Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Intervention1: Rituximab: Injection Rituximab 1g IV divided over two days, repeated 14 days later to complete induction. Maintenance therapy of Rituximab (500mg IV over two consecutive days) would be
Sponsors
INDIAN COUNCIL OF MEDICAL RESEARCH
Eligibility
Inclusion criteria
Inclusion criteria: a) Patients with RRMS diagnosed as per the Mc. Donald s revised criteria 2017, within last two years b) Age 18-55 years c) Therapy naive/ received last immunomodulation prior to more than six months or more than 5 half-lives of DMT d) willing to provide written consent e) for females of child bearing age consent to not plan pregnancy or use adequate appropriate non- hormonal contraception methods.
Exclusion criteria
Exclusion criteria: a) Pregnancy b) age 55 years c) Any Demyelinating disease other than RRMS d) Organ failure (NYHA III or IV, Hepatic or renal failure) e) presence of infection specially evidence of Tuberculosis (latent or active in Rituximab therapy) / Triple serology positivity for one or more f) prior history of confirmed or suspected Progressive Multifocal Leukoencephalopathy (PML) for Rituximab arm g) Known ALI (acute liver injury)/ AKI (acute kidney injury) on prior exposure to drugs in the Conventional Arm or evidence of other serious organ damage that would hamper participation in study as per investigators opinion h) Severe Infusion related reaction and/ or hypersensitivity to any drug during prior exposure i) History of cancer requiring therapy in the last 10 years j) concomitant presence of other immune mediated disorders requiring therapy with other immunomodulating drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of Rituximab in RRMS patients will be measured by annual relapse rate or number of relapses per patient.Timepoint: baseline, 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Cell sorting, clustering to establish predominant cell line & HLA typing up to allelic level to i) Establish a database (descriptive analysis) & attempt to correlate between endophenotype classification & HLA variant (correlation techniques) ii) Correlate endophenotype & response to therapy using appropriate statistical analysis techniques.Timepoint: 365 days | — |
Countries
India
Contacts
Public ContactBiman Kanti Ray
Bangur Institute of neurosciences
Outcome results
None listed