Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which are known to contribute to both symptoms and disease progression in patients with Rheumatoid Arthritis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Patients who have active rheumatoid arthritis and are receiving methotrexate

• meet the revised 1987 American Rheumatism Association (ARA) criteria for rheumatoid arthritis

• has active RA as demonstrated by 9 tender and 6 swollen joints and one of the following: C-reactive protein 1.0 mg/dL, Erythrocyte sedimentation rate (ESR) 28 mm/hour, or Morning stiffness = 45 minutes. .

Exclusion Criteria:

• Patient used etanercept, infliximab, anakinra, or an experimental biologic agent within past 3 months

• Had elevation of liver enzymes within past 6 months

• Has a history of Tuberculosis

• Vertigo, inner ear, or vestibular abnormalities

• Cancer

• HIV-positive

• Abnormal electrocardiogram

• patient has chronic or acute infection

• Multiple sclerosis, neuropathy or encephalopathy