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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00395577 |
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Date of registration:
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01/11/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
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Scientific title:
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A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00395577 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Bulgaria
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Croatia
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Former Serbia and Montenegro
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Poland
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Russian Federation
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Slovenia
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Contacts
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Name:
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Robert Kauffman, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vertex Pharmaceuticals Incorporated |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: VX-702
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Primary Outcome(s)
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To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
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Secondary Outcome(s)
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To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone
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Secondary ID(s)
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VX06-702-304
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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