biosimilar)	1 0.1%
Rituximab	12 0.8%
Roactemra	10 0.7%
Secukinumab	27 1.8%
Sulfasalazin	1 0.1%
Sulfasalazin, Leflunomid	1 0.1%
Tapentadol	2 0.1%
Tocilizumab	25 1.7%
Tofacitinib	2 0.1%
Ustekinumab	7 0.5%
Etoricoxib	1 0.1%
Ibuprofen	2 0.1%
Ibuprofen, Metamizol	1 0.1%
Ibuprofen, Prednisolon, Oxycodon, Pregabalin	1 0.1%
Inflectra (Infliximab Biosimilar)	1 0.1%
Infliximab	1 0.1%
NSAR	1 0.1%
Corticosteroid	1 0.1%
PUVA	1 0.1%
Unknown	5 0.3%
None	56 3.8%
Missing values	92 6.3%

30. Secondary Outcome

Title	Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52
Description	FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicated better daily activities.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, axSpA or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1383
Week 12	71.4 (22.2)
Week 24	72.2 (22.4)
Week 36	73.4 (22.3)
Week 52	73.7 (22.5)

31. Secondary Outcome

Title	Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52
Description	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	824
Week 12	12.7 (9.7)
Week 24	11.0 (9.4)
Week 36	10.1 (8.9)
Week 52	9.2 (9.1)

32. Secondary Outcome

Title	Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52
Description	The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	824
Week 12	14.3 (11.0)
Week 24	12.0 (11.3)
Week 36	11.1 (9.7)
Week 52	10.1 (10.2)

33. Secondary Outcome

Title	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52
Description	BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	305
Week 12	3.8 (2.3)
Week 24	3.5 (2.3)
Week 36	3.2 (2.1)
Week 52	3.3 (2.2)

34. Secondary Outcome

Title	Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52
Description	An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	559
Week 12	1.0 (1.8)
Week 24	0.6 (1.2)
Week 36	0.4 (1.1)
Week 52	0.3 (1.0)

35. Secondary Outcome

Title	Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52
Description	Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	305
Week 12	6.7 (10.7)
Week 24	6.6 (11.3)
Week 36	6.3 (11.2)
Week 52	6.0 (11.0)

36. Secondary Outcome

Title	Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52
Description	Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO, PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO, PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	324
Week 12	8.5 (12.8)
Week 24	5.9 (9.2)
Week 36	4.8 (7.1)
Week 52	5.4 (10.9)

37. Secondary Outcome

Title	Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52
Description	Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	254
Week 12	1.4 (2.1)
Week 24	0.7 (1.3)
Week 36	0.7 (1.4)
Week 52	0.6 (1.3)

38. Secondary Outcome

Title	Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
Description	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each sectionarea scoreweight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Time Frame	Baseline, Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Baseline	16.8 (10.1)
Change at Week 12	-9.6 (10.3)
Change at Week 24	-13.0 (10.6)
Change at Week 36	-14.4 (10.9)
Change at Week 52	-14.8 (11.0)

39. Secondary Outcome

Title	Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO)
Description	PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Median (Standard Deviation) [days]	100 (85.6)

40. Secondary Outcome

Title	Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO)
Description	PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified categories.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Week 12, Erythema	1.4 (0.7)
Week 12: Induration	1.2 (0.7)
Week 12: Desquamation	1.1 (0.7)
Week 24: Erythema	1.0 (0.7)
Week 24: Induration	0.9 (0.6)
Week 24: Desquamation	0.9 (0.7)
Week 36: Erythema	0.7 (0.6)
Week 36: Induration	0.6 (0.5)
Week 36: Desquamation	0.6 (0.5)
Week 52: Erythema	0.7 (0.7)
Week 52: Induration	0.5 (0.5)
Week 52: Desquamation	0.6 (0.6)

