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

December 5, 2007 updated by: Vertex Pharmaceuticals Incorporated

A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone

Secondary Outcome Measures

Outcome Measure
To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Investigators

  • Study Director: Robert Kauffman, MD, PhD, Vertex Pharmaceuticals Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 1, 2006

First Submitted That Met QC Criteria

November 1, 2006

First Posted (Estimate)

November 3, 2006

Study Record Updates

Last Update Posted (Estimate)

December 7, 2007

Last Update Submitted That Met QC Criteria

December 5, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX06-702-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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