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Phase 2 Clinical 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
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University - Sofia
  • Military Medical Academy - Sofia
  • Transport Hospital
  • MBAL "Stara Zagora" EAD
  • Thalassotherapia
  • KBC Osijek Ambulanta za bol
  • University Hospital Centre Zagreb
  • University Hospital U Sv.Anny
  • University Hospital Kralovske Vinohrady
  • SZZ-Jizni Mesto II
  • Institute of Rheumatology
  • Rheumatology Out-patient Department
  • Institute of Rheumatology
  • Institute of Rheumatology - Niska Banja
  • Clinical Center Zemun
  • Szpital Specjalistyczny Nr 1
  • Wojewodzki Szpital Zespolony
  • Malopolskie Centrum Medyczne
  • "Gabinety Profesorow" Prywatna Praktyka
  • Instytut Medycyny Wsi im. Witolda Chodzki
  • Wojewodzki Zespoￅﾂ Reumatologiczny im.
  • NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy
  • Okregowy Szpital Kolejowy
  • ZOZ Zyrardow
  • Pirogov City Clinical Hospital #1
  • State Institute of Rheumatology of RAMS
  • State Clinical Immunology Research
  • Ryazan Regional Clinical Cardiologic
  • Saint Petersburg Clinical Hospital
  • Saint-Petersburg City Hospital
  • Saint-Petersburg Medical Academy
  • Saratov Regional Clinical Hospital
  • City Pokrovskaya Hospital
  • EVIDENCE Clinical and Pharmaceutical Research
  • Leningrad Regional Hospital
  • National Institute of Rheumatic Diseases
  • Clinical Center Ljubljana
  • Dniepropetrovsk State Medical Academy
  • Donetsk State Medical University
  • Institute of Cardiology of Ukranian AMS
  • Institute of Gerontology of Ukrainian AMS
  • SanaClis s.r.o.
  • Zaporizhya Medical Institute

Outcomes

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.

Full Information

First Posted
September 12, 2005
Last Updated
December 5, 2007
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00205478
Brief Title
Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (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 clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.

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
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
VX-702
Primary Outcome Measure Information:
Title
The primary endpoint for the study is the ACR20 response at Week 12.
Secondary Outcome Measure Information:
Title
The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.

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: 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.
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
Medical University - Sofia
City
Sofia
Country
Bulgaria
Facility Name
Military Medical Academy - Sofia
City
Sofia
Country
Bulgaria
Facility Name
Transport Hospital
City
Sofia
Country
Bulgaria
Facility Name
MBAL "Stara Zagora" EAD
City
Stara Zagora
Country
Bulgaria
Facility Name
Thalassotherapia
City
Opatija
Country
Croatia
Facility Name
KBC Osijek Ambulanta za bol
City
Osijek
Country
Croatia
Facility Name
University Hospital Centre Zagreb
City
Zagreb
Country
Croatia
Facility Name
University Hospital U Sv.Anny
City
Brno
Country
Czech Republic
Facility Name
University Hospital Kralovske Vinohrady
City
Praha 10
Country
Czech Republic
Facility Name
SZZ-Jizni Mesto II
City
Praha 11
Country
Czech Republic
Facility Name
Institute of Rheumatology
City
Praha 2
Country
Czech Republic
Facility Name
Rheumatology Out-patient Department
City
Praha 6
Country
Czech Republic
Facility Name
Institute of Rheumatology
City
Beograd
Country
Former Serbia and Montenegro
Facility Name
Institute of Rheumatology - Niska Banja
City
Niska Banja
Country
Former Serbia and Montenegro
Facility Name
Clinical Center Zemun
City
Zemun
Country
Former Serbia and Montenegro
Facility Name
Szpital Specjalistyczny Nr 1
City
Bytom
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony
City
Elblag
Country
Poland
Facility Name
Malopolskie Centrum Medyczne
City
Krakow
Country
Poland
Facility Name
"Gabinety Profesorow" Prywatna Praktyka
City
Lublin
Country
Poland
Facility Name
Instytut Medycyny Wsi im. Witolda Chodzki
City
Lublin
Country
Poland
Facility Name
Wojewodzki Zespoￅﾂ Reumatologiczny im.
City
Sopot
Country
Poland
Facility Name
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy
City
Torun
Country
Poland
Facility Name
Okregowy Szpital Kolejowy
City
Wroclaw
Country
Poland
Facility Name
ZOZ Zyrardow
City
Zyrardow
Country
Poland
Facility Name
Pirogov City Clinical Hospital #1
City
Moscow
Country
Russian Federation
Facility Name
State Institute of Rheumatology of RAMS
City
Moscow
Country
Russian Federation
Facility Name
State Clinical Immunology Research
City
Novosibirsk
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Cardiologic
City
Ryazan
Country
Russian Federation
Facility Name
Saint Petersburg Clinical Hospital
City
Saint Petersburg
Country
Russian Federation
Facility Name
Saint-Petersburg City Hospital
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Saint-Petersburg Medical Academy
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Saratov Regional Clinical Hospital
City
Saratov
Country
Russian Federation
Facility Name
City Pokrovskaya Hospital
City
St. Petersburg
Country
Russian Federation
Facility Name
EVIDENCE Clinical and Pharmaceutical Research
City
St. Petersburg
Country
Russian Federation
Facility Name
Leningrad Regional Hospital
City
St. Petersburg
Country
Russian Federation
Facility Name
National Institute of Rheumatic Diseases
City
Piestany
Country
Slovakia
Facility Name
Clinical Center Ljubljana
City
Ljubljana
Country
Slovenia
Facility Name
Dniepropetrovsk State Medical Academy
City
Dniepropetrovsk
Country
Ukraine
Facility Name
Donetsk State Medical University
City
Donetsk
Country
Ukraine
Facility Name
Institute of Cardiology of Ukranian AMS
City
Kiev
Country
Ukraine
Facility Name
Institute of Gerontology of Ukrainian AMS
City
Kiev
Country
Ukraine
Facility Name
SanaClis s.r.o.
City
Kiev
Country
Ukraine
Facility Name
Zaporizhya Medical Institute
City
Zaporizhya
Country
Ukraine

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

Learn more about this trial

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

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