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

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 168

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-speci?ed 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annual relapse rate. Timepoint: Ralapse rate counts during 96 weeks/ every 4 weeks 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 Measures