Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
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
1 other identifier
interventional
300
8 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Jun 2005
Shorter than P25 for phase_2 rheumatoid-arthritis
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedDecember 7, 2007
December 1, 2007
September 12, 2005
December 5, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint for the study is the ACR20 response at Week 12.
Secondary Outcomes (1)
The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.
Interventions
Eligibility Criteria
You may qualify if:
- Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.
You may not qualify if:
- Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Medical University - Sofia
Sofia, Bulgaria
Military Medical Academy - Sofia
Sofia, Bulgaria
Transport Hospital
Sofia, Bulgaria
MBAL "Stara Zagora" EAD
Stara Zagora, Bulgaria
Thalassotherapia
Opatija, Croatia
KBC Osijek Ambulanta za bol
Osijek, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia
University Hospital U Sv.Anny
Brno, Czechia
Institute of Rheumatology
Prague, Czechia
Rheumatology Out-patient Department
Prague, Czechia
SZZ-Jizni Mesto II
Prague, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
Szpital Specjalistyczny Nr 1
Bytom, Poland
Wojewodzki Szpital Zespolony
Elblag, Poland
Malopolskie Centrum Medyczne
Krakow, Poland
"Gabinety Profesorow" Prywatna Praktyka
Lublin, Poland
Instytut Medycyny Wsi im. Witolda Chodzki
Lublin, Poland
Wojewodzki Zespoￅﾂ Reumatologiczny im.
Sopot, Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy
Torun, Poland
Okregowy Szpital Kolejowy
Wroclaw, Poland
ZOZ Zyrardow
Żyrardów, Poland
Pirogov City Clinical Hospital #1
Moscow, Russia
State Institute of Rheumatology of RAMS
Moscow, Russia
State Clinical Immunology Research
Novosibirsk, Russia
Ryazan Regional Clinical Cardiologic
Ryazan, Russia
City Pokrovskaya Hospital
Saint Petersburg, Russia
EVIDENCE Clinical and Pharmaceutical Research
Saint Petersburg, Russia
Leningrad Regional Hospital
Saint Petersburg, Russia
Saint Petersburg Clinical Hospital
Saint Petersburg, Russia
Saint-Petersburg City Hospital
Saint Petersburg, Russia
Saint-Petersburg Medical Academy
Saint Petersburg, Russia
Saratov Regional Clinical Hospital
Saratov, Russia
Institute of Rheumatology
Beograd, Serbia and Montenegro
Institute of Rheumatology - Niska Banja
Niska Banja, Serbia and Montenegro
Clinical Center Zemun
Zemun, Serbia and Montenegro
National Institute of Rheumatic Diseases
Piešťany, Slovakia
Clinical Center Ljubljana
Ljubljana, Slovenia
Dniepropetrovsk State Medical Academy
Dniepropetrovsk, Ukraine
Donetsk State Medical University
Donetsk, Ukraine
Institute of Cardiology of Ukranian AMS
Kiev, Ukraine
Institute of Gerontology of Ukrainian AMS
Kiev, Ukraine
SanaClis s.r.o.
Kiev, Ukraine
Zaporizhya Medical Institute
Zaporizhya, Ukraine
Related Publications (1)
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.
PMID: 19404957DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Kauffman, MD, PhD
Vertex Pharmaceuticals Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
June 1, 2005
Study Completion
February 1, 2006
Last Updated
December 7, 2007
Record last verified: 2007-12