[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100095860":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":7,"locations":7,"responsibleParty":7,"collaborators":7,"id":16,"slug":17,"hasResults":18,"nctId":19,"briefTitle":20,"officialTitle":21,"acronym":7,"eligibilityCriteria":22,"healthyVolunteers":18,"sex":23,"minAge":24,"maxAge":7,"enrollmentInfo":25,"targetDuration":7,"studyType":28,"phases":29,"briefSummary":31,"conditions":32,"keywords":34,"overallStatus":36,"whyStopped":7,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":7,"completionDateStruct":41,"leadSponsor":43,"locationsCount":7},{"fullName":5,"class":6},"Scios, Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Oral SCIO-469 capsule",[13],{"name":14,"affiliation":5,"role":15},"Scios, Inc. Clinical Trial","STUDY_DIRECTOR","100095860","phase-1-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-100095860",false,"NCT00508768","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","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","Inclusion Criteria:\n\n* Patients with active rheumatoid arthritis\n* Patients on methotrexate are required to have taken a stable methotrexate dose of 15 to 25 mg\u002Fweek (or lower maximum-tolerated dose level) for at least 1 month before study entry\n* Patients with no methotrexate are required to have taken no methotrexate for at least 1 month before study entry\n* 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\n* Patients of childbearing potential must have agreed to practice two forms of birth control for the duration of the trial.\n\nExclusion Criteria:\n\n* Have taken infliximab or experimental biological antagonists (e.g., TNF antagonists) within the 3-month period before study entry\n* Have used leflunomide within the 3 month period before study entry\n* Have taken etanercept, anakinra, and disease-modifying anti-rheumatic drugs (DMARDs) other than leflunomide (and methotrexate) within the 4-week period before study entry\n* Received intra-articular, intramuscular, or intravenous (IV) doses of corticosteroids or received oral doses of corticosteroids exceeding 10 mg\u002Fday within the 4-week period before study entry\n* 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.","FEMALE","18 Years",{"count":26,"type":27},16,"ACTUAL","INTERVENTIONAL",[30],"PHASE1","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.",[33],"Rheumatoid Arthritis",[33,35],"Methotrexate","COMPLETED","2011-05-18",{"date":39,"type":40},"2011-05-19","ESTIMATED",{"date":42,"type":27},"2002-12",{"name":5,"class":6}]