Rheumatoid Arthritis Clinical Trial
Official title:
A Multicenter, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG-760564 in Adult Patients With RA Receiving Methotrexate
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
The study will be conducted in North America and Europe at approximately 50 to 60 sites.
Approximately 270 patients will be randomized, of which 189 are expected to complete the
study.
The study will consist of a screening visit followed by a washout period for all disease
modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout
period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine,
etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for
abatacept.
After the washout period, the patients determined to be eligible will be randomized to
receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There
will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after
the last treatment visit (Week 16). Patients will not initiate new therapies until after the
4-week follow-up is completed. Liver function tests will be evaluated at every visit.
The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response
criteria after 12 weeks of treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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