Health Condition 1: null- Diffuse systemic sclerosis Health Condition 2: M340- Progressive systemic sclerosis
Conditions
Interventions
Intervention1: Rituximab: A chimeric monoclonal antibody to CD 20, which effectively destroys B cells and is therefore used to treat diseases which are characterized by excessive numbers of B cells, o
Sponsors
Institute of Post Graduate Medical Education and Research Kolkata
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes will be the 1. Change in forced vital capacity (FVC) at six months, and 2. Modified Rodnan skin scores at 6 months. Timepoint: 0 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Histologic appearance of fibrosis, 2. Six-minute walk test results, 3. Presence of pulmonary hypertension by echocardiographic criteria, 4. Change in BDI/TDI scores 5. Assessment of HRCT. Timepoint: 0 and 6 months | — |
Countries
India
Contacts
Public ContactParasar Ghosh
Institute of Postgraduate Medical Education and Research, Kolkata
Outcome results
None listed