Determining the effectiveness and safety of iguratimod with the background therapy of methotrexate in the rheumatoid arthritis Patients: a randomized double blinded placebo-controlled study

Rheumatoid arthritis (RA) is an autoimmune inflammatory disease primarily characterized by synovitis. It causes pain, swelling, and stiffness of multiple joints and leads to joint destruction. It can be progressed rapidly after onset, resulting in irreversible physical dysfunction and deformation of the affected joints. Worldwide 18 million people (prevalence 0.46% of global population) are living with RA and around 70% are women and 55% of them are from postmenopausal age group. In India, the prevalence of RA is estimated to be 0.7%. Most commonly the diagnosis is made through American College of Rheumatology – European alliance of Associations for Rhuematology (ACR-EULAR) 2010 Criteria. That is based on Joints involvement, serology, acute phase reactants and duration of symptoms. A score of 6 or more out of a possible maximum of 10 constitutes a classification of ‘definite’ RA. The first line treatment starts with Methotrexate (MTX), a Conventional Synthetic Disease Modifying Anti-Rheumatic Drug (csDMARDs) used as monotherapy or in combinations with other drugs. Iguratimod (IGU) is a new small molecule, an immunomodulator, inhibiting T and B-cell differentiation, reducing inflammation. It was approved in China (2011), Japan (2012) and more recently in India in 2019. The present study is planned to determine the effectiveness and safety of IGU in comparison with placebo as add on to MTX in RA patients.