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

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

This study has been completed.

Sponsored by:	Vertex Pharmaceuticals Incorporated
Information provided by:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00205478

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: VX-702	Phase II

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

VX 702

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	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

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	300
Study Start Date:	June 2005
Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205478

Show 43 Study Locations

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Investigators


Study Director:	Robert Kauffman, MD, PhD	Vertex Pharmaceuticals Incorporated

More Information

Study ID Numbers:	VX04-702-301
First Received:	September 12, 2005
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00205478
Health Authority:	Poland: Ministry of Health; Czech Republic: State Institute for Drug Control; Slovakia: State Institute for Drug Control; Slovenia: Agency for Medicinal Products - Ministry of Health; Croatia: Ministry of Health and Social Care; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Bulgaria: Bulgarian Drug Agency; Russia: Pharmacological Committee, Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health

Study placed in the following topic categories:

Autoimmune Diseases

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2008