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A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

This study has been completed.
Information provided by:
Vertex Pharmaceuticals Incorporated Identifier:
First received: November 1, 2006
Last updated: December 5, 2007
Last verified: December 2007
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

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

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
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Please refer to this study by its identifier: NCT00395577

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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
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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
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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
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Ljubljana, Slovenia
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Study Director: Robert Kauffman, MD, PhD Vertex Pharmaceuticals Incorporated
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00395577     History of Changes
Other Study ID Numbers: VX06-702-304
Study First Received: November 1, 2006
Last Updated: December 5, 2007

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on August 23, 2017