Multiple Sclerosis (MS). Demyelinating diseases of the central nervous system
Conditions
Interventions
Intervention 1: Intervention group: Ziferon 250 micrograms produced by Zistdaru Danesh (Iran), every other day subcutaneous injection for two years. Intervention 2: Control: Betaferon 250 micrograms p
Treatment - Drugs
Intervention group: Ziferon 250 micrograms produced by Zistdaru Danesh (Iran), every other day subcutaneous injection for two years.
Control: Betaferon 250 micrograms produced by Schering (Germany), every other day subcutaneous injection for two years.
Sponsors
Medical Vice chancellor for research, Tehran University of Science
Zist Daru Danesh Company
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Patients with Remitting -Relapsing Multiple Sclerosis (RRMS ) according to M.C. Donald criteria 2. Age between 18-50 years old 3. Expanded Disability Status Scale (EDSS) between 0-5.5 4. Completing informed consent 5. No relapse during last month 6. Negative pregnancy test 7. Having 2 attacks during last 2 years Exclusion Criteria 1. Pregnancy 2. Severe depression 3. History of suicide 4. Hypersensitivity to interferon beta preparations 5. Receiving IVIG (Intravenous Immunoglobulin) in the previous 6 months 6. History of plasma exchange in the last six months 7. History of interferon beta using in the previous six months 8. History of cytotoxic drug using in the previous six months 9. Impaired liver enzymes 10. Leukopenia 11. Non RRMS 12. Concomitant other autoimmune diseases 13. History of malignancy 14. Chronic liver disease except Gilbert 15. Chronic renal failure (Creatinine>1.1) 16. Claustrophobia 17. Sensitivity to Gadolinium 18. Participating in another trial 19. Nursing
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Relapses. Timepoint: Before the study and every three months after the start of the study. Method of measurement: Examining Patients.;Change in Disability. Timepoint: Before the study and every three months after the start of the study. Method of measurement: EDSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of new plaque and plaque enhancement in each group. Timepoint: Before the study and every six months after the start of the study. Method of measurement: MRI.;Neutralizing Antibody. Timepoint: Before the study and every six months after the start of the study. Method of measurement: cytopathic effect assay (CPE). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Reza Gheini
Tehran University of Medical Sciences
Outcome results
None listed