| CTRI Number |
CTRI/2026/01/101385 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Multicentre open label non inferior RCT in RRMS endopphenotypic classification : RITREC. |
|
Scientific Title of Study
|
A Multicentre open label non inferior RCT in RRMS of rituximab and conventional therapy and way forward precision medicine with RRMS endophenotypic classification: RITREC. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Biman Kanti Ray |
| Designation |
Professor |
| Affiliation |
Bangur Institute of neurosciences |
| Address |
Department of Neuromedicine, 2nd floor, Bangur Institute of neurosciences New Block, 52/1a, Sambhunath Pandit St, Gokhel Road, Bhowanipore
Kolkata
WEST BENGAL
700020
India Sambhunath Pandit Street Kolkata WEST BENGAL 700020 India |
| Phone |
9433185327 |
| Fax |
|
| Email |
biman.kanti@rediffmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Biman Kanti Ray |
| Designation |
Professor |
| Affiliation |
Bangur Institute of neurosciences |
| Address |
Department of Neuromedicine, 2nd floor, Bangur Institute of neurosciences New Block, 52/1a, Sambhunath Pandit St, Gokhel Road, Bhowanipore
Kolkata
WEST BENGAL
700020
India Sambhunath Pandit Street Kolkata WEST BENGAL 700020 India |
| Phone |
9433185327 |
| Fax |
|
| Email |
biman.kanti@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Biman Kanti Ray |
| Designation |
Professor |
| Affiliation |
Bangur Institute of neurosciences |
| Address |
Department of Neuromedicine, 2nd floor, Bangur Institute of neurosciences New Block, 52/1a, Sambhunath Pandit St, Gokhel Road, Bhowanipore
Kolkata
WEST BENGAL
700020
India Sambhunath Pandit Street Kolkata WEST BENGAL 700020 India |
| Phone |
9433185327 |
| Fax |
|
| Email |
biman.kanti@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| INDIAN COUNCIL OF MEDICAL RESEARCH,NEW DELHI |
|
|
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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Biman Kanti Ray |
Bangur institute of Neurosciences, IPGME&R, Dept. of Neuromedicine |
Sambhunath Pandit Street Kolkata WEST BENGAL |
09433185327
biman.kanti@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G35||Multiple sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DMF Interferon Beta 1a Teriflunomide |
conventional drugs would be administered as per physicians’ discretion, patient’s individual choice and standard institute protocol. Interferon Beta 1a (thrice weekly subcutaneous injection), DMF (240 mg twice daily) and Teriflunomide (14 mg daily) administered orally. |
| Intervention |
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 administered by monitoring CD19/CD20 cell counts (when CD19 cell count 1% of total CD 45 + B cells). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
a) Pregnancy b) age <18 or >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. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of Rituximab in RRMS patients will be measured by annual relapse rate or number of relapses per patient. |
baseline, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
365 days |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="1" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Multiple sclerosis (MS) is an autoimmune disorder affecting individuals in their reproductive years, significantly impacting physical, psychological, and socioeconomic well-being. Treating relapsing-remitting MS (RRMS) remains a challenge, as conventional therapies, though beneficial, lack robust efficacy in relapse rate reduction. Anti-CD20 therapy with Ocrelizumab is effective but poses significant financial burden, especially in resource-limited settings like India. Rituximab, a well established drug with similar mechanism, remains unapproved for RRMS despite its potential benefits. Our study aims to establish efficacy (reduction in Annual Relapse Rate, ARR as primary end point) and safety of Rituximab in RRMS and explore endophenotype variations in MS pathogenesis to optimize therapeutic strategies. RRMS patients with pre-determined eligibility criteria will be recruited from multiple centres and randomized into either the conventional therapy arm (as per institute protocol) or the Rituximab arm. Patients will be monitored at baseline, 30 ±10 days, 90±10 days, 180± 10 days, 365± 10 days and then every 180 days (if no clinical deterioration occurs). Serum samples will be analysed for CD4, CD8, CD56 and cell clustering done to classify endophenotypes, along with individual HLA typing. miRNA profiling would also be performed. We anticipate establishing Rituximab as non-inferior to conventional therapies, with study outcomes guiding future official treatment guidelines. Creation of database for endophenotypic profile in India and incorporating the same in RRMS treatment could lead to improved patient prognostication and therapy selection, exemplifying precision medicine. The study attempts to identify epigenetic modifications by miRNA profiling in RRMS patients and assess correlation with endophenotype variants. |