drugset / Trial / NCT00043732

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

NCT00043732

Phase 2 Completed 120 enrolled Scios, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
Primary completion
Completion
2003-09

Drugs

EvaluationDrugModalityDoseRoute
Subject TALMAPIMOD Small molecule 30 mg
Subject TALMAPIMOD Small molecule 60 mg
Subject TALMAPIMOD Small molecule 90 mg
Subject TALMAPIMOD Small molecule 180 mg

Indications