Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
Summary
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.