41. Secondary Outcome

Title	Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO)
Description	PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified categories.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Week 12, Head	0.4 (0.8)
Week 12: Trunk	1.6 (2.0)
Week 12: Upper extremities	1.4 (1.6)
Week 12: Lower extremities	3.5 (3.7)
Week 24: Head	0.2 (0.5)
Week 24: Trunk	0.6 (0.8)
Week 24: Upper extremities	0.9 (1.0)
Week 24: Lower extremities	2.3 (2.7)
Week 36: Head	0.2 (0.4)
Week 36: Trunk	0.5 (0.9)
Week 36: Upper extremities	0.5 (0.5)
Week 36: Lower extremities	1.5 (2.0)
Week 52: Head	0.1 (0.3)
Week 52: Trunk	0.5 (1.0)
Week 52: Upper extremities	0.5 (0.5)
Week 52: Lower extremities	1.4 (1.9)

42. Secondary Outcome

Title	Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
Description	The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI < 2; small effect at 2 <=DLQI <= 5; moderate effect at 6 <=DLQI <= 10; very large effect at 11<=DLQI <= 20; extremely large effect at 21 <= DLQI <= 30.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Week 12	8.3 (7.4)
Week 24	5.5 (5.8)
Week 36	4.8 (5.5)
Week 52	3.7 (4.6)

43. Secondary Outcome

Title	Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52
Description	Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus".
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Week 12	35.5 (30.9)
Week 24	22.4 (23.8)
Week 36	24.2 (26.6)
Week 52	14.8 (15.8)

44. Other Pre-specified Outcome

Title	Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52
Description	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. 'Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Week 12	19.7 (18.4)
Week 24	19.4 (18.8)
Week 36	18.4 (17.4)
Week 52	18.2 (17.6)

45. Other Pre-specified Outcome

Title	C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52
Description	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1453
Week 12	10.9 (33.9)
Week 24	10.9 (37.4)
Week 36	10.2 (31.4)
Week 52	9.7 (30.3)

46. Other Pre-specified Outcome

Title	Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52
Description	RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, axSpA or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1383
Week 12	310 21.2%
Week 24	259 17.7%
Week 36	208 14.2%
Week 52	173 11.8%

47. Other Pre-specified Outcome

Title	Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52
Description	To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.
Time Frame	Weeks 12, 24, 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, AxS or PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, or PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	1383
Week 12	236.2 (695.7)
Week 24	202.2 (615.6)
Week 36	178.6 (635.3)
Week 52	176.2 (714.4)

48. Other Pre-specified Outcome

Title	Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA)
Description	Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	305
Count of Participants [Participants]	223 15.2%

49. Other Pre-specified Outcome

Title	Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52
Description	ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
Time Frame	Weeks 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with axSpA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	305
Week 36	35 2.4%
Week 52	32 2.2%

50. Other Pre-specified Outcome

Title	Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52
Description	DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC <=1; 2) SJC =<1; 3) PASI <= 1 or body surface area (BSA) <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) <= 0.5(HAQ=3.16-[0.028* hannover functional questionnaire [FFbH]); 7) Tender enthesial points <= 1.
Time Frame	Weeks 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	254
Week 36	93 6.3%
Week 52	87 5.9%

51. Other Pre-specified Outcome

Title	Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of "Clear" or "Almost Clear" And DLQI Total Score of 0 or 1 at Weeks 36 and 52
Description	PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Time Frame	Weeks 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	70
Week 36	13 0.9%
Week 52	14 1%

52. Other Pre-specified Outcome

Title	Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52
Description	DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 <= 2.6 were considered in remission.
Time Frame	Weeks 36, 52

Outcome Measure Data

Analysis Population Description
PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. "Number analyzed" signifies participants analyzed for this outcome measure at specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
Measure Participants	824
Week 36	173 11.8%
Week 52	187 12.8%

Adverse Events

	Etanercept
Time Frame	Baseline up to Week 52
Adverse Event Reporting Description	Same event may appear as both an AE & a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant & as non-serious in another participant, or one participant may have experienced both a serious & non-serious event during study. Treated set included all documented participants who were treated, had at least 1 post-baseline value & had an AE documented. All-cause mortality data included all anticipated & unanticipated deaths due to any cause.

