Modify Clinical Study Protocol: CDSCO Panel Tells Roche On Multiple Sclerosis Drug Ocrelizumab
New Delhi: In response to the proposal presented by drug major Roche to conduct the Phase IV clinical trial for the drug product Ocrelizumab 300 mg Concentrate for solution for infusion 300 mg/10 mL (30 mg/mL) in a single-dose vial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has suggested the firm to modify the protocol and to submit the revised protocol for the further evaluation.
This came after the drug major Roche presented the protocol to conduct a Phase IV clinical trial for the drug product Ocrelizumab 300 mg Concentrate for solution for infusion 300 mg/10 mL (30 mg/mL) in a single-dose vial titled “A Multi-Center, Open-Label, Single Arm Phase IV Study to assess the safety and effectiveness of Ocrelizumab in Multiple Sclerosis (RMS and PPMS) patients in India (Overture)” vide protocol ML45008, Version 1.0 dated 12 Jul 2023.
Multiple sclerosis (MS) is a chronic condition that causes nerve damage. The four main types of MS are clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), primary-progressive MS (PPMS), and secondary-progressive MS (SPMS).
Relapsing-remitting multiple sclerosis (RRMS) is the most common course of MS. If one has RRMS, one will experience clearly defined attacks of new or increasing neurologic symptoms. These attacks — also called “relapses” or “exacerbations” — are followed by periods of partial or complete recovery (remissions). Primary progressive multiple sclerosis (PPMS) is a type of multiple sclerosis (MS) where symptoms get worse over time.
Ocrelizumab is a medication that treats multiple sclerosis. It works by slowing down an overactive immune system to prevent or delay symptoms. MS affects the central nervous system.
Ocrelizumab is a medication used in the management and treatment of primary progressive and relapsing multiple sclerosis. It is in the anti-CD20 monoclonal antibody class of medications.
Ocrelizumab is an anti-CD20 antibody that depletes circulating immature and mature B cells but spares CD20-negative plasma cells. The effector mechanisms of anti-CD20 antibodies are complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity.
At the recent SEC meeting for Neurology and Psychiatry held on 18th and 19th January 2023, the expert panel reviewed the protocol presented by drug major Roche for conducting the Phase IV clinical trial for drug product Ocrelizumab 300 mg Concentrate for a solution for infusion 300 mg/10 mL (30 mg/mL) in a single-dose vial.
After detailed deliberation, the committee recommended the following changes in the protocol:
1. Follow-up should be done for a minimum of 2 years.
2. The efficacy endpoint should be included as the co-primary objective of the study.
3. One Government independent site with a neurologist should evaluate the patients whether the patient is truly progressive for the PPMS before enrolment in the study.
4. A minimum of 10% of PPMS patients should be included in the study.
5. The number of evaluable patients in the study should be a minimum of 32.
6. The study sites should be geographically distributed.
Following the above, the expert panel suggested that the firm be required to submit a revised protocol to CDSCO for further evaluation before the committee.
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