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. (ADEQUATE)

• ClinicalTrials.gov Identifier: NCT02486302
• Recruitment Status: Completed
• First Posted: July 1, 2015
• Results First Posted: June 24, 2019
• Last Update Posted: June 24, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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
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: March 24, 2015
• Actual Primary Completion Date: December 11, 2017
• Actual Study Completion Date: December 11, 2017

Groups and Cohorts

Group/Cohort	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 :

1. Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 [ Time Frame: 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.
2. Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 [ Time Frame: 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.
3. 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 [ Time Frame: 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.
4. 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 [ Time Frame: 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.
5. 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 [ Time Frame: 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).
6. Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 [ Time Frame: 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.
7. 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 [ Time Frame: 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.
8. 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 [ Time Frame: 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).
9. Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 [ Time Frame: 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.
10. 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 [ Time Frame: 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 :

1. Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) [ Time Frame: Baseline up to Weeks 12, 24, 36, 52 ]
2. Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set [ Time Frame: Baseline up to Weeks 12, 24, 36, 52 ]
3. Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set [ Time Frame: 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.
4. Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set [ Time Frame: 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.
5. Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
6. Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
7. Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
8. Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 [ Time Frame: 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).
9. Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
10. Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 [ Time Frame: 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).
11. 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 [ Time Frame: 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.
12. 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 [ Time Frame: 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.
13. 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 [ Time Frame: 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.
14. 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 [ Time Frame: 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.
15. Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [ Time Frame: 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).
16. Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [ Time Frame: 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).
17. Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [ Time Frame: 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).
18. Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants who discontinued etanercept before completing the study, was reported.
19. Number of Participants Who Switched to Other Therapy After Treatment Discontinuation [ Time Frame: Baseline up to Week 52 ]
    Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.
20. 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 [ Time Frame: 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.
21. Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
22. Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
23. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 [ Time Frame: 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).
24. Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
25. Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
26. 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 [ Time Frame: 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.
27. Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
28. Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
29. Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) [ Time Frame: 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.
30. Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) [ Time Frame: 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).
31. Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) [ Time Frame: 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).
32. Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
33. Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [ Time Frame: 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:

1. Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
2. C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
3. Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 [ Time Frame: 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.
4. Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
   To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.
5. Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) [ Time Frame: Baseline ]
   Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.
6. Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 [ Time Frame: 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.
7. 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 [ Time Frame: 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.
8. 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 [ Time Frame: 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).
9. Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory and Hospital care patients treated for Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriasis Arthritis or Plaque Psoriasis in Germany

Criteria

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

Germany

Rheumatologisches MVZ Dresden GmbH im Gesundheitszentrum Dresden - Klotzsche (GZDK)

