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

Phase 2CompletedNCT00205478

Vertex Pharmaceuticals Incorporated300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Rheumatoid Arthritis

Interventions

VX-702DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (43)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Medical University - Sofia

Sofia, Bulgaria

Military Medical Academy - Sofia

Sofia, Bulgaria

Transport Hospital

Sofia, Bulgaria

MBAL "Stara Zagora" EAD

Stara Zagora, Bulgaria

Thalassotherapia

Opatija, Croatia

KBC Osijek Ambulanta za bol

Osijek, Croatia

University Hospital Centre Zagreb

Zagreb, Croatia

University Hospital U Sv.Anny

Brno, Czechia

Institute of Rheumatology

Prague, Czechia

Rheumatology Out-patient Department

Prague, Czechia

...and 33 more locations