Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Methotrexate split dose twice weekly: This group will split oral methotrexate on 2 days in a week (Monday and Thursday) and will be followed for 6 months
Intervention2: Prescribing two
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients fulfilling ACR/EULAR 2010 criteria of Rheumatoid Arthritis and having moderate disease activity, which is defined by DAS28 3.2 2) Patients who are more than or equal to 18 years old 3) Patients taking oral methotrexate for at least 1 month prior to inclusion in this study 4) Giving consent for participation in the study. 5) Methotrexate dose less than or equal to 15mg/week 6) Not on other conventional synthetic or biological DMARDs except HCQ ( 400mg) or low dose prednisolone (7.5 mg)
Exclusion criteria
Exclusion criteria: 1) Contraindications to methotrexate â?? severe renal, pulmonary and liver disease, pre- existing bone marrow suppression, alcoholic liver disease, pregnancy, breastfeeding or patients planning conception, acute or chronic HBV or HCV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess change in disease severity measures (SDAI, CDAI and DAS28) at 24 weeks compared to baseline and side effect profile (symptomatic & labs) at 24 weeks.Timepoint: 1, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess Mean Glucocorticoid dose and NSAID score at 24 weeks 2. To assess Methotrexate intolerance severity score at 24 weeks.Timepoint: 1, 3 and 6 months | — |
Countries
India
Contacts
Public ContactRajat Gupta
King George Medical University
Outcome results
None listed