NCT00902486

INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	INCB028050	4 mg capsules QD
DRUG	INCB028050	7 mg capsules QD
DRUG	INCB028050	10 mg capsule QD
DRUG	Placebo	Placebo matching INCB028050 QD

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2009-05-15
• Last updated: 2018-09-04
• Results posted: 2018-09-04

Locations

49 sites across 2 countries: United States, Czechia