Health Condition 1: M340- Progressive systemic sclerosis
Conditions
Interventions
Intervention1: Rituximab Standard Dose: Rituximab 1 G IV will be given twice two weeks apart
Control Intervention1: Rituximab low dose: Rituximab 500 mg will be given twice two weeks apart
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Patients with SSc as diagnosed by ACR 2013. Duration of SSc for less than 10 years with onset defined as the appearance of the first non Raynauds symptom. Consenting to participate in the study. FVC of 40 percent or above the standard population, age matched. HRCT chest suggestive of ILD (more than 10 percent of lung parenchyma).
Exclusion criteria
Exclusion criteria: Clinically significant abnormality on chest X-ray or HRCT other than ILD changes (for example lung mass, effusion). Pregnant or lactating females. Severe pulmonary arterial hypertension (mPAP more than 55mmHg) requiring drug therapy. Active infection. Active myositis. Prior use of rituximab in the last six months. Positive for Hepatitis B surface antigen or Anti Hepatitis C virus antibody before the baseline visit. Serum creatinine more than 2 mg/dl. Serum ALT or AST more than 2 times ULN. Active malignancy or history of malignancy in the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the change in forced vital capacity (FVC) (%) in subjects with systemic sclerosis- Interstitial lung disease(SSc-ILD) when treated with Rituximab Standard Dose versus Low dose RituximabTimepoint: 0 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in modified Rodnan score (mRSS) at 24 weeks 2. Absolute change from baseline in FVC in litres at 24 weeks 3. Change in 6-minute walking distance at 24 weeks 4. To compare the change in Quality of Life (QoL) scores by Medical Outcomes Short Form (SF-36) and dyspnea scores by Mahler Dyspnea index at 24 weeks 5. All-cause mortality at 24 weeks 6. Incidence of adverse effects between the two groups 7. Peripheral B Cell depletion in standard dose versus low dose rituximab assessed by flowcytometry 8. Immunoglobulin profile pre and post treatment in standard dose versus low dose rituximab 9. Change in disease activity as assessed by 18F-FDG PET CT in standard dose versus low dose rituximab. 10. Difference in the cost incurred in the two arms based on Markov modelTimepoint: 0 and 24 weeks | — |
Countries
India
Contacts
Public ContactDr Shefali Khanna Sharma
Post Graduate Institute of Medical education and Research, Chandigarh
Outcome results
None listed