Phase 4
Completed N=542
Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00195494 ↗Enrolled (actual)
542
Serious AEs
—
Results posted
Sep 2012
Primary outcomePrimary: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. — 73; 132 participants — p=<0.001
Summary
To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. |
73; 132 | <0.001 sig |
| PRIMARY Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. |
135; 196 | <0.001 sig |
| SECONDARY Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death |
0; 0; 0; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
- Has RA greater than or equal to 3 months and less than or equal to 2 years
Exclusion Criteria
- Received any previous treatment with MTX
- Received any previous treatment with ETN or other tumour necrosis factor antagonist
Data sourced from ClinicalTrials.gov (NCT00195494). 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.