Clinical trial NCT00395577: A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
Official title: A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
Secondary outcomes:
measure: To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone
Other outcomes:
Locations:
city: Dimitrovgrad
country: Bulgaria
facility: Call For Information
city: Pleven
country: Bulgaria
facility: Call For Information
city: Sofia
country: Bulgaria
facility: Call For Information
city: Veliko Tarnovo
country: Bulgaria
facility: Call For Information
city: Osijek
country: Croatia
facility: Call For Information
city: Zagreb
country: Croatia
facility: Call For Information
city: Belgrade
country: Former Serbia and Montenegro
facility: Call For Information
city: Niska Banja
country: Former Serbia and Montenegro
facility: Call For Information
city: Zemun
country: Former Serbia and Montenegro
facility: Call For Information
city: Bytom
country: Poland
facility: Call For Information
city: Krakow
country: Poland
facility: Call For Information
city: Torun
country: Poland
facility: Call for Information
city: Zyrardow
country: Poland
facility: Call For Information
city: Novosibirsk
country: Russian Federation
facility: Call For Information
city: Saratov
country: Russian Federation
facility: Call For Information
city: St. Petersburg
country: Russian Federation
facility: Call For Information
city: Ljubljana
country: Slovenia
facility: Call For Information
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Robert Kauffman, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.