Dresden, Sachsen, Germany, 01109

private practise Hemmerich

Aachen, Germany, 52062

private practise Kurthen

Aachen, Germany, 52064

Gesundheits- und Pflegezentrum Alsfeld gGmbH

Alsfeld, Germany, 36304

private practise Kupka

Altenburg, Germany, 4600

Private Practise Boehm

Altenholz, Germany, 24161

Private Practise Marycz

Amberg, Germany, 92224

Klinikum Bad Bramstedt

Bad Bramstedt, Germany, 24576

private practise Gause

Bad Bramstedt, Germany, 24576

private practise Messis

Bad Homburg, Germany, 61348

ACURA Rheumazentrum Bad Kreuznach

Bad Kreuznach, Germany, 55543

private practise Hesse

Bad Kreuznach, Germany, 55543

private practise Manger

Bamberg, Germany, 96047

private practise Balzer

Bautzen, Germany, 2625

private practise Winkler

Bautzen, Germany, 2625

private practise Ochs

Bayreuth, Germany, 95444

private practise Schmitt-Haendle

Bayreuth, Germany, 95444

Charité Berlin Rheumatologie und Klinische Immunologie

Berlin, Germany, 10117

Med. Versorgungszentrum Ambulantes Gesundheitszentrum Charite Campus Mitte

Berlin, Germany, 10117

private practise Hasert

Berlin, Germany, 10117

Praxis Roßbacher

Berlin, Germany, 10247

private practise Bozorg

Berlin, Germany, 10713

private practise Brandt-Jürgens

Berlin, Germany, 12161

private practise Herzberg

Berlin, Germany, 12435

private practise Remstedt

Berlin, Germany, 12435

private practise Seifert

Berlin, Germany, 12555

private practise Zinke

Berlin, Germany, 13055

private practise Kors

Berlin, Germany, 13086

Rheumaklinik Berlin-Buch

Berlin, Germany, 13125

private practise Miehe

Berlin, Germany, 13507

private practise Schnorfeil

Berlin, Germany, 14163

private practise Koelnberger

Bogen, Germany, 94327

private practise Barth

Borna, Germany, 4552

private practise Eisterhues

Braunschweig, Germany, 38100

Private Practise Ramaker-Brunke

Braunschweig, Germany, 38114

private practise Mall

Bremen, Germany, 28195

private practise Schwichtenberg

Bremen, Germany, 28779

Private Practise Wagener

Bruchhausen-Vilsen, Germany, 27305

private practise Feuchtenberger

Burghausen, Germany, 84489

private practise Budde

Bückeburg, Germany, 31675

Mvz Agliomed

Chemnitz, Germany, 09130

private practise Schneider

Chemnitz, Germany, 9116

private practise Geißler

Cottbus, Germany, 3046

private practise Kirrstetter

Deggendorf, Germany, 94469

Kreiskrankenhaus Demmin GmbH

Demmin, Germany, 17109

private practise Heidlas

Dessau, Germany, 6842

private practise Bebnowski

Dortmund, Germany, 44309

private practise Gerlach

Dresden, Germany, 1097

private practise Lüthke

Dresden, Germany, 1097

private practise Fischer

Dresden, Germany, 1277

private practise Oppers

Dresden, Germany, 1277

private practise Roch

Dresden, Germany, 1277

private practise Fendler

Duisburg, Germany, 47057

private practise Riesopp

Duisburg, Germany, 47249

private practise Strothmeyer

Düsseldorf, Germany, 40211

Bezirksklinikum Obermain

Ebensfeld, Germany, 96250

private practise Berendt

Eberswalde, Germany, 16225

private practise Pech

Eberswalde, Germany, 16225

Asklepios MVZ Nord SH GmbH, c/o AK St. Georg

Elmshorn, Germany, 25335

Elbe Elster MVZ GmbH

Elsterwerda, Germany, 49110

MVZ Kaestner + Kaestner GbR

Erfurt, Germany, 99096

private practise Koch

Erfurt, Germany, 99096

Universitaetsklinikum Essen, Klinik fuer Dermatologie

Essen, Germany, 45147

private practise Freitag

Falkensee, Germany, 14612

private practise Häckel

Frankenberg, Germany, 9669

Klinikum der J.W. Goethe-Universität, Klinik für Dermatologie, Klinische Forschung

