CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 145 enrolled
Drug / intervention
Placebo +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/NCT01469013
NCT01469013Phase 2Completed
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A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy

Eli Lilly and Company·interventional·Posted Nov 10, 2011·Updated Sep 20, 2019

In Brief

A Phase 2 clinical trial evaluating Placebo, Baricitinib, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 145 participants across 14 sites.

Detailed Summary

This is a Phase 2b, outpatient, randomized, double-blinded (with a single-blind extension), placebo-controlled, dose-ranging, parallel-group study of baricitinib (LY3009104) in Japanese participants with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy. Baricitinib will be orally administered once a day with background methotrexate \[6 to 16 milligrams (mg)/week\] therapy for 12 weeks in the double-blind treatment period (1, 2, 4 or 8 mg/day, or placebo), and for 52 weeks in the single-blind extension period (4 or 8 mg/day).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartNov 1, 2011
Primary CompletionNov 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.6 years ago

Interventions

Placebodrug

Baricitinibdrug

Baricitinibdrug

Baricitinibdrug

Methotrexatedrug

Administered orally as background therapy