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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-702 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint for the study is the ACR20 response at Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Kauffman, MD, PhD | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University - Sofia | Sofia | Bulgaria | ||||
| Military Medical Academy - Sofia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19404957 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C517771 | VX 702 |
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