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

• Status: Terminated
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
• Treatments: Antirheumatic Agents; Folic Acid; Glucocorticoids; Hydroxychloroquine; Leflunomide; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sulfasalazine; Vitamin B Complex

Criteria

Inclusion Criteria:

Age >18 years satisfying ACR-EULAR criteria for RA

1. Polyarthritis (>4 joints)

2. Disease duration of less than 2 years

3. Patients with moderate to severe disease activity (DAS28>3.2)

4. Patients who have failed to respond to initial Methotrexate monotherapy

Exclusion Criteria:

1. End stage disease (deformed fixed joints)

2. Patients with vasculitis, extra-articular features like interstitial lung disease8

3. Contraindications to DMARD therapy (Chronic Alcoholism, Chronic liver disease, Evidence of acute/chronic infection, Chronic kidney disease, Patients with leucopenia (<3.0×109/l), thrombocytopenia (<150×109/l), AST/ALT>2× upper normal value and creatinine clearance <30ml/minute )

4. Pregnant, lactating women ; patients (both men and women) of reproductive age group unwilling for contraceptive use who have not completed the family

5. Patients unable to come for regular follow up