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A 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:
NCT00395577
First received: November 1, 2006
Last updated: December 5, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to assess the safety and effects of VX-702 in subjects with moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.


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 Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone

Estimated Enrollment: 120
Study Start Date: November 2006
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients 18 to 75 years of age with active RA
  • Must have been taking MTX for at least 6 months
  • No concurrent DMARD treatment (other than a stable dose of MTX)

Exclusion Criteria:

  • Planned major surgery (e.g., joint replacement) within the duration of the treatment period of the study
  • Treated with intra-articular injections of corticosteroids within 28 days prior to Day 1
  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: NCT00395577

Locations
Bulgaria
Call For Information
Dimitrovgrad, Bulgaria
Call For Information
Pleven, Bulgaria
Call For Information
Sofia, Bulgaria
Call For Information
Veliko Tarnovo, Bulgaria
Croatia
Call For Information
Osijek, Croatia
Call For Information
Zagreb, Croatia
Former Serbia and Montenegro
Call For Information
Belgrade, Former Serbia and Montenegro
Call For Information
Niska Banja, Former Serbia and Montenegro
Call For Information
Zemun, Former Serbia and Montenegro
Poland
Call For Information
Bytom, Poland
Call For Information
Krakow, Poland
Call for Information
Torun, Poland
Call For Information
Zyrardow, Poland
Russian Federation
Call For Information
Novosibirsk, Russian Federation
Call For Information
Saratov, Russian Federation
Call For Information
St. Petersburg, Russian Federation
Slovenia
Call For Information
Ljubljana, Slovenia
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: NCT00395577     History of Changes
Other Study ID Numbers: VX06-702-304
Study First Received: November 1, 2006
Last Updated: December 5, 2007
Health Authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Poland: Ministry of Health
Slovenia: Ministry of Health
Croatia: Ministry of Health and Social Care
Bulgaria: Bulgarian Drug Agency
Russia: Pharmacological Committee, Ministry of Health

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

ClinicalTrials.gov processed this record on November 20, 2014