Health Condition 1: G378- Other specified demyelinating diseases of central nervous system
Conditions
Interventions
Intervention1: Tablet Azathioprine: Started at 25 mg/day and increased by 25 50 mg weekly to a target of ~2 mg/kg/day with CBC and LFT monitoring (weekly 4 weeks, monthly 3 months, then every 3 mo
vaccination optional. Route: intravenous.
Intervention4: Tablet Prednisolone: Tablet prednisolone will be given at a dose of 1 mg/kg per day in all patients.A standard steroid tapering schedule would
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (18 years and above). Diagnosed with MOGAD with a typical clinical phenotype in the form of optic neuritis, myelitis, tumefactive demyelination and acute disseminated encephalitis/encephalomyelitis and positive MOG antibody using a cell based study and fulfilling the Lancet 2023 consensus criteria for MOGAD. Not on active immunosuppression Written informed consent
Exclusion criteria
Exclusion criteria: Current or a prior history of receiving any form of immunomodulation other than oral steroids Diagnosis other than MOGAD Contraindication to the use of these agents Denial of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who remained relapse-free at 2 years while receiving each of the maintenance immunotherapies .Timepoint: Each patient will be followed up at 6,12,18,24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first relapseTimepoint: Each patient will be followed up at 6,12,18,24 months.;EDSS at last follow upTimepoint: Each patient will be followed up at 6,12,18,24 months.;Change of disease modifying treatmentTimepoint: Each patient will be followed up at 6,12,18,24 months.;Any adverse eventTimepoint: Each patient will be followed up at 6,12,18,24 months.;Any serious adverse eventTimepoint: Each patient will be followed up at 6,12,18,24 months.;Any Infection during study periodTimepoint: Each patient will be followed up at 6,12,18,24 months. | — |
Countries
India
Contacts
Public ContactDr Rohit Bhatia
All India Institute of Medical sciences , New Delhi
Outcome results
None listed