Efficacy and safety of peginterferon beta-1a (CinnaGen) in relapsing-remitting multiple sclerosis patients

INTERVENTION: Intervention 1: Pegylated interferon beta‐1a (CinnaGen) autoinjector (Physioject™) for patients with dose of 125micrograms, subcutaneous (S/C) injection every 2weeks for 24 months. Intervention 2: CinnoVex® (CinnaGen) 30 mcg, prefilled syringe, injected intramuscularly once a week for 24 months. CONDITION: Multiple sclerosis. ; Multiple sclerosis PRIMARY OUTCOME: Annual relapse rate. Timepoint: Ralapse rate counts during 24 months/ monthly visits. Method of measurement: A relapse is defined as an episode of neurological symptoms that happens at least 30 days after any previous episode began, lasts at least 24 h and is not attributable to another cause and occurs in the absence of an infection or fever. SECONDARY OUTCOME: Any ‐ Adverse events (AEs), Adverse drug reactions (ADR) including: o Flu‐like symptoms, injection site reaction (redness, pain, itching, necrosis), o Rising AST, ALT or ALP 2.5 times more than normal value,or Hyperbilirubinemia: 1.5 Times more than Upper normal limit, Leukopenia (WBC <3000), Thrombocytopenia (Platelet count < 100,000),. Timepoint: During 24 months of study follow up. Method of measurement: Clinical and laboratory evaluation. Gadolinium‐enhancing lesions, New active lesions (T2), Volume of new or newly enlarging T2 hyperintense, gadolinium‐enhancing, and T1 hypointense lesions, brain atrophy. Timepoint: 6th , 12th, 24th month. Method of measurement: MRI evaluation. Number of new or newly enlarging hyperintense lesions on T2‐weighted images (relative to baseline MRI). Timepoint: Baseline, 6th , 12th, 24th month. Method of measurement: MRI evaluation. Proportion of patients with 12 weeks of sustained disability progression. Timepoint: During 24 months of study follow up. Method of measurement: Clinical evaluation. INCLUSION CRITERIA: Age 18‐50 years Relapsing‐remitting multiple sclerosis (McDonald criteria 2010) Expanded Disability Status Scale 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 Lactating women or women who tend to be pregnant