A Phase 2 interventional study of SCIO-469 in Rheumatoid Arthritis, sponsored by Scios, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-27.
Sponsored by Scios, Inc. · Phase 2, Interventional, and Treatment
The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. 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 patients with Rheumatoid Arthritis.
This multicenter, randomized, double-blind, placebo-controlled, dose-escalating study will assess the safety, tolerability, efficacy, PK and pharmacodynamics of SCIO-469 in patients with active RA who also are receiving methotrexate. A total of 120 subjects will be randomly assigned and treated in one of seven dose groups with the total daily dose of SCIO-469 ranging from 0 to 180 mg. Dose groups will be staggered over four Treatment Periods. Safety and available PK data from a Treatment Period with lower dose groups will be reviewed prior to initiating higher dose groups in the next Treatment Period. Placebo subjects will be randomized in all Treatment Periods. Study drug will be taken for 30 days. Each subject will be followed for approximately 4 weeks after completing the 30-day Treatment Period. Safety will be assessed by way of physical examination, medical history, vital signs, orthostatic vital signs, chest radiograph, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests), purified protein derivative test for tuberculosis, neurological tests, adverse events, and concomitant medications through out the study. Study drug will be administered for 30 days at one of the following dosage strengths; 30 mg, 60 mg, 90 mg. One group of subjects will get 60 mg for one week followed by 120 for one week followed by 180 mg for two weeks.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 120 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.
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Exclusion Criteria:
Assess the safety and tolerability of multiple oral doses of SCIO-469 in patients with active rheumatoid arthritis (RA) who were also receiving stable doses of methotrexate (MTX).
To assess the efficacy of multiple oral doses of SCIO-469 using the American College of Rheumatology (ACR) response criteria. To determine the PK of multiple oral doses of SCIO-469 in patients with active RA who are also receiving MTX.
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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Scios, Inc.