A Study of Oral SCIO-469 Pharmacokinetics (Study of a Drug in the Body to Watch How the Drug is Absorbed, Distributed, Metabolized and Eliminated Over a Period of Time) in the Body of Female Patients With Active Rheumatoid Arthritis

NCT00508768 | Completed Phase 1

• 1 other identifier: CR005155
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Methotrexate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Interventions

Oral SCIO-469 capsule DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scios, Inc.: lead

Related Links

• A Pharmacokinetic Study of Oral SCIO-469 in Female Subjects with Active Rheumatoid Arthritis

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

SCIO-469

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 30, 2007
• Study Completion: December 1, 2002
• Last Updated: May 19, 2011

Record last verified: 2010-04