A study on the immunological response of Rituximab on primary CNS demyelinating disorders in terms of safety and efficacy
Not Applicable
- Conditions
- Health Condition 1: G35-G37- Demyelinating diseases of the central nervous system
- Registration Number
- CTRI/2020/05/025384
- Lead Sponsor
- INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH KOLKATA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method