| CTRI Number |
CTRI/2025/11/097877 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In patients with multiple sclerosis. |
|
Scientific Title of Study
|
An international multicenter, randomized, double-blind, parallel-group study of the comparative pharmacokinetics, safety, and immunogenicity of MIT-004, a concentrate for preparing an infusion solution, 30 mg/ml in patients with multiple sclerosis. |
| Trial Acronym |
MIT-004 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MIT-005/1, Version 3.0, Date 22 Aug 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayali Sadgune |
| Designation |
Head Medical Affairs |
| Affiliation |
Mudra Clincare |
| Address |
A-227, Silver Springs, Department of medicine, Second floor, Room number 02, Taloja
Raigarh
MAHARASHTRA
410208
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
md@mudraclincare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayali Sadgune |
| Designation |
Head Medical Affairs |
| Affiliation |
Mudra Clincare |
| Address |
A-227, Silver Springs, Department of medicine, Second floor, Room number 02, Taloja
MAHARASHTRA
410208
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
md@mudraclincare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayali Sadgune |
| Designation |
Head Medical Affairs |
| Affiliation |
Mudra Clincare |
| Address |
A-227, Silver Springs, Department of medicine, Second floor, Room number 02, Taloja
MAHARASHTRA
410208
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
md@mudraclincare.com |
|
|
Source of Monetary or Material Support
|
| Mudra Clincare, A-227, Plot-06, Department Of medicine, Silver Springs, Taloja, Navi Mumbai-410208 |
|
|
Primary Sponsor
|
| Name |
"MEDICAL INNOVATIONS AND TECHNOLOGIES" (LLC "MIT") |
| Address |
43 BOLSHAYA SERPUKHOVSKAYA str., building 11, room 3, Podolsk, Moscow region, 142105 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mudra Clincare |
A-227, Plot-06, Department Of medicine, Silver Springs, Taloja, Navi Mumbai-410208 |
|
|
Countries of Recruitment
|
India
Russian Federation |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Mahajan |
Dr. Mahajan’s Multispecialty Hospital |
R-831, Department of Medicine, First Floor, Block 02, Thane Belapur Road, Navi Mumbai - 400708 Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA |
8291745386
mahajanhospital21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr. Mahajan’s Multispecialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G311||Senile degeneration of brain, notelsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MIT-004
(Ocrelizumab)
|
concentrate for preparing an infusion solution, 30 mg/ml in patients with multiple sclerosis |
| Comparator Agent |
Ocrevus (Ocrelizumab)
|
concentrate for preparing an infusion solution, 30 mg/ml in patients with multiple sclerosis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Signed and dated Informed Consent of the patient to participate in the study
2.Male and female patients aged 18-55 years old
3.Diagnosis of multiple sclerosis established according to the McDonald criteria (2017)
4.Presence of a relapsing form of multiple sclerosis with active disease.
5.Patients recommended for starting ocrelizumab therapy and who have not previously received ocrelizumab
6.Patients EDSS severity 0-5.5 points
7.Compliance with established contraception rules
|
|
| ExclusionCriteria |
| Details |
1.Withdrawal of informed consent by the patient
2.The Investigator decided that the patient should be excluded in the best interests of the patient himself
3.The patient has experienced an undesirable phenomenon or a serious undesirable phenomenon, which, in the investigators opinion, makes it dangerous for the patient to continue participating in the study
4.Patients failure to comply with the rules of participation in the study.
5.The patient was included in violation of the inclusion/non-inclusion criteria of the protocol
6.The need to prescribe therapy prohibited by the Study Protocol
7.Pregnancy of the study participant
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Area under the concentration–time curve after Infusion 1 (Day 1–15) and Infusion 2 (Day 15–141) |
Day 1 - before the infusion, 0.5 h, 1.5 h, 3 h, 6 h, 12 h after the start of the infusion, Day 2 – 24 hours after the start of the infusion, Days 3 (48h), 4 (72h), 5 (96h), 7 (144 h), 9 (192h), 12 (264h), 15 (336h) (before infusion 2). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Immunogenicity
assessment determining binding and neutralizing antibodies
to ocrelizumab |
visit 9, visit 25 compared to the data obtained at visit
1. |
| Pharmacodynamic assessment Dynamics of CD19 levels |
visits 9 and 25 compared to data obtained
at visit 0 (Screening visit) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="132"
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)
|
25/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mudraclincare@gmail.com].
- For how long will this data be available start date provided 30-12-2025 and end date provided 10-10-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Multiple sclerosis (MS) is a chronic neurological condition characterized by a focal and diffuse
autoimmune inflammatory process, demyelination, and neurodegeneration in the central nervous
system with high clinical and pathological heterogeneity. Depletion of the B-cell pool plays an
important role in suppressing inflammation in MS. B lymphocytes are involved in the pathogenesis
of MS, as they can secrete cytokines, selectively present antigens to T cells and produce antibodies
together with plasma cells, and meningeal lymphoid follicles can be
associated with cortical demyelination and axon loss.
At the same time, B cells are involved in cell growth, remodeling and repair. Moreover, regulatory
B cells play an important role in fighting excessive inflammation.
Therapeutic monoclonal antibodies are playing an increasingly important role in the treatment of
MS, being one of the most effective therapies available. One of the promising monoclonal anti
bodies is ocrelizumab, a molecule of which is derived from a mouse anti-CD20 antibody and hu
manized by recombination methods. Ocrelizumab’s IgG1 tail is capable of binding to a specific
CD20 epitope. The target molecule (CD20) is a glycosylated phosphoprotein that is expressed in
the vast majority of B lymphocyte lines: pre-B cells, mature and immature B cells, and memory
cells. As a result of exposure to ocrelizumab, the B cell population decreases by three main mech
anisms: antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, and apop
tosis. In addition, ocrelizumab also acts on a subtype of circulating T cells that express CD20,
which accounts for ~6% of the total number of T cells. |