Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate
NCT00043732 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2010-04-27
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.
Conditions
Interventions
- DRUG
-
SCIO-469
Sponsors & Collaborators
-
Scios, Inc.
lead INDUSTRY
Principal Investigators
-
Scios, Inc. Clinical Trial · Scios, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Completion
- 2003-09-30
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