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).
- Conditions
- Patients with active rheumatoid arthritis who are on a stable dose of methotrexate
- Registration Number
- EUCTR2008-006917-25-PL
- Lead Sponsor
- uon Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method