Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00205478
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.
- Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint for the study is the ACR20 response at Week 12.
- Secondary Outcome Measures
Name Time Method The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.
Trial Locations
- Locations (42)
Dniepropetrovsk State Medical Academy
๐บ๐ฆDniepropetrovsk, Ukraine
Zaporizhya Medical Institute
๐บ๐ฆZaporizhya, Ukraine
MBAL "Stara Zagora" EAD
๐ง๐ฌStara Zagora, Bulgaria
Transport Hospital
๐ง๐ฌSofia, Bulgaria
University Hospital Kralovske Vinohrady
๐จ๐ฟPraha 10, Czech Republic
Military Medical Academy - Sofia
๐ง๐ฌSofia, Bulgaria
Wojewodzki Szpital Zespolony
๐ต๐ฑElblag, Poland
Pirogov City Clinical Hospital #1
๐ท๐บMoscow, Russian Federation
Rheumatology Out-patient Department
๐จ๐ฟPraha 6, Czech Republic
Malopolskie Centrum Medyczne
๐ต๐ฑKrakow, Poland
Instytut Medycyny Wsi im. Witolda Chodzki
๐ต๐ฑLublin, Poland
Szpital Specjalistyczny Nr 1
๐ต๐ฑBytom, Poland
Institute of Gerontology of Ukrainian AMS
๐บ๐ฆKiev, Ukraine
Medical University - Sofia
๐ง๐ฌSofia, Bulgaria
Thalassotherapia
๐ญ๐ทOpatija, Croatia
KBC Osijek Ambulanta za bol
๐ญ๐ทOsijek, Croatia
Institute of Rheumatology - Niska Banja
Niska Banja, Former Serbia and Montenegro
University Hospital Centre Zagreb
๐ญ๐ทZagreb, Croatia
SZZ-Jizni Mesto II
๐จ๐ฟPraha 11, Czech Republic
Institute of Rheumatology
Beograd, Former Serbia and Montenegro
University Hospital U Sv.Anny
๐จ๐ฟBrno, Czech Republic
Clinical Center Zemun
Zemun, Former Serbia and Montenegro
"Gabinety Profesorow" Prywatna Praktyka
๐ต๐ฑLublin, Poland
Wojewodzki Zespo๏ฟ ๏พ Reumatologiczny im.
๐ต๐ฑSopot, Poland
State Clinical Immunology Research
๐ท๐บNovosibirsk, Russian Federation
Ryazan Regional Clinical Cardiologic
๐ท๐บRyazan, Russian Federation
Saint Petersburg Clinical Hospital
๐ท๐บSaint Petersburg, Russian Federation
Saint-Petersburg City Hospital
๐ท๐บSaint-Petersburg, Russian Federation
Saint-Petersburg Medical Academy
๐ท๐บSaint-Petersburg, Russian Federation
EVIDENCE Clinical and Pharmaceutical Research
๐ท๐บSt. Petersburg, Russian Federation
National Institute of Rheumatic Diseases
๐ธ๐ฐPiestany, Slovakia
Clinical Center Ljubljana
๐ธ๐ฎLjubljana, Slovenia
SanaClis s.r.o.
๐บ๐ฆKiev, Ukraine
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy
๐ต๐ฑTorun, Poland
Okregowy Szpital Kolejowy
๐ต๐ฑWroclaw, Poland
ZOZ Zyrardow
๐ต๐ฑZyrardow, Poland
State Institute of Rheumatology of RAMS
๐ท๐บMoscow, Russian Federation
Saratov Regional Clinical Hospital
๐ท๐บSaratov, Russian Federation
Leningrad Regional Hospital
๐ท๐บSt. Petersburg, Russian Federation
City Pokrovskaya Hospital
๐ท๐บSt. Petersburg, Russian Federation
Donetsk State Medical University
๐บ๐ฆDonetsk, Ukraine
Institute of Cardiology of Ukranian AMS
๐บ๐ฆKiev, Ukraine