A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study of SCIO-469 in Patients in Active Rheumatoid Arthritis Receiving Methotrexate
This multicenter, randomized, double-blind, placebo-controlled, dose-escalating study will
assess the safety, tolerability, efficacy, PK and pharmacodynamics of SCIO-469 in patients
with active RA who also are receiving methotrexate. A total of 120 subjects will be
randomly assigned and treated in one of seven dose groups with the total daily dose of
SCIO-469 ranging from 0 to 180 mg. Dose groups will be staggered over four Treatment
Periods. Safety and available PK data from a Treatment Period with lower dose groups will be
reviewed prior to initiating higher dose groups in the next Treatment Period. Placebo
subjects will be randomized in all Treatment Periods. Study drug will be taken for 30 days.
Each subject will be followed for approximately 4 weeks after completing the 30-day
Treatment Period. Safety will be assessed by way of physical examination, medical history,
vital signs, orthostatic vital signs, chest radiograph, 12-lead electrocardiogram (ECG),
clinical laboratory evaluations (including serum chemistry, hematology, qualitative
urinalysis, and liver function tests), purified protein derivative test for tuberculosis,
neurological tests, adverse events, and concomitant medications through out the study. Study
drug will be administered for 30 days at one of the following dosage strengths; 30 mg, 60
mg, 90 mg. One group of subjects will get 60 mg for one week followed by 120 for one week
followed by 180 mg for two weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Assess the safety and tolerability of multiple oral doses of SCIO-469 in patients with active rheumatoid arthritis (RA) who were also receiving stable doses of methotrexate (MTX).
Scios, Inc. Clinical Trial
United States: Food and Drug Administration