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

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00205478
First received: September 12, 2005
Last updated: December 5, 2007
Last verified: December 2007
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Drug: VX-702 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

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

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

Estimated Enrollment: 300
Study Start Date: June 2005
Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205478

  Show 43 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Robert Kauffman, MD, PhD Vertex Pharmaceuticals Incorporated
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00205478     History of Changes
Other Study ID Numbers: VX04-702-301
Study First Received: September 12, 2005
Last Updated: December 5, 2007

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2017