A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VX-702
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
Sites / Locations
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Outcomes
Primary Outcome Measures
To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
Secondary Outcome Measures
To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone
Full Information
NCT ID
NCT00395577
First Posted
November 1, 2006
Last Updated
December 5, 2007
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00395577
Brief Title
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
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VX-702
Primary Outcome Measure Information:
Title
To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
Secondary Outcome Measure Information:
Title
To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kauffman, MD, PhD
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Call For Information
City
Dimitrovgrad
Country
Bulgaria
Facility Name
Call For Information
City
Pleven
Country
Bulgaria
Facility Name
Call For Information
City
Sofia
Country
Bulgaria
Facility Name
Call For Information
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Call For Information
City
Osijek
Country
Croatia
Facility Name
Call For Information
City
Zagreb
Country
Croatia
Facility Name
Call For Information
City
Belgrade
Country
Former Serbia and Montenegro
Facility Name
Call For Information
City
Niska Banja
Country
Former Serbia and Montenegro
Facility Name
Call For Information
City
Zemun
Country
Former Serbia and Montenegro
Facility Name
Call For Information
City
Bytom
Country
Poland
Facility Name
Call For Information
City
Krakow
Country
Poland
Facility Name
Call for Information
City
Torun
Country
Poland
Facility Name
Call For Information
City
Zyrardow
Country
Poland
Facility Name
Call For Information
City
Novosibirsk
Country
Russian Federation
Facility Name
Call For Information
City
Saratov
Country
Russian Federation
Facility Name
Call For Information
City
St. Petersburg
Country
Russian Federation
Facility Name
Call For Information
City
Ljubljana
Country
Slovenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19404957
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. Erratum In: Arthritis Rheum. 2009 Oct;60(10):3071.
Results Reference
derived
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A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
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