A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

NCT00316771 | Completed Phase 2

• 1 other identifier: PA18439
• Study Type: interventional
• Target: 374
• Locations: 13 countries
• Sites: 111

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with ACR 20 response

  Week 12

Secondary Outcomes (2)

• 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

Study Arms (6)

P38 Inhibitor (4) 150mg

EXPERIMENTAL

Drug: P38 Inhibitor (4) 150mg

P38 Inhibitor (4) 25mg

EXPERIMENTAL

Drug: P38 Inhibitor (4) 25mg

P38 Inhibitor (4) 300mg

EXPERIMENTAL

Drug: P38 Inhibitor (4) 300mg

P38 Inhibitor (4) 50mg

EXPERIMENTAL

Drug: P38 Inhibitor (4) 50mg

P38 Inhibitor (4) 75mg

EXPERIMENTAL

Drug: P38 Inhibitor (4) 75mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

P38 Inhibitor (4) 150mg DRUG

150mg po qd

P38 Inhibitor (4) 150mg

P38 Inhibitor (4) 25mg DRUG

25mg po bid

P38 Inhibitor (4) 25mg

P38 Inhibitor (4) 300mg DRUG

300mg po qd

P38 Inhibitor (4) 300mg

P38 Inhibitor (4) 50mg DRUG

50mg po qd

P38 Inhibitor (4) 50mg

P38 Inhibitor (4) 75mg DRUG

75mg po bid

P38 Inhibitor (4) 75mg

Placebo DRUG

po bid

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients \>=18 years of age;
• active rheumatoid arthritis;
• current inadequate clinical response to methotrexate.

You may not qualify if:

• receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (114)

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Birmingham, Alabama, 35242, United States

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Paradise Valley, Arizona, 85253, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85711, United States

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Tucson, Arizona, 85712, United States

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Escondido, California, 92025, United States

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Fair Oaks, California, 95628, United States

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Loma Linda, California, 92357, United States

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Riverside, California, 92501, United States

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Upland, California, 91786, United States

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Gainesville, Florida, 32607, United States

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Ocala, Florida, 34474, United States

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Ormond Beach, Florida, 32174, United States

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Sarasota, Florida, 34232, United States

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Tamarac, Florida, 33321, United States

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Atlanta, Georgia, 30303, United States

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Atlanta, Georgia, 30342, United States

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Macon, Georgia, 31210, United States

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Nampa, Idaho, 83687, United States

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Munster, Indiana, 46321, United States

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South Bend, Indiana, 46601, United States

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Wichita, Kansas, 67207, United States

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Worcester, Massachusetts, 01610, United States

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Traverse City, Michigan, 49684, United States

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Omaha, Nebraska, 68114, United States

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Toms River, New Jersey, 08755, United States

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Albuquerque, New Mexico, 87102, United States

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New Hartford, New York, 13413, United States

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Rochester, New York, 14618, United States

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Belmont, North Carolina, 28012, United States

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North Fargo, North Dakota, 58122, United States

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Tulsa, Oklahoma, 74136, United States

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Bend, Oregon, 97701, United States

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Camp Hill, Pennsylvania, 17011, United States

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Pittsburgh, Pennsylvania, 15237, United States

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Wilkes-Barre, Pennsylvania, 18711, United States

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Sioux Falls, South Dakota, 57105, United States

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Jackson, Tennessee, 38305, United States

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Knoxville, Tennessee, 37909, United States

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Memphis, Tennessee, 38104, United States

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Amarillo, Texas, 79106, United States

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Bryan, Texas, 77802, United States

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Carrollton, Texas, 75007, United States

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Lubbock, Texas, 79424, United States

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Norfolk, Virginia, 23502, United States

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Everett, Washington, 98201, United States

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Seattle, Washington, 98133, United States

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Monroe, Wisconsin, 53566, United States

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Caboolture, 4510, Australia

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Fitzroy, 3065, Australia

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Kippa-Ring, 4021, Australia

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Curitiba, 80060-240, Brazil

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Goiânia, 74043-110, Brazil

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São Paulo, 04266-010, Brazil

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Edmonton, Alberta, T5H 3V9, Canada

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Winnipeg, Manitoba, R3N 0K6, Canada

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St. John's, Newfoundland and Labrador, A1A 5E8, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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Ottawa, Ontario, K2G 6E2, Canada

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Toronto, Ontario, M4K 1N2, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Tallinn, 10128, Estonia

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Tallinn, 11312, Estonia

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Tallinn, 13419, Estonia

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Bad Nauheim, 61231, Germany

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Berlin, 12200, Germany

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Berlin, 14059, Germany

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Erfurt, 99096, Germany

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Erlangen, 91054, Germany

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Leipzig, 04107, Germany

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München, 80336, Germany

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Wiesbaden, 65191, Germany

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Athens, 115 27, Greece

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Athens, 11521, Greece

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Heraklion, 71003, Greece

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Ioannina, 455 00, Greece

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Thessaloniki, 56403, Greece

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Dublin, 4, Ireland

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Dublin, 9, Ireland

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Guadalajara, 44620, Mexico

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Mexico City, 03100, Mexico

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Monterrey, 64460, Mexico

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San Luis Potosí City, 78240, Mexico

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Auckland, 2025, New Zealand

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Christchurch, 8011, New Zealand

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Lower Hutt, 5010, New Zealand

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Elblag, 82-300, Poland

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Sopot, 81-759, Poland

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Szczecin, 71-252, Poland

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Torun, 87-100, Poland

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Warsaw, 02-256, Poland

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Warsaw, 02-637, Poland

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Bloemfontein, 9301, South Africa

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Cape Town, 7500, South Africa

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Durban, 4001, South Africa

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Johannesburg, 1619, South Africa

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Pretoria, 0002, South Africa

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A Coruña, 15006, Spain

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Barcelona, 08003, Spain

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Barcelona, 08035, Spain

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Córdoba, 14004, Spain

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Lugo, 27004, Spain

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Madrid, 28034, Spain

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Sabadell, 08208, Spain

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San Cristóbal de La Laguna, 38320, Spain

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Basingstoke, RG24 9NA, United Kingdom

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Cannock, WS11 5XY, United Kingdom

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Harrogate, HG2 7SX, United Kingdom

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Leeds, LS7 4SA, United Kingdom

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Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Wigan, WN6 9EW, United Kingdom

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 21, 2006
• Study Start: November 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

AU (3); ES (8); DE (8); NZ (3); IE (2); GB (8); CA (8); PL (6); BR (3); US (48); GR (5); ME (4); ZA (5)