Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Methotrexate: Split-Dose MTX Group
25mg once weekly
(Morning-10mg + Evening-15mg)
Control Intervention1: Methotrexate: Single Dose MTX Group
25mg once weekly
Sponsors
Postgraduate Institute Of Medical Education And Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed as RA based on ACR/EULAR 2010 criteria. 2. RF or CCP positive 3. Age between 18 years to 60 years. 4. Those who give written informed consent to participate in study. 5. Weight equal or more than 40 Kg. 6. Having active disease: At least 4 tender joints and at least 2 swollen joints. 7. Not in Class 4 functional status (i.e. those who are completely dependent). 8. Disease duration less than 5 years (since onset of persistent arthritis). 9. Patients on oral Corticosteroid (less than or equal to 10mg/day), and/or Hydroxychloroquine (up to 400mg/day) allowed, if stable doses for last 1 month prior to enrolment.
Exclusion criteria
Exclusion criteria: 1.Should not be currently on methotrexate and should not have received methotrexate for atleast the last 6 months. 2. Should not currently be on sulfasalazine or leflunomide and should not have received them for at least the last 2 months. 3. Use of biologicals therapies (anti-TNF alpha, Rituximab, Tocilizumab) in the last 6-months. 4.Previous history of Methotrexate intolerance in the past in terms of severe symptomatic side effects like nausea etc. 5. Should not have received JAKinibs (Tofacitinib or Baricitinib) within the last 1 month. 6. Should not have received any Intramuscular or intra-articular depot methylpred/triamcinolone in the last 10 days. 7.Standard exclusion for MTX treatment; I.Any leucopenia ( II.Creatinine > 1.3 mg per dl done within 1-week of enrolment. III.SGOT or SGPT more than 50 IU/L (normal being 40 IU/L) done within 1-week of enrolment. IV.Hepatitis B or C or HIV positive. V.Known case of Chronic liver disease. VI.Either Pregnant or lactating. VII.Desirous of pregnancy in the next 6 months. VIII. Known chronic lung disease like bronchiectasis or known case of ILD (with FVC less than 70%). IX.Active Tuberculosis or other active infections:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Good Responder by Eular response criteria based on DAS28Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare laboratory adverse effects – episodes of significant transaminitis ( 80 IU/L or higher) or cytopenia (TLC less than 4000/mm3 or platelet less than 1,00,000/mm3)Timepoint: At 2, 4, 8, 16 and 24 weeks.;Compare proportion of patients with American College of Rheumatology (ACR) 20 response between the two groups.Timepoint: 16 and 24 weeks.;Compare serious adverse effects like infection, death, hospitalization or suspected pulmonary toxicity between the two groups.Timepoint: At 24 weeks.;Compare symptomatic adverse effects between the two groups.Timepoint: 16 and 24 weeks.;Compare the change in serum TNF-alpha, MMP3, IL-6 levels AND RBC MTX PG levels between the two groupsTimepoint: 24 weeks.;Compare the improvement in HAQ (Indian) between the two groups.Timepoint: 16 and 24 weeks;Good Responder by Eular response criteria based on das28Timepoint: 16 weeks | — |
Countries
India
Contacts
Public ContactDr VARUN DHIR
Postgraduate Institute Of Medical Education And Research, Chandigarh
Outcome results
None listed