Multiple Sclerosis. Disseminated Multiple Sclerosis
Conditions
Interventions
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 Republ
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, gene
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
Sponsors
Cinnagen Pharmaceutical Company
Vice chancellor for research ,Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: -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 .
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse Rate. Timepoint: Before intervention and every month after intervention. Method of measurement: Physical examination done by neurologist and EDSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Shiva Salami
Cinnagen Pharmaceutical Company
Outcome results
None listed