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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:
ClinicalTrials.gov Identifier:
NCT00395577
First Posted: November 3, 2006
Last Update Posted: December 7, 2007
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.
Information provided by:
Vertex Pharmaceuticals Incorporated
  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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00395577


Locations
Bulgaria
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Dimitrovgrad, Bulgaria
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Pleven, Bulgaria
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Sofia, Bulgaria
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Veliko Tarnovo, Bulgaria
Croatia
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Osijek, Croatia
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Zagreb, Croatia
Former Serbia and Montenegro
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Belgrade, Former Serbia and Montenegro
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Niska Banja, Former Serbia and Montenegro
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Zemun, Former Serbia and Montenegro
Poland
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Bytom, Poland
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Krakow, Poland
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Torun, Poland
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Zyrardow, Poland
Russian Federation
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Novosibirsk, Russian Federation
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Saratov, Russian Federation
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St. Petersburg, Russian Federation
Slovenia
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Ljubljana, Slovenia
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: NCT00395577     History of Changes
Other Study ID Numbers: VX06-702-304
First Submitted: November 1, 2006
First Posted: November 3, 2006
Last Update Posted: December 7, 2007
Last Verified: December 2007

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