Arm/Group Title	Etanercept
Arm/Group Description	All participants with RA, axSpA, PsA, or PsO taking etanercept in the routine treatment as per clinical practice and in line with summary of product characteristics clinical, were observed for a period of 12 months.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	5/1465 (0.3%)
Serious Adverse Events
	Etanercept
	Affected / at Risk (%)	# Events
Total	151/1465 (10.3%)
Blood and lymphatic system disorders
Leukopenia	1/1465 (0.1%)
Lymphadenitis	1/1465 (0.1%)
Lymphadenopathy	1/1465 (0.1%)
Thrombocytopenia	1/1465 (0.1%)
Cardiac disorders
Atrial fibrillation	4/1465 (0.3%)
Arrhythmia	3/1465 (0.2%)
Cardiac failure	2/1465 (0.1%)
Coronary artery disease	2/1465 (0.1%)
Myocardial infarction	2/1465 (0.1%)
Tachycardia	2/1465 (0.1%)
Acute myocardial infarction	1/1465 (0.1%)
Cardiovascular disorder	1/1465 (0.1%)
Pericardial effusion	1/1465 (0.1%)
Right ventricular failure	1/1465 (0.1%)
Ear and labyrinth disorders
Inner ear disorder	1/1465 (0.1%)
Vestibular disorder	1/1465 (0.1%)
Endocrine disorders
Goitre	1/1465 (0.1%)
Eye disorders
Diplopia	1/1465 (0.1%)
Visual impairment	1/1465 (0.1%)
Gastrointestinal disorders
Colitis ulcerative	2/1465 (0.1%)
Crohn's disease	2/1465 (0.1%)
Abdominal pain upper	1/1465 (0.1%)
Diverticulum intestinal	1/1465 (0.1%)
Large intestine perforation	1/1465 (0.1%)
Pancreatitis	1/1465 (0.1%)
Stomatitis	1/1465 (0.1%)
General disorders
Drug ineffective	5/1465 (0.3%)
Condition aggravated	16/1465 (1.1%)
Death	3/1465 (0.2%)
Injection site reaction	3/1465 (0.2%)
Pain	2/1465 (0.1%)
Disease progression	1/1465 (0.1%)
Disease recurrence	1/1465 (0.1%)
Drug effect decreased	1/1465 (0.1%)
Injection site erythema	1/1465 (0.1%)
Injection site swelling	1/1465 (0.1%)
Injection site warmth	1/1465 (0.1%)
Oedema peripheral	1/1465 (0.1%)
Therapy non-responder	1/1465 (0.1%)
Hepatobiliary disorders
Cholelithiasis	2/1465 (0.1%)
Cholestasis	1/1465 (0.1%)
Drug-induced liver injury	1/1465 (0.1%)
Hepatic cirrhosis	1/1465 (0.1%)
Hepatitis toxic	1/1465 (0.1%)
Jaundice	1/1465 (0.1%)
Immune system disorders
Drug hypersensitivity	2/1465 (0.1%)
Infections and infestations
Bronchitis	4/1465 (0.3%)
Pneumonia	4/1465 (0.3%)
Diverticulitis	2/1465 (0.1%)
Tonsillitis	2/1465 (0.1%)
Urosepsis	2/1465 (0.1%)
Abscess limb	1/1465 (0.1%)
Appendicitis	1/1465 (0.1%)
Arthritis infective	1/1465 (0.1%)
Borrelia infection	1/1465 (0.1%)
Bronchitis bacterial	1/1465 (0.1%)
Bronchopulmonary aspergillosis	1/1465 (0.1%)
Cellulitis	1/1465 (0.1%)
Epididymitis	1/1465 (0.1%)
Escherichia infection	1/1465 (0.1%)
Febrile infection	1/1465 (0.1%)
Gangrene	1/1465 (0.1%)
Gastroenteritis	1/1465 (0.1%)
Hepatitis e	1/1465 (0.1%)
Herpes zoster	1/1465 (0.1%)
Influenza	1/1465 (0.1%)
Mycobacterial infection	1/1465 (0.1%)
