]>
IRCT2013030512398N3 IRCT 2014-03-04 Biosun Pharmed Company The Effectiveness, Safety and Tolerability of Actorif® Compared to Rebif® in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) A Randomized, Double-blind Controlled Study to Determine the Effectiveness, Safety and Tolerability of Actorif® Compared to Rebif® in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) 2011-10-21 anticipated 144 Complete https://irct.ir/trial/12463 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Multiple sclerosis. Intervention 1: Group A (Intervention): They get Actorif (Interferon beta-1a) 44mcg/0.5ml in prefilled syringes, Supplied by Actover/Amegabiotech. It will be administered 3 times a week subcutaneously. Intervention 2: Group B (Control) : They get Rebif (Interferon beta-1a) beta -1a 44mcg/0.5ml in prefilled syringes, Supplied by Merck Serono .It will be administered 3 times a week subcutaneously.
public Farhad Hatami Sadabadi (MD)
No.17, Dashte Behesht Ave,Saadat abad Ave,Tehran,Iran
Tehran Iran (Islamic Republic of) +98 21 2206 9696 Farhad.hatami@actoverco.com Actover Pharmaceutical Company scientific Seyed Massood Nabavi (MD)
Mostafa Khomeini Hospital, Italia St.,Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8800 3134 Massoodnabavi@yahoo.com Shahed University,Medical University,Nourolgy department Iran (Islamic Republic of) Inclusion Criteria: Male or female patients aged between 18-55 years, with a diagnosis of RRMS based on McDonald criteria 2010and or have two relapses in previous two years, and are eligible for interferon beta 1a therapy according to indications and clinical use in the product monograph; Patients must have an EDSS score of 0.0 to 5.5;Patients must have at least 2 relapses in previous 2 years; Signed informed consent obtained prior to initiation the study; Patients do not have any condition that mandates excluding them from the study; Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the Investigator for four weeks prior to the study and during the study. For the purposes of this study, child-bearing potential is defined as: “All female patients unless they are post-menopausal for at least one year or are surgically sterile”; Ability to co-operate with the treatment and follow up. Exclusion Criteria Disease-dependent criteria(Participant has an ongoing MS relapse; Has any progressive form of MS;Presenting MS relapse within 30 days prior to study drug administration); Safety of treatment dependent criteria: Presence of any serious concomitant systemic disorders incompatible with the administration of interferon beta-1a or any systemic disease that can influence the patient's safety(history of hypersensitivity to natural or recombinant interferon beta-1a, or hypersensitivity to human albumin or any other component of the formulation; History of uncontrolled seizures within the 3 months prior to enrollment; History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment; Serious local infection or systemic infection within 8 weeks prior to enrollment; Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception; History of major depression; History of major cardiac disease; History of known malignancy(except: S.C.C,B.C.C, non melanoma) or patient who is under chemotherapy); Patients with inadequate organ function(Bone Marrow: absolute neutrophil count (ANC) ≤ 1.5 x 109/L, platelet count ≤100 x 109/L,Hemoglobin ≤ 9 g/dL; Hepatic: Bilirubin ≥ 1.5 x the upper limit of normal (ULN),aspartate transaminases (AST/SGOT) And/or alkaline transaminases(ALT/SGPT)≥2.5xULN,alkaline phosphatase (AP)≥2.5 x ULN; Renal: Serum creatinine ≥1.5 mg/dL or creatinine clearance ≤ 60 mL/min calculated according to the Cockroft and Gault formula); Criteria dependent on compliance with study procedures, or the evaluation of the disability(Unwilling to use a reliable and acceptable contraceptive method throughout the study period;Conditions interfering with Magnetic Resonance Imaging (MRI) or Gadolinium DTPA (Gadovist, contrast agent) allergy or Inability to undergo MRI with gadolinium administration;Treatment with certain other agents to treat MS underlying disease; Participant received any other approved disease modifying therapy for MS (e.g. glatiramer acetate IV, Immunoglobulin, Azathriopine, Methotrexate, Cyclophosphamide, Mitoxantrona, Plasmapheresis) or any cytokine or anti-cytokine therapy within the 3 months prior to Study Day 0 (SD0);Systemic corticosteroids within 30 days prior to the initiation of this study treatment;Treatment with any investigational product within 30 days prior to study drug administration; Previous participation in this study.) 18 years 55 years Both G35 Demyelinating diseases of the central nervous system Treatment - Drugs Treatment - Drugs Group A (Intervention): They get Actorif (Interferon beta-1a) 44mcg/0.5ml in prefilled syringes, Supplied by Actover/Amegabiotech. It will be administered 3 times a week subcutaneously. Group B (Control) : They get Rebif (Interferon beta-1a) beta -1a 44mcg/0.5ml in prefilled syringes, Supplied by Merck Serono .It will be administered 3 times a week subcutaneously. Safety outcome :Prevalence of Flu like Syndrome. Timepoint: At 6th,12th months after initial treatmen. Method of measurement: The Frequency of Flu like syndrom. Effectiveness outcome: The proportion of Relapse. Timepoint: At 6th,12th months after initial treatment. Method of measurement: The frequency of relapse (Clinical,MRI). Tolerability outcome: The prevalence of Heacache. Timepoint: At 6th,12th months after initial treatment. Method of measurement: The Frequency of headache. Effectiveness outcome: Proportion of progression. Timepoint: At 3th, 6th,12th months after initial treatment. Method of measurement: The frequency of progression(Clinical,EDSS, MRI). Safety outcome: Prevalence of Injection site reaction. Timepoint: At 6th,12th months after initial treatment. Method of measurement: The frequency of injection site reaction. Safety outcome: Prevalence of Laboratory abnormalities. Timepoint: At 6th,12th months after initial treatment. Method of measurement: The frequency laboratory abnormalities( LFT,leukopenia). Tolerability outcome: The prevalence of AEs. Timepoint: At 6th,12th months after initial treatment. Method of measurement: The frequency of AEs(Vomiting,Nausea). Biosun Pharmed Company Approved 2013-03-06 Vice chancellor of Shahed Medical University,Neurology department Shahed University,apposite of the Emam Khomeini Shrine,Tehran-Ghom free way,Tehran,Iran Tehran Iran (Islamic Republic of)