It is a study to compare the effectiveness and safety of oral and injectable steroids in systemic lupus erythematosus
Phase 3
- Conditions
- Health Condition 1: M329- Systemic lupus erythematosus, unspecified
- Registration Number
- CTRI/2024/03/063624
- Lead Sponsor
- IMS and SUM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients aged 18 years and above with SLEDAI score more than 10 fulfilling the EULAR criteria
Exclusion Criteria
1. Patients on any treatment within last 3 months
2. Patients having features of other connective tissue diseases
3. Patients with other autoimmune conditions
4. Patients with pre-existing chronic renal failure, previous
malignancy, and liver dysfunction, within six months prior
to randomization.
5. Patients with previously documented severe toxicity to
immunosuppressive drugs.
6. Patients with active acute or chronic infections.
7. Pregnancy and lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical assessment <br/ ><br>SLAM-R score <br/ ><br>Routine investigations (Complete Blood count, Liver function tests, Renal function tests, Urine routine microscopy)Timepoint: At Week 4, 8, 12, 16, 20, and 24.
- Secondary Outcome Measures
Name Time Method Adverse effects due to the drugs if anyTimepoint: At the end of 24 weeks