Nasal abscess	1/1465 (0.1%)
Nasopharyngitis	1/1465 (0.1%)
Paronychia	1/1465 (0.1%)
Peritonsillar abscess	1/1465 (0.1%)
Post procedural pneumonia	1/1465 (0.1%)
Respiratory tract infection	1/1465 (0.1%)
Sepsis	1/1465 (0.1%)
Tracheobronchitis	1/1465 (0.1%)
Tuberculosis	1/1465 (0.1%)
Urinary tract infection	1/1465 (0.1%)
Injury, poisoning and procedural complications
Tendon rupture	3/1465 (0.2%)
Fall	2/1465 (0.1%)
Femur fracture	2/1465 (0.1%)
Meniscus injury	2/1465 (0.1%)
Ankle fracture	1/1465 (0.1%)
Craniocerebral injury	1/1465 (0.1%)
Facial bones fracture	1/1465 (0.1%)
Fibula fracture	1/1465 (0.1%)
Humerus fracture	1/1465 (0.1%)
Ligament rupture	1/1465 (0.1%)
Maternal exposure during pregnancy	1/1465 (0.1%)
Pelvic fracture	1/1465 (0.1%)
Post procedural haematoma	1/1465 (0.1%)
Road traffic accident	1/1465 (0.1%)
Spinal fracture	1/1465 (0.1%)
Thoracic vertebral fracture	1/1465 (0.1%)
Tibia fracture	1/1465 (0.1%)
Tracheal deviation	1/1465 (0.1%)
Upper limb fracture	1/1465 (0.1%)
Wound dehiscence	1/1465 (0.1%)
Wrist fracture	1/1465 (0.1%)
Investigations
Hepatic enzyme increased	1/1465 (0.1%)
Renal function test abnormal	1/1465 (0.1%)
Troponin increased	1/1465 (0.1%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus	2/1465 (0.1%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	11/1465 (0.8%)
Intervertebral disc protrusion	5/1465 (0.3%)
Arthritis	3/1465 (0.2%)
Joint swelling	3/1465 (0.2%)
Rheumatoid arthritis	3/1465 (0.2%)
Arthralgia	2/1465 (0.1%)
Foot deformity	2/1465 (0.1%)
Pain in extremity	2/1465 (0.1%)
Rheumatic disorder	2/1465 (0.1%)
Spinal column stenosis	2/1465 (0.1%)
Ankylosing spondylitis	1/1465 (0.1%)
Facet joint syndrome	1/1465 (0.1%)
Fibromyalgia	1/1465 (0.1%)
Joint destruction	1/1465 (0.1%)
Joint effusion	1/1465 (0.1%)
Meniscal degeneration	1/1465 (0.1%)
Metatarsalgia	1/1465 (0.1%)
Musculoskeletal stiffness	1/1465 (0.1%)
Osteoporosis	1/1465 (0.1%)
Psoriatic arthropathy	1/1465 (0.1%)
Spondylitis	1/1465 (0.1%)
Synovial cyst	1/1465 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm	1/1465 (0.1%)
Prostate cancer	1/1465 (0.1%)
Small cell lung cancer	1/1465 (0.1%)
Nervous system disorders
Cerebrovascular accident	2/1465 (0.1%)
Axonal neuropathy	1/1465 (0.1%)
Facial paresis	1/1465 (0.1%)
Migraine	1/1465 (0.1%)
Sciatica	1/1465 (0.1%)
Pregnancy, puerperium and perinatal conditions
Abortion	1/1465 (0.1%)
Foetal growth restriction	1/1465 (0.1%)
Psychiatric disorders
Restlessness	1/1465 (0.1%)
Renal and urinary disorders
Nephritis	1/1465 (0.1%)
Nephrolithiasis	1/1465 (0.1%)
Ureteric stenosis	1/1465 (0.1%)
Reproductive system and breast disorders
Breast pain	1/1465 (0.1%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/1465 (0.1%)
Pleural effusion	2/1465 (0.1%)
