Phase 3
Completed N=550
Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00445770 ↗
Enrolled (actual)
550
Serious AEs
5.3%
Results posted
Aug 2011
Primary outcomePrimary: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 — 9.82; 5.19; 3.33 Scores on a scale — p=<0.0001
Summary
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 |
9.82; 5.19; 3.33 | <0.0001 sig |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 |
5.11; 2.42; 1.74 | <0.0001 sig |
| SECONDARY Change From Baseline in Erosion Score at Weeks 24 and 52 |
2.90; 1.25; 1.12; 5.43; 2.75; 2.03 | <0.0001 sig |
| SECONDARY Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 |
2.21; 1.18; 0.62; 4.39; 2.44; 1.31 | <0.0001 sig |
| SECONDARY Percentage of Participants With no Progression of Joint Destruction at Week 52 |
25.7; 45.3; 49.2; 46.8; 64.2; 68.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
13.84; 14.23; 14.00; -3.39; -5.96; -5.02 | 0.0032 sig |
| SECONDARY Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
17.12; 16.30; 17.48; -3.41; -6.81; -7.73 | <0.0001 sig |
| SECONDARY Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
6.34; 6.23; 6.20; -1.23; -2.20; -2.25 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
6.01; 6.12; 5.95; -0.65; -1.81; -1.79 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
204.74; 203.80; 223.48; -46.39; -98.73; -108.37 | 0.0027 sig |
| SECONDARY Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
54.91; 54.37; 52.63; -5.98; -18.85; -18.67 | <0.0001 sig |
| SECONDARY Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
58.37; 58.71; 55.70; -8.06; -21.07; -20.27 | <0.0001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
1.01; 1.17; 1.06; -0.06; -0.30; -0.34 | <0.0001 sig |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response |
16.1; 54.0; 49.4; 27.3; 55.5; 56.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With an ACR50 Response |
2.3; 14.7; 16.0; 4.0; 28.1; 22.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With an ACR70 Response |
0; 4.2; 3.8; 0.6; 7.8; 8.2 | 0.0162 sig |
| SECONDARY Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
4.07; 4.03; 4.05; -0.48; -1.09; -1.05 | <0.0001 sig |
| SECONDARY Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
5.84; 5.75; 5.82; -0.52; -1.32; -1.38 | <0.0001 sig |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
21.13; 22.86; 22.09; -3.08; -13.41; -15.62 | <0.0001 sig |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
42.55; 42.00; 43.66; -1.86; -13.67; -16.91 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Must be Japanese and live in Japan
- Must be age 20 to 75 years
- Diagnosed less than or equal to 10 years from time of first visit
Exclusion Criteria
- Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab in the past
- Patient with other rheumatic diseases or conditions that could predispose the patient to infection
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT00445770). 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.