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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
374
150mg po qd
25mg po bid
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, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.
Time frame: Throughout study
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50mg po qd
75mg po bid
po bid
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Paradise Valley, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Escondido, California, United States
Unnamed facility
Fair Oaks, California, United States
Unnamed facility
Loma Linda, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
Upland, California, United States
...and 104 more locations