NCT01469013

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	Baricitinib
DRUG	Baricitinib
DRUG	Baricitinib
DRUG	Methotrexate	Administered orally as background therapy

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-11-01
• Completion: 2013-12-01
• First posted: 2011-11-10
• Last updated: 2019-09-20
• Results posted: 2018-11-01

Locations

14 sites across 1 country: Japan