This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
50mg po qd
150mg po qd
300mg po qd
Percentage of patients with ACR 20 response
Time frame: Week 12
Percentage of patients with ACR 50/70 response.
Time frame: Week 12
Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.
Time frame: Throughout study
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po qd
Unnamed facility
Anniston, Alabama, United States
Unnamed facility
Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
Unnamed facility
Escondido, California, United States
Unnamed facility
Loma Linda, California, United States
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Stamford, Connecticut, United States
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Morton Grove, Illinois, United States
Unnamed facility
South Bend, Indiana, United States
Unnamed facility
Wichita, Kansas, United States
...and 51 more locations