CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 527 enrolled
Drug / intervention
Placebo +2 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/NCT01721044
NCT01721044Phase 3Completed

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

Eli Lilly and Company·interventional·Posted Nov 2, 2012·Updated Sep 18, 2019

In Brief

A Phase 3 clinical trial evaluating Placebo, Baricitinib, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 527 participants across 103 sites in 22 countries.

Detailed Summary

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2012
Enrollment StartJan 1, 2013
Primary CompletionJun 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.7 years ago

Interventions

Placebodrug

Administered orally

Baricitinibdrug

Administered orally

cDMARDdrug

Participants will continue to take background cDMARD therapy throughout study.