drugset / Trial / NCT02644499

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

NCT02644499

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be conducted to find out how well a patient of rheumatoid arthritis (RA) will respond to disease-modifying antirheumatic drugs (DMARDs). RA is a chronic inflammatory arthritis, which leads to joint damage \& disability if not treated properly. A DMARD is used to treat RA that slows down or prevents joint damage, as opposed to just relieve pain or inflammation by painkillers. The study will be conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education \& Research). Patients will receive either a single DMARD (Methotrexate) or combination DMARDs therapy (Methotrexate + Leflunomide + Hydroxychloroquine). During treatment course, routine blood investigations will be carried out to monitor treatment response and side effects.

Timeline

Start
2015-12-31
Primary completion
2017-02-17
Completion
2017-09-15

Drugs

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

Indications