Pulmonary embolism	2/1465 (0.1%)
Asthma	1/1465 (0.1%)
Lung disorder	1/1465 (0.1%)
Lung infiltration	1/1465 (0.1%)
Nasal septum haematoma	1/1465 (0.1%)
Pneumothorax	1/1465 (0.1%)
Skin and subcutaneous tissue disorders
Psoriasis	3/1465 (0.2%)
Acne	1/1465 (0.1%)
Alopecia	1/1465 (0.1%)
Rash generalised	1/1465 (0.1%)
Rash maculo-papular	1/1465 (0.1%)
Skin disorder	1/1465 (0.1%)
Urticaria	1/1465 (0.1%)
Surgical and medical procedures
Implantation of medial unicondylar sliding prosthesis knee left	1/1465 (0.1%)
Vascular disorders
Aortic stenosis	1/1465 (0.1%)
Circulatory collapse	1/1465 (0.1%)
Haematoma	1/1465 (0.1%)
Hypertensive crisis	1/1465 (0.1%)
Peripheral arterial occlusive disease	1/1465 (0.1%)
Peripheral artery stenosis	1/1465 (0.1%)
Raynaud's phenomenon	1/1465 (0.1%)
Vasculitis	1/1465 (0.1%)
Venous thrombosis limb	1/1465 (0.1%)
Other (Not Including Serious) Adverse Events
	Etanercept
	Affected / at Risk (%)	# Events
Total	606/1465 (41.4%)
Blood and lymphatic system disorders
Thrombocytopenia	3/1465 (0.2%)
Increased tendency to bruise	2/1465 (0.1%)
Leukopenia	2/1465 (0.1%)
Granulocytopenia	1/1465 (0.1%)
Immune thrombocytopenic purpura	1/1465 (0.1%)
Pancytopenia	1/1465 (0.1%)
Cardiac disorders
Angina pectoris	2/1465 (0.1%)
Arrhythmia	2/1465 (0.1%)
Palpitations	2/1465 (0.1%)
Extrasystoles	1/1465 (0.1%)
Tachyarrhythmia	1/1465 (0.1%)
Ear and labyrinth disorders
Deafness	1/1465 (0.1%)
Vertigo	1/1465 (0.1%)
Tinnitus	1/1465 (0.1%)
Eye disorders
Iritis	4/1465 (0.3%)
Visual impairment	2/1465 (0.1%)
Eye swelling	1/1465 (0.1%)
Glaucoma	1/1465 (0.1%)
Uveitis	1/1465 (0.1%)
Vision blurred	1/1465 (0.1%)
Cataract	1/1465 (0.1%)
Gastrointestinal disorders
Diarrhoea	12/1465 (0.8%)
Nausea	12/1465 (0.8%)
Abdominal discomfort	3/1465 (0.2%)
Abdominal pain	3/1465 (0.2%)
Constipation	2/1465 (0.1%)
Dry mouth	2/1465 (0.1%)
Gastrointestinal disorder	2/1465 (0.1%)
Stomatitis	2/1465 (0.1%)
Vomiting	2/1465 (0.1%)
Abdominal pain upper	1/1465 (0.1%)
Dyspepsia	1/1465 (0.1%)
Dysphagia	1/1465 (0.1%)
Flatulence	1/1465 (0.1%)
Gastric ulcer	1/1465 (0.1%)
Gastrointestinal inflammation	1/1465 (0.1%)
Gastrointestinal sounds abnormal	1/1465 (0.1%)
Irritable bowel syndrome	1/1465 (0.1%)
Loose tooth	1/1465 (0.1%)
Mouth ulceration	1/1465 (0.1%)
Steatorrhoea	1/1465 (0.1%)
Tongue discomfort	1/1465 (0.1%)
Tooth disorder	1/1465 (0.1%)
General disorders
Drug ineffective	203/1465 (13.9%)
Condition aggravated	35/1465 (2.4%)
Injection site erythema	34/1465 (2.3%)
Injection site reaction	22/1465 (1.5%)
Fatigue	13/1465 (0.9%)
Injection site pruritus	12/1465 (0.8%)
Pyrexia	10/1465 (0.7%)
Drug effect decreased	9/1465 (0.6%)
Pain	8/1465 (0.5%)
Injection site hypersensitivity	7/1465 (0.5%)
Oedema peripheral	7/1465 (0.5%)
Injection site pain	6/1465 (0.4%)
