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

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Registration Number
NCT00395577
Lead Sponsor
Vertex Pharmaceuticals Incorporated
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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)
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
Secondary Outcome Measures
NameTimeMethod
To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone

Trial Locations

Locations (2)

Call For Information

🇸🇮

Ljubljana, Slovenia

Call for Information

🇵🇱

Torun, Poland

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