Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |