Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

December 5, 2007 updated by: Vertex Pharmaceuticals Incorporated

A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to assess the clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

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
      • Sofia, Bulgaria
        • Medical University - Sofia
      • Sofia, Bulgaria
        • Military Medical Academy - Sofia
      • Sofia, Bulgaria
        • Transport Hospital
      • Stara Zagora, Bulgaria
        • MBAL "Stara Zagora" EAD
  • Croatia
      • Opatija, Croatia
        • Thalassotherapia
      • Osijek, Croatia
        • KBC Osijek Ambulanta za bol
      • Zagreb, Croatia
        • University Hospital Centre Zagreb
  • Czech Republic
      • Brno, Czech Republic
        • University Hospital U Sv.Anny
      • Praha 10, Czech Republic
        • University Hospital Kralovske Vinohrady
      • Praha 11, Czech Republic
        • SZZ-Jizni Mesto II
      • Praha 2, Czech Republic
        • Institute of Rheumatology
      • Praha 6, Czech Republic
        • Rheumatology Out-patient Department
  • Former Serbia and Montenegro
      • Beograd, Former Serbia and Montenegro
        • Institute of Rheumatology
      • Niska Banja, Former Serbia and Montenegro
        • Institute of Rheumatology - Niska Banja
      • Zemun, Former Serbia and Montenegro
        • Clinical Center Zemun
  • Poland
      • Bytom, Poland
        • Szpital Specjalistyczny Nr 1
      • Elblag, Poland
        • Wojewodzki Szpital Zespolony
      • Krakow, Poland
        • Malopolskie Centrum Medyczne
      • Lublin, Poland
        • "Gabinety Profesorow" Prywatna Praktyka
      • Lublin, Poland
        • Instytut Medycyny Wsi im. Witolda Chodzki
      • Sopot, Poland
        • Wojewodzki Zespoￅﾂ Reumatologiczny im.
      • Torun, Poland
        • NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy
      • Wroclaw, Poland
        • Okregowy Szpital Kolejowy
      • Zyrardow, Poland
        • ZOZ Zyrardow
  • Russian Federation
      • Moscow, Russian Federation
        • Pirogov City Clinical Hospital #1
      • Moscow, Russian Federation
        • State Institute of Rheumatology of RAMS
      • Novosibirsk, Russian Federation
        • State Clinical Immunology Research
      • Ryazan, Russian Federation
        • Ryazan Regional Clinical Cardiologic
      • Saint Petersburg, Russian Federation
        • Saint Petersburg Clinical Hospital
      • Saint-Petersburg, Russian Federation
        • Saint-Petersburg City Hospital
      • Saint-Petersburg, Russian Federation
        • Saint-Petersburg Medical Academy
      • Saratov, Russian Federation
        • Saratov regional clinical hospital
      • St. Petersburg, Russian Federation
        • City Pokrovskaya Hospital
      • St. Petersburg, Russian Federation
        • EVIDENCE Clinical and Pharmaceutical Research
      • St. Petersburg, Russian Federation
        • Leningrad Regional Hospital
  • Slovakia
      • Piestany, Slovakia
        • National Institute of Rheumatic Diseases
  • Slovenia
      • Ljubljana, Slovenia
        • Clinical Center Ljubljana
  • Ukraine
      • Dniepropetrovsk, Ukraine
        • Dniepropetrovsk State Medical Academy
      • Donetsk, Ukraine
        • Donetsk State Medical University
      • Kiev, Ukraine
        • Institute of Cardiology of Ukranian AMS
      • Kiev, Ukraine
        • Institute of Gerontology of Ukrainian AMS
      • Kiev, Ukraine
        • SanaClis s.r.o.
      • Zaporizhya, Ukraine
        • Zaporizhya Medical Institute

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:

  • Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.

Exclusion Criteria:

  • Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.

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
The primary endpoint for the study is the ACR20 response at Week 12.

Secondary Outcome Measures

Outcome Measure
The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.

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

June 1, 2005

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

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

  • VX04-702-301

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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