NCT01185353

A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants with Rheumatoid Arthritis (RA).

Detailed description

This study consists of the following: * Screening period: 4 to 28-days * Part A: a 12-week blinded, placebo controlled treatment period * Part B: a 12-week blinded extension period * Part C: an optional 52-week open-label extension period * Part D: an additional optional 52-week open-label extension period * Follow up period: 28 days

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	LY3009104	Administered orally
DRUG	Placebo	Administered orally
DRUG	Methotrexate	Administered orally as background therapy

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2014-03-01
• First posted: 2010-08-19
• Last updated: 2017-06-16
• Results posted: 2017-04-21

Locations

68 sites across 9 countries: United States, Croatia, Czechia, Hungary, India, Mexico, Poland, Romania, Ukraine