A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00316771
First received: April 20, 2006
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: P38 Inhibitor (4) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Percentage of patients with ACR 20 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of patients with ACR 50/70 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 374 |
| Study Start Date: | November 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: P38 Inhibitor (4)
50mg po qd
|
| Experimental: 2 |
Drug: P38 Inhibitor (4)
150mg po qd
|
| Experimental: 3 |
Drug: P38 Inhibitor (4)
300mg po qd
|
| Experimental: 4 |
Drug: P38 Inhibitor (4)
25mg po bid
|
| Experimental: 5 |
Drug: P38 Inhibitor (4)
75mg po bid
|
| Placebo Comparator: 6 |
Drug: Placebo
po bid
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients >=18 years of age;
- active rheumatoid arthritis;
- current inadequate clinical response to methotrexate.
Exclusion Criteria:
- receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316771
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| United States, Alabama | |
| Birmingham, Alabama, United States, 35242 | |
| United States, Arizona | |
| Paradise Valley, Arizona, United States, 85253 | |
| Tucson, Arizona, United States, 85704 | |
| Tucson, Arizona, United States, 85711 | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Escondido, California, United States, 92025 | |
| Fair Oaks, California, United States, 95628 | |
| Loma Linda, California, United States, 92357 | |
| Riverside, California, United States, 92501 | |
| Upland, California, United States, 91786 | |
| United States, Florida | |
| Gainesville, Florida, United States, 32607 | |
| Ocala, Florida, United States, 34474 | |
| Ormond Beach, Florida, United States, 32174 | |
| Sarasota, Florida, United States, 34232 | |
| Tamarac, Florida, United States, 33321 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30342 | |
| Atlanta, Georgia, United States, 30303 | |
| Macon, Georgia, United States, 31210 | |
| United States, Idaho | |
| Nampa, Idaho, United States, 83687 | |
| United States, Indiana | |
| Munster, Indiana, United States, 46321 | |
| South Bend, Indiana, United States, 46601 | |
| United States, Kansas | |
| Wichita, Kansas, United States, 67207 | |
| United States, Massachusetts | |
| Worcester, Massachusetts, United States, 01610 | |
| United States, Michigan | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Jersey | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| New Hartford, New York, United States, 13413 | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| Belmont, North Carolina, United States, 28012 | |
| United States, North Dakota | |
| North Fargo, North Dakota, United States, 58122 | |
| United States, Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Bend, Oregon, United States, 97701 | |
| United States, Pennsylvania | |
| Camp Hill, Pennsylvania, United States, 17011 | |
| Wexford, Pennsylvania, United States, 15090 | |
| Wilkes-barre, Pennsylvania, United States, 18711 | |
| United States, South Dakota | |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Tennessee | |
| Jackson, Tennessee, United States, 38305 | |
| Knoxville, Tennessee, United States, 37909 | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Amarillo, Texas, United States, 79106 | |
| Bryan, Texas, United States, 77802 | |
| Carrollton, Texas, United States, 75007 | |
| Lubbock, Texas, United States, 79424 | |
| United States, Virginia | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Everett, Washington, United States, 98201 | |
| Seattle, Washington, United States, 98133 | |
| United States, Wisconsin | |
| Monroe, Wisconsin, United States, 53566 | |
| Australia | |
| Caboolture, Australia, 4510 | |
| Fitzroy, Australia, 3065 | |
| Kippa Ring, Australia, 4021 | |
| Brazil | |
| Curitiba, Brazil, 80060-240 | |
| Goiania, Brazil, 74043-110 | |
| Sao Paulo, Brazil, 04266-010 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3N 0K6 | |
| Canada, Newfoundland and Labrador | |
| St John's, Newfoundland and Labrador, Canada, A1A 5E8 | |
| Canada, Ontario | |
| Mississauga, Ontario, Canada, L5M 2V8 | |
| Ottawa, Ontario, Canada, K2G 6E2 | |
| Toronto, Ontario, Canada, M4K 1N2 | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| Pointe-claire, Quebec, Canada, H9R 3J1 | |
| Sainte-foy, Quebec, Canada, G1W 4R4 | |
| Estonia | |
| Tallinn, Estonia, 13419 | |
| Tallinn, Estonia, 10128 | |
| Tallinn, Estonia, 11312 | |
| Germany | |
| Bad Nauheim, Germany, 61231 | |
| Berlin, Germany, 12200 | |
| Berlin, Germany, 14059 | |
| Erfurt, Germany, 99096 | |
| Erlangen, Germany, 91054 | |
| Leipzig, Germany, 04107 | |
| Muenchen, Germany, 80336 | |
| Wiesbaden, Germany, 65191 | |
| Greece | |
| Athens, Greece, 11521 | |
| Athens, Greece, 11527 | |
| Heraklion, Greece, 71003 | |
| Ioannina, Greece, 45500 | |
| Thessaloniki, Greece, 56403 | |
| Ireland | |
| Dublin, Ireland, 9 | |
| Dublin, Ireland, 4 | |
| Mexico | |
| Guadalajara, Mexico, 44620 | |
| Mexico City, Mexico, 03100 | |
| Monterrey, Mexico, 64460 | |
| San Luis Potosi, Mexico, 78240 | |
| New Zealand | |
| Auckland, New Zealand, 2025 | |
| Christchurch, New Zealand, 8011 | |
| Lower Hutt, New Zealand, 5010 | |
| Poland | |
| Elblag, Poland, 82-300 | |
| Sopot, Poland, 81-759 | |
| Szczecin, Poland, 71-252 | |
| Torun, Poland, 87-100 | |
| Warszawa, Poland, 02-256 | |
| Warszawa, Poland, 02-637 | |
| South Africa | |
| Bloemfontein, South Africa, 9301 | |
| Cape Town, South Africa, 7500 | |
| Durban, South Africa, 4001 | |
| Johannesburg, South Africa, 1619 | |
| Pretoria, South Africa, 0002 | |
| Spain | |
| Barcelona, Spain, 08003 | |
| Barcelona, Spain, 08035 | |
| Córdoba, Spain, 14004 | |
| La Coruna, Spain, 15006 | |
| La Laguna, Spain, 38320 | |
| Lugo, Spain, 27004 | |
| Madrid, Spain, 28034 | |
| Sabadell, Spain, 08208 | |
| United Kingdom | |
| Basingstoke, United Kingdom, RG24 9NA | |
| Cannock, United Kingdom, WS11 5XY | |
| Harrogate, United Kingdom, HG2 7SX | |
| Leeds, United Kingdom, LS7 4SA | |
| Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
| Southampton, United Kingdom, SO16 6YD | |
| Wigan, United Kingdom, WN6 9EW | |
| Wirral, United Kingdom, CH49 5PE | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00316771 History of Changes |
| Other Study ID Numbers: | PA18439 |
| Study First Received: | April 20, 2006 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013