CTRI/2017/07/009079CompletedPhase 3
A Comparative, Two Arm, Randomized, Double Blind, Parallel Group, Multicentric, Non-Inferior Clinical Study to Evaluate Efficacy, Safety and Tolerability of Iguratimod Tablets 25 mg as an add on Therapy over Methotrexate Tablets 15 mg Vs. Methotrexate Tablets 25 mg for the treatment of Patients with Active Rheumatoid Arthritis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ajanta Pharma Ltd
- Enrollment
- 244
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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