Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
Conditions
Interventions
Intervention1: METHOTREXATE plus IGURATIMOD: METHOTREXATE standard dose once a week for 6 months plus IGURATIMOD 25mg, twice daily for 6 months
Control Intervention1: METHOTREAXTE plus PLACEBO: METHOT
Sponsors
Midhun Sakravarthy J
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 years to 65 years 2. Patients of either gender 3. Patients who are newly diagnosed with Seropositive Rheumatoid arthritis according to ACR-EULAR 2010 Criteria (=6 – Definite RA) with duration of less than one year and Disease Activity Score =3.2
Exclusion criteria
Exclusion criteria: 1. Impaired hepatic Function with elevated AST or ALT levels = 3 times the upper limit of normal 2. Patient with history of renal disease or impaired kidney function with elevated Serum creatinine 3. Pregnant and lactating women. 4. Known malignancies 5. Known Hepatitis B, C and HIV patients 6. Other Auto-immune diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in DAS-28 ESR scoreTimepoint: 0, 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Hgb, Total WBC, Platelets count, Serum Creatinine, ALT, AST 2. Adverse reactions 3. Change in ESR, CRP levels 4. ACR 20/50/70Timepoint: 1.0 and every 4 weeks upto 24 weeks 2. 0 and every 4 weeks upto 24 weeks 3. 0, 12th week, 24th week 4. 12th week and 24th week | — |
Countries
India
Contacts
Public ContactMehdi Ali Mirza
ESIC Medical College and Hospital
Outcome results
None listed