Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple Sclerosis

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2022
The purpose of this study is to evaluate the efficacy and safety of peginterferon beta-1a produced by CinnaGen compared with CinnoVex® (CinnaGen) in subjects with relapsing remitting multiple sclerosis (RRMS). All the participants will receive one of the following regimens: pegylated interferon beta-1a (CinnaGen), autoinjector (Physioject™), 125mcg, subcutaneous, every 2 weeks for 24 months or CinnoVex® (CinnaGen), prefilled syringes, 30mcg, intramuscular, once a week for 24 months. The primary objective of this study is to verify the non-inferiority of peginterferon beta-1a (CinnaGen) versus CinnoVex® (CinnaGen) in reducing the annualized relapse rate (ARR) in participants with relapsing remitting multiple sclerosis (RRMS) at 2 years. The secondary objectives of this study are: * Reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans * Slowing the progression of disability * Comparing adverse events
Epistemonikos ID: 5a457aab1808035f1815f13b89781ee0ed3a2464
First added on: Mar 31, 2022