Health Condition 1: G35-G37- Demyelinating diseases of the central nervous system
Conditions
Interventions
None listed
Sponsors
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH KOLKATA
Eligibility
Inclusion criteria
Inclusion criteria: a) Patients receiving maintenance Rituximab therapy for primary CNS demyelinating disorder (diagnosed as per accepted criteria for MS and NMOSD) as disease modifying therapy to prevent relapse. b) Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: i) Pregnant and Lactating females ii) Patients with history of angina, arrhythmia, congestive cardiac failure (NYHA III and IV) iii) Patients with HIV, HBV or HCV infection iv) Patients with unevaluated abdominal pain with possibilities of bowel perforation or obstruction. v) Untreated concurrent infections (mucocutaneous, respiratory, genitourinary etc) vi) Recent vaccinations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Determine CD 19/ CD 20 levels every 12 weeks by flow cytometry in primary CND demyelinating disorders. b. Determine whether administering Rituximab after determining CD19/CD20 levels, if 0.05% of blood mononuclear cells or more or rise in 1% from last measurement) is more effective in terms of : i) Reduced ARR (annual relapse rate) and improved EDSS Score Timepoint: every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactSayan Chatterjee
Institute of post graduate medical education and research, Kolkata
Outcome results
None listed