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

Ajanta Pharma Ltd0 个研究点目标入组 244 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

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