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

• Status: Completed
• Trial end date: 2017-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• 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; Vitamin B Complex

Criteria

Inclusion Criteria:

1. Age > 18 years satisfying 2010 ACR (American college of rheumatology) - EULAR criteria for RA

2. Arthritis in one or more joint (s)

3. Symptom duration <1 year

4. DMARD naive

5. Patients with moderate to severe disease activity (DAS28 ≥3.2)

Exclusion Criteria:

1. Disease in Remission/inactive disease (DAS28 criteria)

2. End stage disease (deformed fixed joints)

3. Patients with vasculitis or other severe extra-articular features

4. 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), aspartate aminotransferase (AST)/alanine aminotransferase (ALT)>2× upper normal value and creatinine level >150 μmol/l )

5. Pregnant, lactating females or inadequate contraception

6. Patients unable to come for regular follow up