SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate
- Registration Number
- NCT00089921
- Lead Sponsor
- Scios, Inc.
- Brief Summary
The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).
- Detailed Description
This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
- Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs)
- Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study
- Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
- Lab tests revealed elevated liver enzymes within the past 6 months
- Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy
- HIV positive
- Abnormal electrocardiogram
- Chronic or acute infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 004 Placebo Placebo 2 capsules three times daily and one tablet daily 001 SCIO-469 SCIO-469 30 mg capsule three times daily for 12 weeks 002 SCIO-469 SCIO-469 60 mg capsule three times daily for 12 weeks 003 SCIO-469 SCIO-469 100 mg tablet once daily for 12 weeks
- Primary Outcome Measures
Name Time Method ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR) Day 1 to approximately Day 85 of treatment
- Secondary Outcome Measures
Name Time Method ACR50 responders at Week 12 12 weeks ACR20 and ACR50 responders at each evaluation visit other than Week 12 24 weeks All individual variables of the ACR response criteria at each evaluation visit 24 weeks Disease Activity Score (DAS)28 at each evaluation visit. 24 Weeks The number of participants experiencing adverse events (AEs) as a measure of safety 24 weeks