Multiple sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group 1: Pegylated interferon beta-1a (CinnaGen) autoinjector (Physioject™) for patients with dose of 125micrograms, subcutaneous (S/C) injection every 2weeks for 96 weeks
Sponsors
CinnaGen Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of new or newly enlarging hyperintense lesions on T2-weighted images (relative to baseline MRI). Timepoint: Baseline, 24th, 48th, 96th week. Method of measurement: MRI evaluation.;Proportion of patients with 12 weeks of sustained disability progression. Timepoint: During 96 weeks of study follow up. Method of measurement: Clinical 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: 24th, 48th, 96th week. Method of measurement: MRI evaluation.;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 96 weeks of study follow up. Method of measurement: Clinical and laboratory evaluation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.somayeh Amini
Orchidpharmed company
Outcome results
None listed