CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 684 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/NCT01721057
NCT01721057Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis

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 684 participants across 147 sites in 23 countries.

Detailed Summary

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR \[inadequate response\] participants) and who have not received a biologic disease-modifying antirheumatic drug (DMARD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Belgium, Canada, Croatia, Czechia, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2012
Enrollment StartDec 1, 2012
Primary CompletionSep 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.7 years ago

Interventions

Placebodrug

Administered orally

Baricitinibdrug

Administered orally

cDMARDdrug

Conventional disease-modifying anti-rheumatic drug as a background therapy