A Study of Oral SCIO-469 Pharmacokinetics (Study of a Drug in the Body to Watch How the Drug is Absorbed, Distributed, Metabolized and Eliminated Over a Period of Time) in the Body of Female Patients With Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the pharmacokinetics of two oral dosing regimens of SCIO-469, with and without methotrexate, in patients with active rheumatoid arthritis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.

Criteria

Inclusion Criteria:

• Patients with active rheumatoid arthritis

• Patients on methotrexate are required to have taken a stable methotrexate dose of 15 to 25 mg/week (or lower maximum-tolerated dose level) for at least 1 month before study entry

• Patients with no methotrexate are required to have taken no methotrexate for at least 1 month before study entry

• Non steroidal anti inflammatory drugs (NSAIDs) and low-dose prednisone are allowed if doses had been stable for at least 1 month before study entry

• Patients of childbearing potential must have agreed to practice two forms of birth control for the duration of the trial.

Exclusion Criteria:

• Have taken infliximab or experimental biological antagonists (e.g., TNF antagonists) within the 3-month period before study entry

• Have used leflunomide within the 3 month period before study entry

• Have taken etanercept, anakinra, and disease-modifying anti-rheumatic drugs (DMARDs) other than leflunomide (and methotrexate) within the 4-week period before study entry

• Received intra-articular, intramuscular, or intravenous (IV) doses of corticosteroids or received oral doses of corticosteroids exceeding 10 mg/day within the 4-week period before study entry

• Elevated levels (greater than 1.2 times the upper limit of normal) of aspartate transaminase or alanine transaminase within the 6-month period before study entry.