| CTRI Number |
CTRI/2025/12/099888 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare different long-term treatments in people with Myelin Oligodendrocyte Glycoprotein antibody-associated disease (MOGAD) |
|
Scientific Title of Study
|
Comparative Efficacy of Maintenance immunomodulatory therapies in Myelin
Oligodendrocyte Glycoprotein antibody associated disease- an open label randomised
controlled trial with blinded outcome (CEM-MOG study) |
| Trial Acronym |
CEM-MOG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Bhatia |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical sciences , New Delhi |
| Address |
Room No. 603, 6th floor , CN centre , Department of Neurology , AIIMS , New Delhi
South West
DELHI
110029
India |
| Phone |
919891267417 |
| Fax |
|
| Email |
rohitbhatia71@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Bhatia |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical sciences , New Delhi |
| Address |
Room No. 603, 6th floor , CN centre , Department of Neurology , AIIMS , New Delhi
South West
DELHI
110029
India |
| Phone |
919891267417 |
| Fax |
|
| Email |
rohitbhatia71@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Bhatia |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical sciences , New Delhi |
| Address |
Room No. 603, 6th floor , CN centre , Department of Neurology , AIIMS , New Delhi
South West
DELHI
110029
India |
| Phone |
919891267417 |
| Fax |
|
| Email |
rohitbhatia71@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, near AIIMS, with a P.O. Box No. 4911 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Netravathi M |
National Institute of Mental Health and Neuro Sciences NIMHANS |
Department of Neurology , National Institute of Mental Health and Neuro Sciences NIMHANS No 29 Marigowda Road Hosur Road Bangalore 560029
Bangalore
KARNATAKA |
9880106662
sundernetra@yahoo.co.in |
| Dr Sruthi Nair |
Sree Chitra Tirunal Institute for Medical Sciences and Technology SCTIMST |
Department of Neurology , SCTIMST, Jai Nagar W Road, Aakulam, Thiruvananthapuram - 695 011
Thiruvananthapuram
KERALA |
9895045032
sruthisn@sctimst.ac.in |
| Dr Rohit Bhatia |
All India Institute of Medical Sciences AlIMS New Delhi |
Ansari NagaR New Delhi 110029
South West
DELHI |
09891267417
rohitbhatia71@yahoo.com |
| Dr Dheeraj Khurana |
Postgraduate Institute of Medical Education and Research PGIMER |
Department of Neurology , PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9815066990
dherajk@yahoo.com |
| Dr Thomas Mathew |
St. Johns Medical College |
Department of Neurology , St. Johns Medical College Sarjapura Main Road Koramangala 560034
Bangalore
KARNATAKA |
9880247582
chakkuthom@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institute ethics committee, AIIMS, New Delhi |
Approved |
| NIMHANS IEC |
Approved |
| PGI Institutional Ethics Committee |
Submittted/Under Review |
| SCTIMST Institue Ethics Committee |
Submittted/Under Review |
| St Johns Medical College Institutional Ethics committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G378||Other specified demyelinating diseases of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Rituximab |
Induction dose 2 g (1 g × 2 infusions, 14 days apart), followed by 500–600 mg every 6 months per protocol. Premedication as per guidelines; vaccination optional. Route: intravenous. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
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 months). Route: oral. |
| Intervention |
Tablet Mycophenolate Mofetil |
Started at 500 mg once daily and increased by 500 mg weekly to a total dose of 2 g/day with CBC and LFT monitoring (weekly × 4 weeks, monthly × 3 months, then every 3 months). Route: oral. |
| Intervention |
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 be used. Prednisolone would be continued at a full dose for a period of 6-8 weeks and then tapered slowly by 5 mg every week until it is stopped. The treating
physician has the freedom to either stop the steroid completely or maintain on a small dose. For Rituximab arm the steroid full dose will be given for 4 weeks and then a similar steroid tapering schedule would be used. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients who remained relapse-free at 2 years while receiving each of the maintenance immunotherapies . |
Each patient will be followed up at 6,12,18,24 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first relapse |
Each patient will be followed up at 6,12,18,24 months. |
| EDSS at last follow up |
Each patient will be followed up at 6,12,18,24 months. |
| Change of disease modifying treatment |
Each patient will be followed up at 6,12,18,24 months. |
| Any adverse event |
Each patient will be followed up at 6,12,18,24 months. |
| Any serious adverse event |
Each patient will be followed up at 6,12,18,24 months. |
| Any Infection during study period |
Each patient will be followed up at 6,12,18,24 months. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction Myelin Oligodendrocyte Glycoprotein Antibody Associated Disease MOGAD is a heterogeneous neuroimmunological disease with a spectrum of clinical manifestations which include optic neuritis myelitis encephalomyelitis or encephalitis alone or in combination. A considerable number of patients approximately 50 percent have a relapsing course. There is an absence of Level 1 evidence for choice of maintenance immunosuppression in these patients. A randomised controlled trial is needed to guide treatment decisions. This study will be the first ever randomised controlled trial in the world to evaluate the comparative efficacy of commonly used therapeutic maintenance immunomodulatory therapies among patients with MOGAD. Objectives The primary objective is to compare the efficacy of Azathioprine or Mycophenolate Mofetil or Rituximab in preventing relapses among patients with MOGAD as defined by proportion of patients who are relapse free for at least 2 years of follow up. Methods In this multicenter open label randomised trial with blinded outcomes all adult MOGAD patients diagnosed as per the Lancet 2023 criteria would be included and randomised equally in permuted block randomisation to receive either AZA or MMF or RTX. The proportion of patients who are relapse free at the end of the follow up period of 2 years would be calculated. Expected outcome The study will help ascertain benefits of individual medications and help compare efficacy between them. Since there is no data on head to head comparative studies in this group of patients the study may help decide choice of medications among MOGAD patients. |