Phase 4
Completed N=300
Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
Source: ClinicalTrials.gov NCT00422227 ↗Enrolled (actual)
300
Serious AEs
3.0%
Results posted
Aug 2010
Primary outcomePrimary: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks — 434.83; 289.54 Units on a scale — p=<0.001
Summary
The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks |
434.83; 289.54 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving ACR 20, 50, and 70 Responses |
78.87; 58.16; 56.70; 34.69; 19.07; 7.14 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission) |
39.09; 18.45; 15.74; 7.77 | <0.001 sig |
| SECONDARY Percent Change From Baseline in DAS28 at Week 16 |
38.32; 27.46 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response |
87.82; 73.79 | 0.003 sig |
| SECONDARY Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2 |
91.37; 78.64; 82.74; 66.02 | 0.003 sig |
| SECONDARY Percent Change From Baseline in Painful and Swollen Joint Counts |
34.17; 27.68; 46.11; 36.71; 55.48; 49.71 | 0.014 sig |
| SECONDARY Percent Change From Baseline in Physician And Subject Global Assessments |
30.40; 11.83; 39.58; 22.81; 45.86; 35.41 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Duration (Minutes) of Morning Stiffness |
54.92; 16.43; 63.85; 33.22; 73.41; 37.35 | <0.001 sig |
| SECONDARY Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales |
21.14; 8.88; 30.61; 22.78; 38.57; 27.86 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of RA
- Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
- Active RA at time of screening and baseline
Exclusion Criteria
- Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
- Concurrent treatment with a DMARD, other than MTX, at screening
- Receipt of any DMARD, other than MTX, within 3 months before screening
Data sourced from ClinicalTrials.gov (NCT00422227). 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. Informational only — not medical advice.