Frankfurt/Main, Germany, 60590

private practise Fritzsch

Frankfurt, Germany, 15230

private practise Höhne

Fraureuth, Germany, 8427

private practise Müller

Freiberg, Germany, 9588

private practise Behringer

Fulda, Germany, 36093

private practise Bussmann

Geilenkirchen, Germany, 52511

private practise Zeh

Geislingen A.d. Steige, Germany, 73312

Private Practice Abahji

Germering, Germany, 82110

Private Practise

Giessen, Germany, 35392

Praxis Dres. Dr.Brinkmann, Schult, Samimi-Fard

Gladbeck, Germany, 45964

private practise Kühne

Haldensleben, Germany, 39340

private practise Liebhaber

Halle, Germany, 6128

MVZ Rheumatologie und Autoimmunmedizin GmbH

Hamburg, Germany, 20095

MVZ Nord GmbH

Hamburg, Germany, 21073

Katholisches Marienkrankenhaus Geriatrische Klinik

Hamburg, Germany, 22087

Private Practise Höhle

Hamburg, Germany, 22147

private practise Dahmen

Hamburg, Germany, 22415

private practise Weinhardt

Hamburg, Germany, 22523

private practise Aries

Hamburg, Germany, 22767

Praxis Praxis Dr. Szabo & Kollegen

Hamm, Germany, 59065

Private Practise Stille

Hannover, Germany, 30161

private practise Stein

Hannover, Germany, 30167

private practise Heilig

Heidelberg, Germany, 69120

private practise Lassak-Siedl

Heidelberg, Germany, 69120

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

private Practise Pawlak

Heilbad Heiligenstadt, Germany, 37308

private practise Schleußner

Heilbad Heiligenstadt, Germany, 37308

private practise Thies

Herrsching, Germany, 82211

private practise Meier

Hofheim, Germany, 65719

private practise Wernicke

Hohen Neuendorf, Germany, 16540

Private Practice Streibl

Holzkirchen, Germany, 83607

private practise Kapelle

Hoyerswerda, Germany, 2977

Uniklinik Jena

Jena, Germany, 7747

Private Practise Kremers

Jülich, Germany, 52428

private practise Bräunig

Kahla, Germany, 7768

Praxis Mauer

Kamenz, Germany, 1917

Private Practise Turin

Karlstadt, Germany, 97753

private practise Schwab

Kiel, Germany, 24105

Office of Parysa Alborz, MD

Koeln, Germany, 50937

private practise Straub

Kronach, Germany, 96317

private practise Wilden

Köln, Germany, 50825

private practise Merkel

Königs Wusterhausen, Germany, 15711

Kreiskrankenhaus Langenau

Langenau, Germany, 89129

Boche-Hamann-Teich

Leipzig, Germany, 4109

private practise Schwarze

Leipzig, Germany, 4129

private practise Zeiger

Leipzig, Germany, 4275

private practise Wiemers

Leipzig, Germany, 4317

private practise Weiß

Lichtenstein, Germany, 9350

private practise Holst

Ludwigslust, Germany, 19288

Private Practise Legler

Luebeck, Germany, 23564

private practise Kudela

Magdeburg, Germany, 39104

private practise Raschke

Magdeburg, Germany, 39104

private practise Sieburg

Magdeburg, Germany, 39104

private practise Weimann

Magdeburg, Germany, 39110

Hautklinik der Universitätsmedizin Mainz KöR,Clinical Research Center

Mainz, Germany, 55101

private practise Zimmermann

Malchow, Germany, 17213

Praxis Roßbach

Mansfeld OT Großörner, Germany, 06343

private practise Harmuth

Marktredwitz, Germany, 95615

Private Practise Bödekker

Marl, Germany, 45768

private practise Reck

Mittelherwigsdorf, Germany, 2763

private practise Vollmer

Monchengladbach, Germany, 41061

Stadt Klinikum Muenchen

Munchen, Germany, 81925

private practise Krüger

München, Germany, 81541

private practise Raub

Münster, Germany, 48143

private practise Berger

Naunhof, Germany, 4683

private practise Klopsch

Neubrandenburg, Germany, 17033

Rheumazentrum SH Mitte GbR

Neumünster, Germany, 24534

private practise Scholz

Neustadt-Glewe, Germany, 19306

private practise Kloos

Neuwied, Germany, 56564

Private Practise Hein

Nienburg, Germany, 31582

Private Practise Vogel

Nürnberg, Germany, 90482

private practise Albert

Offenburg, Germany, 77652

private practise Voglau

Oldenburg, Germany, 26123

private practise Gräßler

Pirna, Germany, 1796

private practise Welcker

Planegg, Germany, 82152

private practise Baumann

Plauen, Germany, 8523

Private Practise Petersen

Potsdam, Germany, 14469

Rheumahaus Potsdam GbR

Potsdam, Germany, 14469

Knappschaftskrankenhaus Püttlingen

Püttlingen, Germany, 66346

private practise Wassenberg

Ratingen, Germany, 40882

private practise Schwokowski

Ratzeburg, Germany, 23909

private practise Rumpel

Regensburg, Germany, 93051

private practise Schumann

Reken, Germany, 48734

Private Practise Walter

Rendburg, Germany, 24768

Private Practise Kotterik

Reutlingen, Germany, 72764

Private Practise Hoene

Rostock, Germany, 18059

private practise Richter

Rostock, Germany, 18059

private practise Lankow

Rostock, Germany, 18069

private practise Biewer

Saarbrücken, Germany, 66111

Private Practise Mobius

Schwerin, Germany, 19053

private practise Möbius

Schwerin, Germany, 19053

private practise Ständer

Schwerin, Germany, 19053

private practise Melzer

Seesen, Germany, 38723

Company for Medical Study&Service Selters

Selters/Ww, Germany, 56242

Private Practise Hoese

Stadthagen, Germany, 31655

private practise Steinborn

Straubing, Germany, 94315

private practise Engel

Stuttgart, Germany, 70178

ZIRS - Zentrum für Interdisziplinäre Rheumatologie Stuttgart

Stuttgart, Germany, 70372

Private Practice Fahr

Suhl, Germany, 98529

private practise Pyra

Torgelow, Germany, 17358

MVZ der Johanniter

Treuenbrietzen, Germany, 14929

Praxis Dr. Haas

Tübingen, Germany, 72072

Private Practice Jacki

Tübingen, Germany, 72072

Universitätsklinikum Tübingen

Tübingen, Germany, 72076

Berufsausübungsgemeinschaft Dr. med Petra Roll und Dr. Margarete Kratzsch

Ulm / Donau, Germany, 89073

private practise Rinaldi

Ulm / Donau, Germany, 89073

Praxis Dres. Winkler-Gyulay, Moeller

Unna, Germany, 59423

private practise Otte

Wesel, Germany, 46483

private practise Schuart

Wissen/ Luhe, Germany, 21423

private practise Metz

Wittstock, Germany, 16909

private practise Senger

Wunstorf, Germany, 31515

Klinikverbund St. Antonius und St. Josef GmbH, Krankenhaus St. Josef

Wuppertal, Germany, 42105

Private Practise Sprekeler

Zeven, Germany, 27404

private practise Fricke-Wagner

Zwickau, Germany, 8056

private practise Alliger

Zwiesel, Germany, 94227

Sponsors and Collaborators

Pfizer

Investigators

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

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol and Statistical Analysis Plan  [PDF] January 30, 2015

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Feist E, Baraliakos X, Behrens F, Thaci D, Klopsch T, Plenske A, Blindzellner LK, Klaus P, Meng T, Loschmann PA. Effectiveness of Etanercept in Rheumatoid Arthritis: Real-World Data from the German Non-interventional Study ADEQUATE with Focus on Treat-to-Target and Patient-Reported Outcomes. Rheumatol Ther. 2022 Apr;9(2):621-635. doi: 10.1007/s40744-021-00418-5. Epub 2022 Feb 3.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02486302
• Other Study ID Numbers: B1801385; ADEQUATE ( Other Identifier: Alias Study Number )
• First Posted: July 1, 2015
• Results First Posted: June 24, 2019
• Last Update Posted: June 24, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Additional relevant MeSH terms:

Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Psoriasis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthropathies; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Infections; Etanercept; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents