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IRCT201205221859N4 IRCT 2012-10-09 Cinnagen Pharmaceutical Company The Comparison of effects of Cinnaferon with Betaferon in Relapsing- Remitting Multiple Sclerosis The Comparison of clinical and side effects of Cinnaferon with Betaferon in patients with Relapsing- Remitting Multiple Sclerosis 2012-06-21 anticipated 76 Complete https://irct.ir/trial/1451 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization method and process: All patients fulfilling inclusion criteria - without any exclusion item – will enter one of two study arms, Cinnaferon Vs. Betaferon, via a permuted block method, after they sign an informed consent letter. Permuted block method will create randomized numbers, one for each patient, in order to divide them in two complete equal arms with randomized based selection. 3 Multiple Sclerosis. Intervention 1: Amp Cinnaferon ,chemical formulation beta interferon1-b, (250µgr / 8 mIU / day, subcutaneous, every other day) for 24 months ,made in Cinnagen Pharmaceutical company in Islamic Republic Of Iran, generic name Amp Cinnaferon. Intervention 2: Amp Betaferon ,chemical formulation beta interferon1-b, (250µgr / 8 mIU / day, subcutaneous , every other day)for 24 months, made in Bayer company in Germany, generic name Amp Betaferon.
public Dr Shiva Salami
No. 2, 7th Alley, Simay-e-Iran St, Shahrak-e-Qods
Tehran Iran (Islamic Republic of) 1466998741 +98 21 8856 1556 shiva.salami45@yahoo.com;salamis@cinnagen.com Cinnagen Pharmaceutical Company scientific Dr Mohammad Ali Sahraian
Sina Hospital,Hasan abad Sq. , Imam Khomeini St.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8571 msahrai@sina.tums.ac.ir Sina Hospital Iran (Islamic Republic of) -Inclusion criteria: 1. Patients with Relapsing- Remitting Multiple Sclerosis based on McDonald's Criteria 2.age between 18-50 years old 3. Expanded Disability Status Scale (EDSS) 0- 5.5 4. Negative pregnancy test at baseline 5. Patients without Relapse in one last month 6. Signing consent form. -Exclusion criteria: 1. Being pregnant during trial or intention to get pregnant in start of trial 2.Psychiatric disease or major depression 3.The history of suicide4. Allergy or hypersensitivity reaction to injected medication in the start of trial 5. Treatment with Intravenous immunoglobulin (IVIG) within six months prior to trial 6. The history of plasma exchange within 6 months prior to trial 7.Using cytotoxic medication within six months prior to trial 8. The history of using beta interferon within three months prior to trial 9.Impaired Liver Function Tests (more than 2times normal range) 10.Leukopenia (less than half of the normal range) 11. Other types of multiple sclerosis except relapsing- remitting type 12. Association with other autoimmune diseases 13. The history of malignancy 14 .The history of chronic liver disease except Gilbert's syndrome 15. The history of renal dysfunction with creatinine (Cr) more than 1.1mg/dl 16. Patients with the history of fear from Magnetic resonance Imaging (MRI)or Claustrophobia 17 .The history of sensitivity to Gadolinium (Gd) 18. Patient participation in another clinical trial at the same time 19. Breastfeeding . 18 years 50 years Both G35 Disseminated Multiple Sclerosis Treatment - Drugs Treatment - Drugs Amp Cinnaferon ,chemical formulation beta interferon1-b, (250µgr / 8 mIU / day, subcutaneous, every other day) for 24 months ,made in Cinnagen Pharmaceutical company in Islamic Republic Of Iran, generic name Amp Cinnaferon Amp Betaferon ,chemical formulation beta interferon1-b, (250µgr / 8 mIU / day, subcutaneous , every other day)for 24 months, made in Bayer company in Germany, generic name Amp Betaferon Relapse Rate. Timepoint: Before intervention and every month after intervention. Method of measurement: Physical examination done by neurologist and EDSS. EDSS Expanded Disability Status Scale. Timepoint: Before intervention and every month after intervention. Method of measurement: Physical examination done by neurologist based on revised Mc-Donald (2010). Number and size of plaques and their enhancement. Timepoint: Before intervention and every six months after intervention. Method of measurement: Magnetic resonance Imaging ( MRI ). Neutralizing Antibodies. Timepoint: Before intervention and every six months after intervention. Method of measurement: measurement in peripheral blood. Vice chancellor for research ,Tehran University of Medical Sciences Cinnagen Pharmaceutical Company Vice chancellor for research ,Tehran University of Medical Sciences Approved 2012-01-07 Tehran University of Medical Sciences Ethics Committee Vice chancellor for research ,Tehran University of Medical Sciences, Qods St, Keshavarz Blvd. Tehran Iran (Islamic Republic of)