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 subjects with rheumatoid arthritis. The primary objective of this study is to determine the...
Date First Received: August 17, 2004
Last Updated: June 23, 2005
Verified by: Scios, Inc., June 2005
Clinical Trial Phase: Phase 2 | Start Date: July 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 300
Brief Summary
Official Title: “A Phase II, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine”
Condition Keyword(s):
Intervention(s):
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 subjects with rheumatoid arthritis.
The primary objective of this study is to determine the efficacy of oral SCIO-469 in subjects with rheumatoid arthritis who are not receiving hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs).
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: SCIO-469
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Subjects have active rheumatoid arthritis and are not receiving DMARDs
- Subjects taking hydroxychloroquine (Plaquenil) must be on a stable dose
Exclusion Criteria:
- Used Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
- Elevation of liver enzymes within the past 6 months
- Tuberculosis
- Cancer
- HIV-positive
- Abnormal electrocardiogram
- Chronic or acute infection
- Multiple sclerosis, neuropathy, encephalopathy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Scios, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00089921
Study ID Number: SCIO-469/B007
ClinicalTrials.gov Identifier: NCT00089921
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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