Injection site swelling	6/1465 (0.4%)
Drug effect incomplete	5/1465 (0.3%)
Injection site induration	3/1465 (0.2%)
Chest discomfort	2/1465 (0.1%)
Chest pain	2/1465 (0.1%)
Chills	2/1465 (0.1%)
Disease progression	2/1465 (0.1%)
Injection site rash	2/1465 (0.1%)
Local reaction	2/1465 (0.1%)
Swelling	2/1465 (0.1%)
Treatment failure	2/1465 (0.1%)
Adverse event	1/1465 (0.1%)
Asthenia	1/1465 (0.1%)
Discomfort	1/1465 (0.1%)
Disease recurrence	1/1465 (0.1%)
Drug intolerance	1/1465 (0.1%)
Face oedema	1/1465 (0.1%)
Gait disturbance	1/1465 (0.1%)
Hyperthermia	1/1465 (0.1%)
Inflammation	1/1465 (0.1%)
Influenza like illness	1/1465 (0.1%)
Injection site discharge	1/1465 (0.1%)
Injection site discolouration	1/1465 (0.1%)
Injection site inflammation	1/1465 (0.1%)
Injection site irritation	1/1465 (0.1%)
Malaise	1/1465 (0.1%)
Mucosal dryness	1/1465 (0.1%)
Oedema	1/1465 (0.1%)
Sensation of foreign body	1/1465 (0.1%)
Immune system disorders
Hypersensitivity	5/1465 (0.3%)
Anaphylactic reaction	2/1465 (0.1%)
Infections and infestations
Nasopharyngitis	62/1465 (4.2%)
Bronchitis	20/1465 (1.4%)
Respiratory tract infection	16/1465 (1.1%)
Upper respiratory tract infection	11/1465 (0.8%)
Infection	10/1465 (0.7%)
Herpes zoster	8/1465 (0.5%)
Sinusitis	8/1465 (0.5%)
Cystitis	7/1465 (0.5%)
Pulpitis dental	5/1465 (0.3%)
Tonsillitis	5/1465 (0.3%)
Pneumonia	4/1465 (0.3%)
Gastrointestinal infection	3/1465 (0.2%)
Rhinitis	3/1465 (0.2%)
Urinary tract infection	3/1465 (0.2%)
Conjunctivitis	2/1465 (0.1%)
Erysipelas	2/1465 (0.1%)
Fungal infection	2/1465 (0.1%)
Fungal skin infection	2/1465 (0.1%)
Paronychia	2/1465 (0.1%)
Rash pustular	2/1465 (0.1%)
Sinobronchitis	2/1465 (0.1%)
Skin candida	2/1465 (0.1%)
Subcutaneous abscess	2/1465 (0.1%)
Bacterial infection	1/1465 (0.1%)
Cellulitis	1/1465 (0.1%)
Diabetic foot infection	1/1465 (0.1%)
Escherichia urinary tract infection	1/1465 (0.1%)
Febrile infection	1/1465 (0.1%)
Furuncle	1/1465 (0.1%)
Gastroenteritis	1/1465 (0.1%)
Groin abscess	1/1465 (0.1%)
Hepatitis e	1/1465 (0.1%)
Herpes simplex	1/1465 (0.1%)
Influenza	1/1465 (0.1%)
Laryngitis	1/1465 (0.1%)
Localised infection	1/1465 (0.1%)
Oral herpes	1/1465 (0.1%)
Papilloma viral infection	1/1465 (0.1%)
Parotitis	1/1465 (0.1%)
Pharyngitis	1/1465 (0.1%)
Superinfection bacterial	1/1465 (0.1%)
Tooth infection	1/1465 (0.1%)
Tracheobronchitis	1/1465 (0.1%)
Urinary tract infection enterococcal	1/1465 (0.1%)
Viral infection	1/1465 (0.1%)
Vulvovaginal candidiasis	1/1465 (0.1%)
Infected bite	1/1465 (0.1%)
Injury, poisoning and procedural complications
Maternal exposure during pregnancy	5/1465 (0.3%)
Ligament sprain	3/1465 (0.2%)
Wound	3/1465 (0.2%)
Contusion	1/1465 (0.1%)
Epicondylitis	1/1465 (0.1%)
Fall	1/1465 (0.1%)
Humerus fracture	1/1465 (0.1%)
