Health Condition 1: I778- Other specified disorders of arteries and arterioles
Conditions
Interventions
Intervention1: Rituximab one gram , two doses fifteen days apart: Two infusions of One gram Rituximab injection each will be given at an interval of two weeks
Control Intervention1: Rituximab 375 mg/
Sponsors
Professor Aman Sharma
Eligibility
Inclusion criteria
Inclusion criteria: Age >18 years,Active vasculitis defined as BVAS = 1.
Exclusion criteria
Exclusion criteria: 1. Any active infection at the time of recruitment. 2. Active tuberculosis of any site in last six months. 3. Hepatitis B, C or human immunodeficiency virus I/II infection. 4. Abnormal liver function tests at the time of recruitment. 5. Prior use of Rituximab for remission induction in the last six months. 6. Active malignancy or history of malignancy in the last 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving remission, defined as BVASv3 of 0, at week 24.Timepoint: Proportion of patients achieving remission, defined as BVASv3 of 0, at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to remission. 2. Proportion of patients having minor relapses, defined as BVASv3 =3 with absence of major BVAS items, after achieving remission at week 24. 3. Proportion of patients having major relapses, defined as BVASv3 3 or one or more major BVAS items, after achieving remission at week 24. 4. Death from any cause. 5. Proportion of patients achieving sustained remission, defined as remission before 24 weeks & lasting until at least week 52. 6. Mean Vasculitis Damage Index (VDI) at week 52. 7. Proportion of patients with adverse events. 8. Proportion of patients with serious adverse events. 9. Proportion of patients with serious infections. 10. Proportion of patients with hypogammaglobulinemia. Timepoint: week 24 & 52 | — |
Countries
India
Contacts
Public ContactDr Aman Sharma
Post Graduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed