CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 542 enrolled
Drug / intervention
Etanercept +2 moredrug
Likely dose
Etanercept 50 mg SC injections weekly + oral Methotrexate weeklyAI-extracted
Key inclusion· 2
  • ✓Satisfies 1987 ACR Revised Criteria for Rheumatoid Arthritis
  • ✓RA duration ≥3 months and ≤2 years
Key exclusion· 2
  • ✕Prior methotrexate treatment
  • ✕Prior etanercept or other TNF antagonist

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00195494
NCT00195494Phase 4Completed
CompareCT.gov

A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Sep 19, 2005·Updated Sep 5, 2012

In Brief

A Phase 4 clinical trial evaluating Etanercept, Methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 542 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartNov 1, 2004
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

Etanerceptdrug

Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 \& 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2

Methotrexatedrug

Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 \& 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2 Group 2b: Oral Methotrexate weekly for both Periods 1 and 2

Placebodrug

Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2