Efficacy and safety of peginterferon beta-1a (CinnaGen) versus CinnoVex® (CinnaGen) in reducing the annualized relapse rate (ARR) in participants with relapsing-remitting multiple sclerosis: A phase III, randomized, parallel, non-inferiority study.

Inclusion criteria:

Age 18-50 years Relapsing-remitting multiple sclerosis (RRMS) (McDonald criteria 2010) Expanded Disability Status Scale (EDSS) is 0–5 At least one relapse having occurred within the past 12 months Subjects have refused alternative treatments and other available therapies Ability to understand the purpose and risks of the study and provide signed and dated an informed consent Negative pregnancy test for childbearing women

Exclusion criteria:

Primary progressive, secondary progressive, or progressive- relapsing MS Female subjects considering becoming pregnant while in the study or currently breastfeeding Subjects for whom MRI was contraindicated, i.e., who had pacemakers or were allergic to gadolinium,... Unwillingness or inability to comply with the requirements of the protocol Pre-specified laboratory abnormalities History of any clinically significant that would preclude participation in a clinical trial History of malignant disease (with the exception of squamous cell carcinomas of the skin that are cured) History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline History of suicidal ideation or an episode of severe depression within 3 months prior to Baseline Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) greater than 2 times the upper limit of normal Bilirubin greater than 1.5 times the upper limit of normal Total white blood cell count (WBC) <4000 /mm3 Absolute Neutrophil Count (ANC) of < 1500 /mm3 Platelet count <120,000 c/mm3 Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects Serum creatinine upper limit of normal lab value An MS relapse that has occurred within the 30 days prior to randomization or the subject has not stabilized from a previous relapse prior Elective surgery performed from 2 weeks prior or scheduled through the end of the study Any prior treatment with Total Lymphoid Irradiation, Cladribine, T-cell Vaccine, Natalizumab, Rituximab, BIIB017, Fingolimod, Dimethyl fumarate, and Teriflunomide Prior treatment within 1 with Cyclophosphamide– Mitoxantrone Prior treatment within 6 months with Cyclosporine, Plasma exchange, Intravenous immunoglobulin (IVIG), Azathioprine, Methotrexate Any prior treatment within 6 months with interferon Prior treatment within 30 days prior with Systemic Corticosteroids Prior treatment with Glatiramer Acetate within 4 weeks prior to randomization Treatment with another investigational drug within the 6 months prior to randomization Other reasons, that in the opinion of the investigator, made the subject unsuitable for enrolment

Target sample size: 168