A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate Equivalency of the Efficacy and Safety of Ocrelizumab (CinnaGen, Iran) in Comparison to Reference Product, Ocrevus® (Roche, Switzerland) in Patients With Relapsing Multiple Sclerosis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Cinnagen
- Enrollment
- 170
- Locations
- 15
- Primary Endpoint
- Annualized Relapse Rate at 48 weeks
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting multiple sclerosis (RRMS).
All the participants will receive one of the following regimens:
Ocrelizumab (CinnaGen) or Ocrevus® (Roche, Switzerland) ,600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks.
The primary objective of this study is to verify the equivalency of Ocrelizumab (CinnaGen) versus Ocrevus® (Roche, Switzerland) in reducing the annualized relapse rate (ARR) in participants with relapsing remitting multiple sclerosis (RRMS) at 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments.
- •Ages 18-55 years at screening, inclusive.
- •Diagnosis of MS, in accordance with the revised McDonald criteria (2010).
- •At least two relapses having occurred within the past 2 years or one relapse within the past 12 months prior to screening.
- •Neurological stability for ≥ 30 days prior to both screening and baseline.
- •EDSS, at screening, from 0 to 5.5 inclusive.
- •Patients of reproductive potential must use reliable means of contraception.
Exclusion Criteria
- •Diagnosis of primary progressive MS.
- •Disease duration of more than 10 years in patients with an EDSS ≤ 2.0 at screening.
- •Inability to complete an MRI (contraindications for MRI include but are not restricted to claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc).
- •Known presence of other neurological disorders which may mimic MS including but not limited to: neuromeylitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders.
- •Pregnancy or lactation.
- •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
- •History or currently active primary or secondary immunodeficiency.
- •Lack of peripheral venous access.
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- •Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study such as Congestive heart failure (NYHA III or IV functional severity).
Outcomes
Primary Outcomes
Annualized Relapse Rate at 48 weeks
Time Frame: 48 weeks
Total number of confirmed relapses divided by the total number of days on study A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection
Secondary Outcomes
- Time to onset of sustained disability progression for at least 12 weeks(Baseline up to Week 96)
- Total number of new Gadolinium (Gd)-enhancing lesions as detected by brain MRI(Baseline up to Week 96)
- Proportion of relapse-free patients by 96 weeks(Week 96)
- Number of Participants With Adverse Events (AEs)(Baseline up to Week 96)
- Number of Participants With Infusion Related Reactions (IRRs)(Baseline up to Week 96)
- Time to onset of sustained disability progression for at least 24 weeks(Baseline up to Week 96)
- Change in total T2 lesion volume as detected by brain MRI from baseline to week 96(Baseline up to Week 96)
- Immunogenicity Assessment(Baseline up to Week 96)
- Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI(Baseline up to Week 96)