A Clinical Study to Evaluate Efficacy, Safety and Tolerability of Iguratimod Tablets Vs. Methotrexate Tablets for the treatment of Active Rheumatoid Arthritis.
- Conditions
- Health Condition 1: null- Active Rheumatoid ArthritisHealth Condition 2: E888- Other specified metabolic disorders
- Registration Number
- CTRI/2017/07/009079
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 244
1.Subjects who had been diagnosed with active RA, according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for Rheumatoid Arthritis (ACR) criteria, and Disease Activity Score 28 (DAS28) greater than or equal to 3.2.
2.Tender joint count/swollen joint count >=6.
3.Patients who have failed at least one cycle of DMRD therapy, defined as subject who has failed to achieve remission after Methotrexate 15mg/week regime for 3 months.
1.Subjects who have participated in other clinical studies within 3 months.
2.Any condition which are likely to hinder the compliance with the protocol.
3.Subjects suffering under treatment of any chronic infection.
4.Subject with history of intra-articular infection within last four weeks.
5.Subjects with dosage of steroids more than 7.5mg/day.
6.Patients not on a stable dose of steroids for last 1 month.
7.Patients with significant systemic manifestations of rheumatoid arthritis.
8.Rheumatic auto-immune disease other than rheumatoid arthritis/overlap syndromes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects meeting the American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response criteria.Timepoint: At the end of week 28
- Secondary Outcome Measures
Name Time Method Mean Change from baseline in Health Assessment Questionnaire (HAQ).Timepoint: At the end of week 28