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

NCT05242133 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

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 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

Conditions

  • Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions

DRUG

Pegylated interferon beta-1a

Pegylated interferon beta-1a (CinnaGen) autoinjector (Physioject™),125 mcg, subcutaneous (SC) injection, every 2 weeks, for 24 months

DRUG

Interferon Beta-1A Prefilled Syringe

Interferon Beta-1A Prefilled Syringe, CinnoVex® (CinnaGen), 30 mcg, intramuscular injection, once a week, for 24 months

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2022-04-27
Completion
2022-04-27

Countries

  • Iran

Study Locations

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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 NCT05242133 on ClinicalTrials.gov