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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
History of Changes
  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:

U.S. FDA Resources

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
Genders Eligible for Study:   Both
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
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

No publications provided by Vertex Pharmaceuticals Incorporated

Additional 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
Health Authority: Poland: Ministry of Health
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Croatia: Ministry of Health and Social Care
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Bulgaria: Bulgarian Drug Agency
Russia: Pharmacological Committee, Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

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 May 22, 2013