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

This study has been completed.

Sponsored by:	Vertex Pharmaceuticals Incorporated
Information provided by:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00395577

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 II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate VX 702

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395577

Locations

Bulgaria
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Sofia, Bulgaria
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Dimitrovgrad, Bulgaria
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Pleven, Bulgaria
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Veliko Tarnovo, Bulgaria
Croatia
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Zagreb, Croatia
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Osijek, Croatia
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Zagreb, Croatia
Poland
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Krakow, Poland
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Bytom, Poland
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Zyrardow, Poland
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Torun, Poland
Russian Federation
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St. Petersburg, Russian Federation
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Novosibirsk, Russian Federation
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Saratov, Russian Federation
Serbia and Montenegro
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Zemun, Serbia and Montenegro
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Niska Banja, Serbia and Montenegro
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Belgrade, Serbia and Montenegro
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

Study ID Numbers:	VX06-702-304
Study First Received:	November 1, 2006
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00395577
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

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009