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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
170
Ocrelizumab (CinnaGen, Iran) will be administered via intravenous (IV) infusion.
Ocrelizumab (Roche, Switzerland) will be administered via intravenous (IV) infusion.
Qaem International Hospital
Rasht, Gilan Province, Iran
Golestan Hospital
Ahvāz, Khozestan, Iran
Bouali Hospital, MS Clinic
Sari, Mazandaran, Iran
Qaem Hospital
Mashhad, Razavi Khorasan Province, Iran
Sina Hospital
Hamadan, Iran
Ayatollah Kashani Hospital, MS Clinic
Isfahan, Iran
Shafa Hospital
Kerman, Iran
Imam Reza Hospital
Kermanshah, Iran
Dr. Nikseresht's office
Shiraz, Iran
Namazi Hospital
Shiraz, Iran
...and 5 more locations
Annualized Relapse Rate at 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
Time frame: 48 weeks
Time to onset of sustained disability progression for at least 12 weeks
Disability progression is defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) At least a 1.5-point increase in patients with a baseline score of 0 B) At least a 1.0-point increase on the EDSS in patients with a baseline score of 0\<EDSS≤5.5 C) At least a 0.5-point increase on the EDSS in patients with a baseline score of \>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis)
Time frame: Baseline up to Week 96
Time to onset of sustained disability progression for at least 24 weeks
Disability progression is defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) At least a 1.5-point increase in patients with a baseline score of 0 B) At least a 1.0-point increase on the EDSS in patients with a baseline score of 0\<EDSS≤5.5 C) At least a 0.5-point increase on the EDSS in patients with a baseline score of \>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis)
Time frame: Baseline up to Week 96
Proportion of relapse-free patients by 96 weeks
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
Time frame: Week 96
Total number of new Gadolinium (Gd)-enhancing lesions as detected by brain MRI
Sum of the individual number of (Gd)-enhancing lesions at Weeks 24, 48, and 96
Time frame: Baseline up to Week 96
Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI
Sum of the individual number of new, and/or enlarging T2 hyperintense lesions at Weeks 24, 48, and 96
Time frame: Baseline up to Week 96
Change in total T2 lesion volume as detected by brain MRI from baseline to week 96
Time frame: Baseline up to Week 96
Number of Participants With Adverse Events (AEs)
Intensity, seriousness and causality assessment of observed AEs, and abnormal laboratory findings every 12 weeks.
Time frame: Baseline up to Week 96
Number of Participants With Infusion Related Reactions (IRRs)
Assessment of IRRs every 24 weeks
Time frame: Baseline up to Week 96
Immunogenicity Assessment
Number of participants positive for anti-drug antibodies at weeks 24, 48 and 96
Time frame: Baseline up to Week 96
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