drugset / Trial / NCT02930343

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

NCT02930343

RandomizedParallel-groupOpen-labelTreatment

Summary

RA (Rheuatoid arthritis) is a multisystem disease that mainly involves joints resulting in destructive arthritis if not treated rapidly. Inspite of various advances in field of early diagnosis and treatment of RA, there is still a need for better understanding of the efficacy and safety of various combinations of conventional DMARDS, and to rank them in order accordingly, so as to give a clearer vision for further management of RA once MTX monotherapy fails, so as to achieve remission as soon as possible. The study will be conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education \& Research). patients who fail methotrexate monotherapy will be randomised to 2 treatment arms - either a combination of Sulfasalazine (SSZ), Hydroxychloroquine (HCQ) and Methotrexate (MTX) or Leflunomide (LEF), Hydroxychloroquine (HCQ) and Methotrexate (MTX)

Timeline

Start
2016-09
Primary completion
2018-08
Completion
2018-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leflunomide Small molecule 20 mg Oral
Comparator Sulfasalazine Small molecule 2 g Oral
Comparator Hydroxychloroquine Small molecule 200 mg Oral
Comparator Hydroxychloroquine Small molecule 400 mg Oral
Comparator Methotrexate Small molecule 25 mg Oral
Comparator Prednisolone Other / unclassified 5 mg Oral
Comparator folic acid Other / unclassified 5 mg Oral

Indications