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IRCT201612306135N8 IRCT 2017-01-14 CinnaGen Pharmaceutical Company Efficacy and safety of peginterferon beta-1a (CinnaGen) in relapsing-remitting multiple sclerosis patients. 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. 2018-03-15 anticipated 168 Complete https://irct.ir/trial/6574 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patient randomization process will be centrally conducted by simple randomization method (complete algorithm) in PASS software for a total of 168 patients (with a 1: 1 allocation ratio). After the randomization procedure, a code will be allocated to each patient that will be used as patient identifier throughout the study. The code will consist of four numbers (corresponding to the randomization number), 4 initials (corresponding to the first two letters of first name, first two letters of surname), and 3 numbers (center code), e.g. ABCD001PE3-0001. Randomization numbers will be determined sequentially. 3 Multiple sclerosis. 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. Intervention 2: Intervention group 2: CinnoVex® (CinnaGen) 30 mcg, prefilled syringe, injected intramuscularly once a week for 96 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is All research data belong to the CinnaGen research and production company. Once approved by the Food and Drug Administration, in case of discretion, it will be published at the appropriate time.
public Dr.somayeh Amini
No 2, Emad khorasani, Derakhti St., Dadman Bul., Shahrak Gharb, Tehran, Iran.
Tehran Iran (Islamic Republic of) 146699874 0098 21 43473000; 0098 21 88562862; 0098 21 88076438 amini.s@orchidpharmed.com Orchidpharmed company scientific Dr. Somayeh Amini
No 2, Emad khorasani, Derakhti St., Dadman Bul., Shahrak Gharb, Tehran, Iran.
Tehran Iran (Islamic Republic of) 146699874 0098 2143473000; 0098 21 88562862; 0098 21 88076438 amini.s@orchidpharmed.com Orchidpharmed company Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 50 years Both 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 G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs 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 Intervention group 2: CinnoVex® (CinnaGen) 30 mcg, prefilled syringe, injected intramuscularly once a week for 96 weeks 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. 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. CinnaGen Pharmaceutical Company Approved 2016-11-05 Tehran University of Medical Sciences TUMS Ethic Committee, 6th floor, Central Building, Ghods st, Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of) Approved 2016-10-17 Tabriz University of Medical Sciences Vice, Chancellor of Research Affairs, 3rd Floor, No 2 Central Building, Golgasht Ave., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)