A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
NCT ID: NCT00303563
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2006-04-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
P38 Inhibitor (4)
50mg po qd
2
P38 Inhibitor (4)
150mg po qd
3
P38 Inhibitor (4)
300mg po qd
4
Placebo
po qd
Interventions
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P38 Inhibitor (4)
50mg po qd
P38 Inhibitor (4)
150mg po qd
P38 Inhibitor (4)
300mg po qd
Placebo
po qd
Eligibility Criteria
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Inclusion Criteria
* receiving treatment for RA on an outpatient basis;
* females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.
Exclusion Criteria
* rheumatic autoimmune disease or inflammatory joint disease other than RA;
* treatment with methotrexate within 8 weeks of baseline;
* concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Anniston, Alabama, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Escondido, California, United States
Loma Linda, California, United States
Stamford, Connecticut, United States
Morton Grove, Illinois, United States
South Bend, Indiana, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Belmont, North Carolina, United States
Bend, Oregon, United States
Danville, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Dallas, Texas, United States
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Rijeka, , Croatia
Split, , Croatia
České Budějovice, , Czechia
Prague, , Czechia
Terezín, , Czechia
Zlín, , Czechia
Brest, , France
Corbeil-Essonnes, , France
Montpellier, , France
Paris, , France
Rouen, , France
Brescia, , Italy
Genova, , Italy
Pavia, , Italy
Roma, , Italy
Guadalajara, , Mexico
Guadalajara, , Mexico
Miexico City, , Mexico
Brasov, , Romania
Bucharest, , Romania
Belgrade, , Serbia
Bloemfontein, , South Africa
Johannesburg, , South Africa
Pretoria, , South Africa
A Coruña, , Spain
Barcelona, , Spain
Granada, , Spain
Jerez de la Frontera, , Spain
Madrid, , Spain
Oviedo, , Spain
Palma de Mallorca, , Spain
Seville, , Spain
Kaohsiung City, , Taiwan
Taoyuan District, , Taiwan
Tapei, , Taiwan
Countries
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Other Identifiers
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PA18604
Identifier Type: -
Identifier Source: org_study_id