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This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P38 Inhibitor (4) 150mg | Experimental |
| |
| P38 Inhibitor (4) 25mg | Experimental |
| |
| P38 Inhibitor (4) 300mg | Experimental |
| |
| P38 Inhibitor (4) 50mg | Experimental |
| |
| P38 Inhibitor (4) 75mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P38 Inhibitor (4) 150mg | Drug | 150mg po qd |
| |
| P38 Inhibitor (4) 25mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with ACR 20 response | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with ACR 50/70 response | Week 12 | |
| Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35242 | United States | |||
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| Drug |
25mg po bid |
|
| P38 Inhibitor (4) 300mg | Drug | 300mg po qd |
|
| P38 Inhibitor (4) 50mg | Drug | 50mg po qd |
|
| P38 Inhibitor (4) 75mg | Drug | 75mg po bid |
|
| Placebo | Drug | po bid |
|
| Paradise Valley |
| Arizona |
| 85253 |
| United States |
| Tucson | Arizona | 85704 | United States |
| Tucson | Arizona | 85711 | United States |
| Tucson | Arizona | 85712 | United States |
| Escondido | California | 92025 | United States |
| Fair Oaks | California | 95628 | United States |
| Loma Linda | California | 92357 | United States |
| Riverside | California | 92501 | United States |
| Upland | California | 91786 | United States |
| Gainesville | Florida | 32607 | United States |
| Ocala | Florida | 34474 | United States |
| Ormond Beach | Florida | 32174 | United States |
| Sarasota | Florida | 34232 | United States |
| Tamarac | Florida | 33321 | United States |
| Atlanta | Georgia | 30303 | United States |
| Atlanta | Georgia | 30342 | United States |
| Macon | Georgia | 31210 | United States |
| Nampa | Idaho | 83687 | United States |
| Munster | Indiana | 46321 | United States |
| South Bend | Indiana | 46601 | United States |
| Wichita | Kansas | 67207 | United States |
| Worcester | Massachusetts | 01610 | United States |
| Traverse City | Michigan | 49684 | United States |
| Omaha | Nebraska | 68114 | United States |
| Toms River | New Jersey | 08755 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| New Hartford | New York | 13413 | United States |
| Rochester | New York | 14618 | United States |
| Belmont | North Carolina | 28012 | United States |
| North Fargo | North Dakota | 58122 | United States |
| Tulsa | Oklahoma | 74136 | United States |
| Bend | Oregon | 97701 | United States |
| Camp Hill | Pennsylvania | 17011 | United States |
| Pittsburgh | Pennsylvania | 15237 | United States |
| Wilkes-Barre | Pennsylvania | 18711 | United States |
| Sioux Falls | South Dakota | 57105 | United States |
| Jackson | Tennessee | 38305 | United States |
| Knoxville | Tennessee | 37909 | United States |
| Memphis | Tennessee | 38104 | United States |
| Amarillo | Texas | 79106 | United States |
| Bryan | Texas | 77802 | United States |
| Carrollton | Texas | 75007 | United States |
| Lubbock | Texas | 79424 | United States |
| Norfolk | Virginia | 23502 | United States |
| Everett | Washington | 98201 | United States |
| Seattle | Washington | 98133 | United States |
| Monroe | Wisconsin | 53566 | United States |
| Caboolture | 4510 | Australia |
| Fitzroy | 3065 | Australia |
| Kippa-Ring | 4021 | Australia |
| Curitiba | 80060-240 | Brazil |
| Goiânia | 74043-110 | Brazil |
| São Paulo | 04266-010 | Brazil |
| Edmonton | Alberta | T5H 3V9 | Canada |
| Winnipeg | Manitoba | R3N 0K6 | Canada |
| St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Mississauga | Ontario | L5M 2V8 | Canada |
| Ottawa | Ontario | K2G 6E2 | Canada |
| Toronto | Ontario | M4K 1N2 | Canada |
| Toronto | Ontario | M5T 2S8 | Canada |
| Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Tallinn | 10128 | Estonia |
| Tallinn | 11312 | Estonia |
| Tallinn | 13419 | Estonia |
| Bad Nauheim | 61231 | Germany |
| Berlin | 12200 | Germany |
| Berlin | 14059 | Germany |
| Erfurt | 99096 | Germany |
| Erlangen | 91054 | Germany |
| Leipzig | 04107 | Germany |
| München | 80336 | Germany |
| Wiesbaden | 65191 | Germany |
| Athens | 115 27 | Greece |
| Athens | 11521 | Greece |
| Heraklion | 71003 | Greece |
| Ioannina | 455 00 | Greece |
| Thessaloniki | 56403 | Greece |
| Dublin | 4 | Ireland |
| Dublin | 9 | Ireland |
| Guadalajara | 44620 | Mexico |
| Mexico City | 03100 | Mexico |
| Monterrey | 64460 | Mexico |
| San Luis Potosí City | 78240 | Mexico |
| Auckland | 2025 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Lower Hutt | 5010 | New Zealand |
| Elblag | 82-300 | Poland |
| Sopot | 81-759 | Poland |
| Szczecin | 71-252 | Poland |
| Torun | 87-100 | Poland |
| Warsaw | 02-256 | Poland |
| Warsaw | 02-637 | Poland |
| Bloemfontein | 9301 | South Africa |
| Cape Town | 7500 | South Africa |
| Durban | 4001 | South Africa |
| Johannesburg | 1619 | South Africa |
| Pretoria | 0002 | South Africa |
| A Coruña | 15006 | Spain |
| Barcelona | 08003 | Spain |
| Barcelona | 08035 | Spain |
| Córdoba | 14004 | Spain |
| Lugo | 27004 | Spain |
| Madrid | 28034 | Spain |
| Sabadell | 08208 | Spain |
| San Cristóbal de La Laguna | 38320 | Spain |
| Basingstoke | RG24 9NA | United Kingdom |
| Cannock | WS11 5XY | United Kingdom |
| Harrogate | HG2 7SX | United Kingdom |
| Leeds | LS7 4SA | United Kingdom |
| Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |
| Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Southampton | SO16 6YD | United Kingdom |
| Wigan | WN6 9EW | United Kingdom |
| 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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