CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
Abatacept +3 moredrug
Likely dose
Abatacept 125 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/NCT01142726
NCT01142726Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA

Bristol-Myers Squibb·interventional·Posted Jun 11, 2010·Updated Jan 14, 2016

In Brief

A Phase 3 clinical trial evaluating Abatacept, Methotrexate, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 511 participants across 73 sites in 15 countries.

Detailed Summary

The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Mexico, Poland, Russia, South Africa, South Korea, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2010
Enrollment StartDec 1, 2010
Primary CompletionSep 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.1 years ago

Interventions

Abataceptdrug

Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months

Methotrexatedrug

Tablets, oral, 2.5 mg, once weekly, 12 months

Abatacept placebodrug

Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months

Methotrexate placebodrug

Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months