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

NCT ID: NCT00395577

Last Updated: 2007-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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VX-702

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Principal Investigators

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Robert Kauffman, MD, PhD

Role: STUDY_DIRECTOR

Vertex Pharmaceuticals Incorporated

Locations

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Call For Information

Dimitrovgrad, , Bulgaria

Site Status

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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

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Countries

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Bulgaria Croatia Poland Russia Serbia and Montenegro Slovenia

References

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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.

Reference Type DERIVED
PMID: 19404957 (View on PubMed)

Other Identifiers

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VX06-702-304

Identifier Type: -

Identifier Source: org_study_id