A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis

Vertex Pharmaceuticals Incorporated63 sites in 11 countries300 target enrollmentStarted: June 2005Last updated: December 7, 2007

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: Vertex Pharmaceuticals Incorporated
Enrollment: 300
Locations: 63
Primary Endpoint: The primary endpoint for the study is the ACR20 response at Week 12.

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The purpose of this study is to assess the clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 18 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.

Exclusion Criteria

•Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.

Outcomes

Primary Outcomes

The primary endpoint for the study is the ACR20 response at Week 12.

Secondary Outcomes

The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.

Investigators

Sponsor

Vertex Pharmaceuticals Incorporated

Sponsor Class

Industry

Study Sites (63)

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