A Phase 2 interventional study of SCIO-469 and SCIO-469 in Arthritis, Rheumatoid, sponsored by Scios, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-18.
Sponsored by Scios, Inc. · Phase 2, Interventional, and Treatment
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).
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 302 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Scios, Inc. is the lead sponsor of 20 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SCIO-469 30 mg capsule three times daily for 12 weeks
Drug: SCIO-469
SCIO-469 60 mg capsule three times daily for 12 weeks
Drug: SCIO-469
SCIO-469 100 mg tablet once daily for 12 weeks
Drug: SCIO-469
Placebo 2 capsules three times daily and one tablet daily
Drug: Placebo
60 mg capsule three times daily for 12 weeks
30 mg capsule three times daily for 12 weeks
2 capsules three times daily and one tablet daily
100 mg tablet once daily for 12 weeks
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)
Time frame: Day 1 to approximately Day 85 of treatment
ACR50 responders at Week 12
Time frame: 12 weeks
ACR20 and ACR50 responders at each evaluation visit other than Week 12
Time frame: 24 weeks
All individual variables of the ACR response criteria at each evaluation visit
Time frame: 24 weeks
Disease Activity Score (DAS)28 at each evaluation visit.
Time frame: 24 Weeks
The number of participants experiencing adverse events (AEs) as a measure of safety
Time frame: 24 weeks
No study locations are listed for this record.
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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Scios, Inc.