N/A
N=1,534
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.
Rheumatoid Arthritis · Psoriatic Arthritis · Axial Spondyloarthritis · Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02486302 ↗Enrolled (actual)
1,534
Serious AEs
10.3%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 — 194 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Etanercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 |
194 | — |
| PRIMARY Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 |
203 | — |
| PRIMARY 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 |
58 | — |
| PRIMARY 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 |
88 | — |
| PRIMARY 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 |
5 | — |
| PRIMARY Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 |
38 | — |
| PRIMARY 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 |
92 | — |
| PRIMARY 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 |
11 | — |
| PRIMARY Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 |
28 | — |
| PRIMARY 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 |
106 | — |
| SECONDARY Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) |
89.5; 81.2; 75.6; 71.6 | — |
| SECONDARY Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set |
89.4; 81.1; 75.6; 71.6 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set |
417; 567; 651; 699 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set |
416; 564; 646; 694 | — |
| SECONDARY Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 |
278; 305; 263; 271 | — |
| SECONDARY Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 |
39.8; 35.5; 32.7; 30.5 | — |
| SECONDARY Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 |
40.9; 37.7; 36.1; 33.5 | — |
| SECONDARY Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 |
38.3; 34.9; 32.9; 31.1 | — |
| SECONDARY Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 |
32.5; 26.9; 23.8; 21.7 | — |
| SECONDARY Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 |
2.0; 1.8; 1.7; 1.6 | — |
| SECONDARY 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 |
0.514; 0.825; 0.450; 0.603; 0.586; 0.577 | — |
| SECONDARY 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 |
0.582; 0.899; 0.526; 0.606; 0.547; 0.487 | — |
| SECONDARY 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 |
0.630; 0.892; 0.609; 0.509; 0.664; 0.601 | — |
| SECONDARY 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 |
0.350; 0.606; 0.563; 0.606; 0.679; 0.681 | — |
| SECONDARY Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 |
-0.439; -0.486; -0.520; -0.502 | — |
| SECONDARY Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 |
-0.493; -0.640; -0.615; -0.560 | — |
| SECONDARY Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 |
-0.523; -0.523; -0.565; -0.600 | — |
| SECONDARY Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events |
15.2; 8.5 | — |
| SECONDARY Number of Participants Who Switched to Other Therapy After Treatment Discontinuation |
15; 53; 7; 1; 1; 1 | — |
| SECONDARY 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 |
71.4; 72.2; 73.4; 73.7 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 |
12.7; 11.0; 10.1; 9.2 | — |
| SECONDARY Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 |
14.3; 12.0; 11.1; 10.1 | — |
| SECONDARY Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 |
3.8; 3.5; 3.2; 3.3 | — |
| SECONDARY Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 |
1.0; 0.6; 0.4; 0.3 | — |
| SECONDARY Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 |
6.7; 6.6; 6.3; 6.0 | — |
| SECONDARY 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 |
8.5; 5.9; 4.8; 5.4 | — |
| SECONDARY Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 |
1.4; 0.7; 0.7; 0.6 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 |
16.8; -9.6; -13.0; -14.4; -14.8 | — |
| SECONDARY Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) |
100 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) |
1.4; 1.2; 1.1; 1.0; 0.9; 0.9 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) |
0.4; 1.6; 1.4; 3.5; 0.2; 0.6 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 |
8.3; 5.5; 4.8; 3.7 | — |
| SECONDARY Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 |
35.5; 22.4; 24.2; 14.8 | — |
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,
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02486302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.