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

NCT ID: NCT00205478

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-02-28

Brief Summary

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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.

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

* 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.
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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Medical University - Sofia

Sofia, , Bulgaria

Site Status

Military Medical Academy - Sofia

Sofia, , Bulgaria

Site Status

Transport Hospital

Sofia, , Bulgaria

Site Status

MBAL "Stara Zagora" EAD

Stara Zagora, , Bulgaria

Site Status

Thalassotherapia

Opatija, , Croatia

Site Status

KBC Osijek Ambulanta za bol

Osijek, , Croatia

Site Status

University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

University Hospital U Sv.Anny

Brno, , Czechia

Site Status

Institute of Rheumatology

Prague, , Czechia

Site Status

Rheumatology Out-patient Department

Prague, , Czechia

Site Status

SZZ-Jizni Mesto II

Prague, , Czechia

Site Status

University Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status

Szpital Specjalistyczny Nr 1

Bytom, , Poland

Site Status

Wojewodzki Szpital Zespolony

Elblag, , Poland

Site Status

Malopolskie Centrum Medyczne

Krakow, , Poland

Site Status

"Gabinety Profesorow" Prywatna Praktyka

Lublin, , Poland

Site Status

Instytut Medycyny Wsi im. Witolda Chodzki

Lublin, , Poland

Site Status

Wojewodzki Zespoᅤツ Reumatologiczny im.

Sopot, , Poland

Site Status

NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy

Torun, , Poland

Site Status

Okregowy Szpital Kolejowy

Wroclaw, , Poland

Site Status

ZOZ Zyrardow

Żyrardów, , Poland

Site Status

Pirogov City Clinical Hospital #1

Moscow, , Russia

Site Status

State Institute of Rheumatology of RAMS

Moscow, , Russia

Site Status

State Clinical Immunology Research

Novosibirsk, , Russia

Site Status

Ryazan Regional Clinical Cardiologic

Ryazan, , Russia

Site Status

City Pokrovskaya Hospital

Saint Petersburg, , Russia

Site Status

EVIDENCE Clinical and Pharmaceutical Research

Saint Petersburg, , Russia

Site Status

Leningrad Regional Hospital

Saint Petersburg, , Russia

Site Status

Saint Petersburg Clinical Hospital

Saint Petersburg, , Russia

Site Status

Saint-Petersburg City Hospital

Saint Petersburg, , Russia

Site Status

Saint-Petersburg Medical Academy

Saint Petersburg, , Russia

Site Status

Saratov Regional Clinical Hospital

Saratov, , Russia

Site Status

Institute of Rheumatology

Beograd, , Serbia and Montenegro

Site Status

Institute of Rheumatology - Niska Banja

Niska Banja, , Serbia and Montenegro

Site Status

Clinical Center Zemun

Zemun, , Serbia and Montenegro

Site Status

National Institute of Rheumatic Diseases

Piešťany, , Slovakia

Site Status

Clinical Center Ljubljana

Ljubljana, , Slovenia

Site Status

Dniepropetrovsk State Medical Academy

Dniepropetrovsk, , Ukraine

Site Status

Donetsk State Medical University

Donetsk, , Ukraine

Site Status

Institute of Cardiology of Ukranian AMS

Kiev, , Ukraine

Site Status

Institute of Gerontology of Ukrainian AMS

Kiev, , Ukraine

Site Status

SanaClis s.r.o.

Kiev, , Ukraine

Site Status

Zaporizhya Medical Institute

Zaporizhya, , Ukraine

Site Status

Countries

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Bulgaria Croatia Czechia Poland Russia Serbia and Montenegro Slovakia Slovenia Ukraine

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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VX04-702-301

Identifier Type: -

Identifier Source: org_study_id