CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 371 enrolled
Drug / intervention
etanercept pre-filled syringe subcutaneous injection +4 moredrug
Likely dose
Oral methotrexate 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02373813
NCT02373813Phase 3Completed
CompareCT.gov

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis

Amgen·interventional·Posted Feb 27, 2015·Updated Jan 11, 2023

In Brief

A Phase 3 clinical trial evaluating etanercept pre-filled syringe subcutaneous injection, Oral methotrexate, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 371 participants across 136 sites in 15 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy. This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Mexico, Poland, Portugal, South Africa, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 27, 2015
Enrollment StartFeb 20, 2015
Primary CompletionDec 6, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.3 years ago

Interventions

etanercept pre-filled syringe subcutaneous injectiondrug

etanercept for injection in pre-filled syringes

Oral methotrexatedrug

During the open-label run-in period, methotrexate will be provided as 2.5 mg tablets. During the double-blind treatment period, methotrexate will be provided as 2.5 mg capsules.

Placebo for etanercept subcutaneous injectiondrug

etanercept placebo for injection in pre-filled syringes

Placebo for methotrexatedrug

methotrexate placebo capsules

Folic acid (non-investigational product)dietary

Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.