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11日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•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 15 mg/week for >6 months;
•Subjects must receive at least 5 mg 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 that last 6 months;
•Subjects may be receiving greater than or equal to 10 mg/day prednisone (or equivalent), chronic NSAIDS if stable dose, hydroxychloroquine 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;
•Use of other anti-arthritic treatments;
•Pregnant or nursing females;
•Subjects with any laboratory test at screening considered significantly abnormal;
•Elevated bilirubin or history of clinically significant renal or hepatic dysfunction;
•History of uric acid urolithiasis or gout;
•Clinically significant systemic infection;
•Evidence of TB;

发起方

uon Therapeutics, Inc.