A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate
1 other identifier
interventional
120
6 countries
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Nov 2006
Shorter than P25 for phase_2 rheumatoid-arthritis
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedFirst Posted
Study publicly available on registry
November 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 7, 2007
December 1, 2007
November 1, 2006
December 5, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
Secondary Outcomes (1)
To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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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
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Bytom, Poland
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Krakow, Poland
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Torun, Poland
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Żyrardów, Poland
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Novosibirsk, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Belgrade, Serbia and Montenegro
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Niska Banja, Serbia and Montenegro
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Zemun, Serbia and Montenegro
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Ljubljana, Slovenia
Related Publications (1)
Damjanov N, Kauffman RS, Spencer-Green GT. Efficacy, pharmacodynamics, and safety of VX-702, a novel p38 MAPK inhibitor, in rheumatoid arthritis: results of two randomized, double-blind, placebo-controlled clinical studies. Arthritis Rheum. 2009 May;60(5):1232-41. doi: 10.1002/art.24485.
PMID: 19404957DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Kauffman, MD, PhD
Vertex Pharmaceuticals Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2006
First Posted
November 3, 2006
Study Start
November 1, 2006
Study Completion
July 1, 2007
Last Updated
December 7, 2007
Record last verified: 2007-12