Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years satisfying 2010 ACR (American college of rheumatology) - EULAR criteria for RA
- Arthritis in one or more joint (s)
- Symptom duration <1 year
- DMARD naive
- Patients with moderate to severe disease activity (DAS28 ≥3.2)
Exclusion Criteria:
- Disease in Remission/inactive disease (DAS28 criteria)
- End stage disease (deformed fixed joints)
- Patients with vasculitis or other severe extra-articular features
- 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 )
- Pregnant, lactating females or inadequate contraception
- Patients unable to come for regular follow up
Sites / Locations
- Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Combination therapy
Monotherapy
Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 15 mg/day, weeks 2-4: 10 mg/day, weeks 4-6: 5 mg/day and weeks 6-8: 2.5 mg/day then stop) will be given as bridging therapy.
Methotrexate (up to 25 mg once a week) for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 15 mg/day, weeks 2-4: 10 mg/day, weeks 4-6: 5 mg/day and weeks 6-8: 2.5 mg/day then stop) will be given as bridging therapy.