Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: Rapid escalation group oral Methotrexate: Tablet Methotrexate Start at a dose of 15 mg per week and increase by 5 mg every TWO weeks till reach a maximum dose of 25 mg per week
Control
Sponsors
Postgraduate Institute of Medical Education and Research PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria 2.Between 18 years to 50 year of age 3.Disease duration less than 5 years since persistent arthritis 4.Having active disease: Atleast 4 tender joints and atleast 2 swollen joints 5.Not on methotrexate in the last 6 months 6.Weight > 45 Kg 7.Permitted to be on corticosteroids if dose stable for at least 2 weeks and dose 8.Permitted to be on hydroxychloroquine, if dose stable for at least 2 weeks before randomization
Exclusion criteria
Exclusion criteria: 1.Pregnant 2.Breastfeeding 3.Standard exclusion for MTX treatment a.Chronic liver disease b.Renal failure (Creatinine more than 1.3 mg per dl) c.Any leucopenia ( less than 4000) or thrombocytopenia ( less than 1,00,000) d.Transaminitis (SGOT or SGPT more than 40 IU/L) e.Breast-feeding f.Desirous of pregnancy in the next 6 months g.Known Hepatitis B or C positive h.Known clinically relevant chronic lung disease: ILD and FVC less than 70% i.Tuberculosis or other active infections: CXR screening j.Known HIV positive 4.Already on sulfasalazine or leflunomide more than 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare proportion of good responders by EULAR response criteria to methotrexateTimepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Compare laboratory adverse effects ââ?¬â?? Transaminitis (SGOT or SGPT more than 80 IU/L) and Cytopenias (TLC less than 4000 OR Platelet less than 1,00,000)Timepoint: Ever;Compare delta DAS28-3 at 16 weeks between the two groups.Timepoint: 16 weeks;Compare symptomatic adverse effects ââ?¬â?? by PerformaTimepoint: Ever (8 or 16 weeks) | — |
Countries
India
Contacts
Public ContactVarun Dhir
Postgraduate Institute of Medical Education and Research (PGIMER)
Outcome results
None listed