CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 588 enrolled
Drug / intervention
Baricitinib +4 moredrug
Likely dose
Not stated in 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/NCT01711359
NCT01711359Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs

Eli Lilly and Company·interventional·Posted Oct 22, 2012·Updated Sep 19, 2019

In Brief

A Phase 3 clinical trial evaluating Baricitinib, Methotrexate, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 588 participants across 154 sites in 19 countries.

Detailed Summary

The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Austria, Belgium, Brazil, Canada, Germany, Greece, India, Italy, Japan, Mexico, Portugal, Puerto Rico, Russia, South Africa, South Korea, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2012
Enrollment StartNov 1, 2012
Primary CompletionFeb 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.7 years ago

Interventions

Baricitinibdrug

Administered orally

Methotrexatedrug

Administered orally

Baricitinib Placebodrug

Baricitinib placebo administered orally once daily.

MTX Placebodrug

MTX placebo administered orally once weekly.

Folic Aciddrug

Administered orally every day