Inflammation of wound	1/1465 (0.1%)
Ligament injury	1/1465 (0.1%)
Maternal exposure before pregnancy	1/1465 (0.1%)
Muscle rupture	1/1465 (0.1%)
Post procedural complication	1/1465 (0.1%)
Procedural pain	1/1465 (0.1%)
Rib fracture	1/1465 (0.1%)
Spinal compression fracture	1/1465 (0.1%)
Tendon rupture	1/1465 (0.1%)
Investigations
Alanine aminotransferase increased	3/1465 (0.2%)
Gamma-glutamyltransferase increased	3/1465 (0.2%)
Aspartate aminotransferase increased	2/1465 (0.1%)
Liver function test increased	2/1465 (0.1%)
Transaminases increased	2/1465 (0.1%)
Blood creatinine increased	1/1465 (0.1%)
Blood thyroid stimulating hormone abnormal	1/1465 (0.1%)
C-reactive protein increased	1/1465 (0.1%)
Heart rate increased	1/1465 (0.1%)
Hepatic enzyme increased	1/1465 (0.1%)
Intraocular pressure increased	1/1465 (0.1%)
Renal function test abnormal	1/1465 (0.1%)
Weight decreased	1/1465 (0.1%)
Metabolism and nutrition disorders
Vitamin d deficiency	4/1465 (0.3%)
Gout	3/1465 (0.2%)
Hypercholesterolaemia	1/1465 (0.1%)
Hyperuricaemia	1/1465 (0.1%)
Metabolic syndrome	1/1465 (0.1%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis	23/1465 (1.6%)
Arthralgia	9/1465 (0.6%)
Joint swelling	5/1465 (0.3%)
Bursitis	4/1465 (0.3%)
Intervertebral disc protrusion	4/1465 (0.3%)
Joint effusion	3/1465 (0.2%)
Limb discomfort	3/1465 (0.2%)
Osteoarthritis	3/1465 (0.2%)
Pain in extremity	3/1465 (0.2%)
Rotator cuff syndrome	3/1465 (0.2%)
Synovitis	3/1465 (0.2%)
Arthritis	2/1465 (0.1%)
Back pain	2/1465 (0.1%)
Enthesopathy	2/1465 (0.1%)
Fibromyalgia	2/1465 (0.1%)
Osteitis	2/1465 (0.1%)
Spinal column stenosis	2/1465 (0.1%)
Tendon disorder	2/1465 (0.1%)
Arthropathy	1/1465 (0.1%)
Cervical spinal stenosis	1/1465 (0.1%)
Dactylitis	1/1465 (0.1%)
Intervertebral disc space narrowing	1/1465 (0.1%)
Mastication disorder	1/1465 (0.1%)
Muscular weakness	1/1465 (0.1%)
Musculoskeletal pain	1/1465 (0.1%)
Musculoskeletal stiffness	1/1465 (0.1%)
Myalgia	1/1465 (0.1%)
Neck pain	1/1465 (0.1%)
Osteoporosis	1/1465 (0.1%)
Psoriatic arthropathy	1/1465 (0.1%)
Rheumatic disorder	1/1465 (0.1%)
Rheumatoid nodule	1/1465 (0.1%)
Sacroiliitis	1/1465 (0.1%)
Sjogren's syndrome	1/1465 (0.1%)
Soft tissue disorder	1/1465 (0.1%)
Spinal osteoarthritis	1/1465 (0.1%)
Spinal pain	1/1465 (0.1%)
Spondylitis	1/1465 (0.1%)
Tenosynovitis	1/1465 (0.1%)
Trigger finger	1/1465 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/1465 (0.1%)
Haemangioma of liver	1/1465 (0.1%)
Melanocytic naevus	1/1465 (0.1%)
Nervous system disorders
Headache	10/1465 (0.7%)
Dizziness	4/1465 (0.3%)
Carpal tunnel syndrome	3/1465 (0.2%)
Burning sensation	2/1465 (0.1%)
Head discomfort	2/1465 (0.1%)
Paraesthesia	2/1465 (0.1%)
Balance disorder	1/1465 (0.1%)
Cerebrovascular disorder	1/1465 (0.1%)
