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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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