A study to compare the effectiveness and safety of iguratimod with methotrexate in rheumatoid arthritis patients
Phase 4
- Conditions
- Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
- Registration Number
- CTRI/2024/05/067140
- Lead Sponsor
- Midhun Sakravarthy J
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in DAS-28 ESR scoreTimepoint: 0, 12 weeks and 24 weeks
- Secondary Outcome Measures
Name Time Method 1. Change in Hgb, Total WBC, Platelets count, Serum Creatinine, ALT, AST <br/ ><br>2. Adverse reactions <br/ ><br>3. Change in ESR, CRP levels <br/ ><br>4. ACR 20/50/70Timepoint: 1.0 and every 4 weeks upto 24 weeks <br/ ><br>2. 0 and every 4 weeks upto 24 weeks <br/ ><br>3. 0, 12th week, 24th week <br/ ><br>4. 12th week and 24th week