Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel-Group, Pharmacokinetic Study of Oral SCIO-469 (90 mg qd and 30 mg Tid) in Female Subjects With Active Rheumatoid Arthritis
Verified date | April 2010 |
Source | Scios, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Scios, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameters will be evaluated for SCIO-469 and its metabolites, testing for significant differences by occasion (Day 1 or Day 12), treatment (30 mg three times a day or 90 mg once a day), and stratum (methotrexate or non methotrexate). | |||
Secondary | Safety variables will be assessed on Day 19, seven days after the end of treatment, and will include adverse events, concomitant medications, and clinical assessments (medical history, physical exam, vital signs, 12-lead ECG, and clinical labs). |
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