Treatment of Scleroderma- with immunosuppressive agents: Rituximab versus Cyclophosphamide
Phase 3
Completed
- Conditions
- Health Condition 1: null- Diffuse systemic sclerosisHealth Condition 2: M340- Progressive systemic sclerosis
- Registration Number
- CTRI/2017/07/009152
- Lead Sponsor
- Institute of Post Graduate Medical Education and Research Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1.Patients of diffuse systemic sclerosis, fulfilling the ACR classification criteria for diagnosis22, will be enrolled in the study.
2.Patients will be positive for antiScl-70
3.Patients have ILD by HRCT criteria, or pulmonary function testing, or both.
4. Female patients will be willing to adopt barrier contraception during this period.
Exclusion Criteria
1.Patients who have received cyclophosphamide or rituximab in the last year
2.Patients with pregnancy or breast-feeding
3.Patients with active systemic infections.
4.Patients with hepatitis B and C, HIV infections, tuberculosis and overlap syndromes
e.Patients with severe pulmonary hypertension (NYHA class IV)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method