A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).

uon Therapeutics, Inc.0 个研究点目标入组 250 人开始时间: 2009年3月10日最近更新: 2012年3月19日

试验速览

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•Male or female subjects, =18 to =75 years of age, who have a diagnosis of RA;
•Subjects must be receiving MTX at a dose of at least 10 mg/week for =6 months;
•Subjects must receive at least 5 mg of folic acid or folinic acid per week;
•Subjects must have at least 8 painful/tender and 6 swollen joints;
•Subjects must have an elevated CRP or ESR level at screening;
•Availability of normal chest X-ray within the last 6 months (for Argentina within 1 month);
•Subjects may be receiving oral steroids at stable dose less than or equal to 10 mg/day of prednisone (or equivalent steroid), chronic NSAIDs if stable dose, hydroxychloroquine if stable dose, sulfasalazine if stable dose;
•Females of childbearing capacity must agree to contraceptive use.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Use of intra-articular corticosteroid within 1 month prior to randomization;
•Use of other anti-arthritic treatments;
•Pregnant or nursing females;
•Subjects with any laboratory test at screening considered significantly abnormal;
•Elevated total bilirubin or history of clinically significant renal or hepatic dysfunction;
•History of uric acid urolithiasis or gout;
•Clinically significant systemic infection;
•Subjects with mental impairment;
•Evidence of TB.

发起方

uon Therapeutics, Inc.