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Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis

NCT04966338 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-10-18

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Ocrelizumab (CinnaGen, Iran)

Ocrelizumab (CinnaGen, Iran) will be administered via intravenous (IV) infusion.

BIOLOGICAL

Ocrelizumab (Roche, Switzerland)

Ocrelizumab (Roche, Switzerland) will be administered via intravenous (IV) infusion.

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Principal Investigators

  • Mohammad Ali Sahraian, professor · Neurologist/MS Research Center, Neuroscience Institute ,Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2020-11-09
Completion
2021-10-01

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04966338 on ClinicalTrials.gov