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

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.

Timeline

Start

2019-08-19

Primary completion

2020-11-09

Completion

2021-10-01

Publications

• Sahraian MA, Abolfazli R, Shaygannejad V, Ashtari F, Majdinasab N, Navardi S, Baghbanian SM, Sedighi B, Naser Moghadasi A, Nahayati MA, Ghalyanchi Langroodi H, Mohammadianinejad SE, Beladi Moghadam N, Ayromlou H, Nikseresht A, Ghiasian M, Razazian N, Asadollahzadeh E, Sabzvari A, Kafi H, Albooyeh S. Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial. Sci Rep. 2024 Oct 22;14(1):24921. doi: 10.1038/s41598-024-75745-y.

Drugs

Indications