Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that causes progressive damage to joints of the body, affecting the functional capacity. Effective management of patients with RA requires a multidisciplinary approach. Despite the various combinations, there is a significant population of RA patients who are not responding to these combinations or showing inadequate response to methotrexate alone. Hence, there is a need for a unique combination of drugs targeting different pathological process to yield the best results in those patients where prognosis is poor. Combination of revamilast with first line therapy like methotrexate could provide better treatment options to a larger population of RA patients having moderate to severe disease and who are inadequately controlled on one or the other DMARDs. This is randomized, double-blind, placebo-controlled, parallel group study. The study will include patients with active RA receiving stable and maximum tolerated dose of MTX. Patients will be recruited after providing written informed consent. After screening and run in period (single blind placebo for 4 weeks), patients will be randomized (meeting randomization criteria) in 1:2:2:2 ratios to receive either one of three doses (Low, Medium and High) of revamilast or placebo along with MTX. The primary objective of the study is to determine the percentage of patients achieving ACR20 response at 12 weeks. Secondary objectives include determining percentage of patients with ACR50 and ACR70 response, change in DAS-28 score, change in serum CRP and ESR values and frequency and use of rescue medication. During the treatment period, there will be 5 further study visits at week 2, week 4, week 8, week 12, for efficacy, safety and tolerability assessment and visit at week 14 will be follow up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
406
Tablet, Low dose, Once daily for 12 weeks
Tablet, Medium dose, Once daily for 12 weeks
Tablet, High dose, Once daily for 12 weeks
Matching Placebo in triple dummy format, Tablet, Once daily for 12 weeks
Advance Rheumatology Clinic
Hyderabad, Andhra Pradesh, India
Mahavir Hospital and Research Center
Hyderabad, Andhra Pradesh, India
Sri Deepti Rheumatology Center
Hyderabad, Andhra Pradesh, India
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh, India
Rathi Orthopaedic & Research Center
Ahmedabad, Gujarat, India
Percentage of patients achieving ACR20 response
Time frame: 12 weeks
Percentage of patients achieving ACR50 and ACR 70 response
Time frame: 12 weeks
Change in DAS-28 score
Time frame: week 12
Change in serum CRP and ESR values
Time frame: 12 weeks
Frequency and use of rescue medication
Time frame: 12 weeks
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