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

NCT ID: NCT00316771

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P38 Inhibitor (4) 150mg

Group Type EXPERIMENTAL

P38 Inhibitor (4) 150mg

Intervention Type DRUG

150mg po qd

P38 Inhibitor (4) 25mg

Group Type EXPERIMENTAL

P38 Inhibitor (4) 25mg

Intervention Type DRUG

25mg po bid

P38 Inhibitor (4) 300mg

Group Type EXPERIMENTAL

P38 Inhibitor (4) 300mg

Intervention Type DRUG

300mg po qd

P38 Inhibitor (4) 50mg

Group Type EXPERIMENTAL

P38 Inhibitor (4) 50mg

Intervention Type DRUG

50mg po qd

P38 Inhibitor (4) 75mg

Group Type EXPERIMENTAL

P38 Inhibitor (4) 75mg

Intervention Type DRUG

75mg po bid

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po bid

Interventions

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P38 Inhibitor (4) 150mg

150mg po qd

Intervention Type DRUG

P38 Inhibitor (4) 25mg

25mg po bid

Intervention Type DRUG

P38 Inhibitor (4) 300mg

300mg po qd

Intervention Type DRUG

P38 Inhibitor (4) 50mg

50mg po qd

Intervention Type DRUG

P38 Inhibitor (4) 75mg

75mg po bid

Intervention Type DRUG

Placebo

po bid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Birmingham, Alabama, United States

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Paradise Valley, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Escondido, California, United States

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Fair Oaks, California, United States

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Loma Linda, California, United States

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Riverside, California, United States

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Upland, California, United States

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Gainesville, Florida, United States

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Ocala, Florida, United States

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Ormond Beach, Florida, United States

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Sarasota, Florida, United States

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Tamarac, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Nampa, Idaho, United States

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Munster, Indiana, United States

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South Bend, Indiana, United States

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Wichita, Kansas, United States

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Worcester, Massachusetts, United States

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Traverse City, Michigan, United States

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Omaha, Nebraska, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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New Hartford, New York, United States

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Rochester, New York, United States

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Belmont, North Carolina, United States

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North Fargo, North Dakota, United States

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Tulsa, Oklahoma, United States

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Bend, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Amarillo, Texas, United States

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Bryan, Texas, United States

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Carrollton, Texas, United States

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Lubbock, Texas, United States

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Norfolk, Virginia, United States

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Everett, Washington, United States

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Seattle, Washington, United States

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Monroe, Wisconsin, United States

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Caboolture, , Australia

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Fitzroy, , Australia

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Kippa-Ring, , Australia

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Curitiba, , Brazil

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Goiânia, , Brazil

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São Paulo, , Brazil

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Bad Nauheim, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Erfurt, , Germany

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Erlangen, , Germany

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Leipzig, , Germany

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München, , Germany

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Wiesbaden, , Germany

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Athens, , Greece

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Athens, , Greece

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Heraklion, , Greece

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Ioannina, , Greece

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Thessaloniki, , Greece

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Dublin, , Ireland

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Dublin, , Ireland

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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San Luis Potosí City, , Mexico

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Lower Hutt, , New Zealand

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Elblag, , Poland

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Sopot, , Poland

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Szczecin, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Pretoria, , South Africa

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A Coruña, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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Lugo, , Spain

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Madrid, , Spain

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Sabadell, , Spain

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San Cristóbal de La Laguna, , Spain

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Basingstoke, , United Kingdom

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Cannock, , United Kingdom

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Harrogate, , United Kingdom

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Leeds, , United Kingdom

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Metropolitan Borough of Wirral, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Southampton, , United Kingdom

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Wigan, , United Kingdom

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Countries

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United States Australia Brazil Canada Estonia Germany Greece Ireland Mexico New Zealand Poland South Africa Spain United Kingdom

Other Identifiers

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PA18439

Identifier Type: -

Identifier Source: org_study_id