Complex regional pain syndrome	1/1465 (0.1%)
Coordination abnormal	1/1465 (0.1%)
Cubital tunnel syndrome	1/1465 (0.1%)
Intercostal neuralgia	1/1465 (0.1%)
Memory impairment	1/1465 (0.1%)
Movement disorder	1/1465 (0.1%)
Spinal cord disorder	1/1465 (0.1%)
Trigeminal neuralgia	1/1465 (0.1%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/1465 (0.1%)
Oligohydramnios	1/1465 (0.1%)
Psychiatric disorders
Depression	8/1465 (0.5%)
Sleep disorder	2/1465 (0.1%)
Aggression	1/1465 (0.1%)
Apathy	1/1465 (0.1%)
Panic attack	1/1465 (0.1%)
Somatic symptom disorder	1/1465 (0.1%)
Renal and urinary disorders
Haematuria	2/1465 (0.1%)
Bladder disorder	1/1465 (0.1%)
Chronic kidney disease	1/1465 (0.1%)
Cystitis noninfective	1/1465 (0.1%)
Dysuria	1/1465 (0.1%)
Leukocyturia	1/1465 (0.1%)
Renal colic	1/1465 (0.1%)
Renal failure	1/1465 (0.1%)
Reproductive system and breast disorders
Uterine haematoma	1/1465 (0.1%)
Respiratory, thoracic and mediastinal disorders
Cough	9/1465 (0.6%)
Dyspnoea	5/1465 (0.3%)
Oropharyngeal pain	4/1465 (0.3%)
Bronchitis chronic	1/1465 (0.1%)
Epistaxis	1/1465 (0.1%)
Haemoptysis	1/1465 (0.1%)
Laryngeal inflammation	1/1465 (0.1%)
Pharyngeal oedema	1/1465 (0.1%)
Pleurisy	1/1465 (0.1%)
Rhinorrhoea	1/1465 (0.1%)
Snoring	1/1465 (0.1%)
Vocal cord inflammation	1/1465 (0.1%)
Skin and subcutaneous tissue disorders
Pruritus	16/1465 (1.1%)
Erythema	12/1465 (0.8%)
Rash	12/1465 (0.8%)
Hyperhidrosis	6/1465 (0.4%)
Alopecia	5/1465 (0.3%)
Psoriasis	5/1465 (0.3%)
Dermatitis allergic	4/1465 (0.3%)
Skin disorder	4/1465 (0.3%)
Skin reaction	4/1465 (0.3%)
Urticaria	4/1465 (0.3%)
Pustular psoriasis	3/1465 (0.2%)
Skin irritation	3/1465 (0.2%)
Dermatitis	2/1465 (0.1%)
Pruritus generalised	2/1465 (0.1%)
Skin ulcer	2/1465 (0.1%)
Dermatitis exfoliative generalised	1/1465 (0.1%)
Dermatosis	1/1465 (0.1%)
Dry skin	1/1465 (0.1%)
Eczema	1/1465 (0.1%)
Generalised erythema	1/1465 (0.1%)
Hidradenitis	1/1465 (0.1%)
Papule	1/1465 (0.1%)
Rash erythematous	1/1465 (0.1%)
Rash macular	1/1465 (0.1%)
Rash papular	1/1465 (0.1%)
Rosacea	1/1465 (0.1%)
Seborrhoeic dermatitis	1/1465 (0.1%)
Skin burning sensation	1/1465 (0.1%)
Skin discolouration	1/1465 (0.1%)
Skin erosion	1/1465 (0.1%)
Stasis dermatitis	1/1465 (0.1%)
Swelling face	1/1465 (0.1%)
Vascular skin disorder	1/1465 (0.1%)
Xanthelasma	1/1465 (0.1%)
Vascular disorders
Peripheral venous disease	1/1465 (0.1%)

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:

NCT02486302

Other Study ID Numbers:

B1801385
ADEQUATE

First Posted:

Jul 1, 2015

Last Update Posted:

Jun 24, 2019

Last Verified:

Mar 1, 2019

ADEQUATE: A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

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Adverse Events

All Cause Mortality