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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395577
• Other study ID #: VX06-702-304
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2006
• Last updated: December 5, 2007
• Start date: November 2006
• Est. completion date: July 2007

Study information

• Verified date: December 2007
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia and Montenegro: Agency for Drugs and Medicinal DevicesPoland: Ministry of HealthSlovenia: Ministry of HealthCroatia: Ministry of Health and Social CareBulgaria: Bulgarian Drug AgencyRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• VX-702

Locations

Country	Name	City	State
Bulgaria	Call For Information	Dimitrovgrad
Bulgaria	Call For Information	Pleven
Bulgaria	Call For Information	Sofia
Bulgaria	Call For Information	Veliko Tarnovo
Croatia	Call For Information	Osijek
Croatia	Call For Information	Zagreb
Former Serbia and Montenegro	Call For Information	Belgrade
Former Serbia and Montenegro	Call For Information	Niska Banja
Former Serbia and Montenegro	Call For Information	Zemun
Poland	Call For Information	Bytom
Poland	Call For Information	Krakow
Poland	Call for Information	Torun
Poland	Call For Information	Zyrardow
Russian Federation	Call For Information	Novosibirsk
Russian Federation	Call For Information	Saratov
Russian Federation	Call For Information	St. Petersburg
Slovenia	Call For Information	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Former Serbia and Montenegro,  Poland,  Russian Federation,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
Secondary	To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone