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Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00205478
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 7, 2007
Information provided by:
Vertex Pharmaceuticals Incorporated

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: VX-702 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The primary endpoint for the study is the ACR20 response at Week 12.

Secondary Outcome Measures :
  1. The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00205478

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Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
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Study Director: Robert Kauffman, MD, PhD Vertex Pharmaceuticals Incorporated

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00205478    
Other Study ID Numbers: VX04-702-301
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases