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Completed

NCT Number: NCT00395577

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Call For Information, Dimitrovgrad, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VX-702

Drug

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

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Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Nov 3, 2006
Registry last updated
Dec 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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