Comparison of Ziferon and Betaferon in multiple sclerosis management

Phase 3

• Conditions: Multiple Sclerosis (MS).; Demyelinating diseases of the central nervous system

• Registration Number: IRCT138806102397N1
• Lead Sponsor: Medical Vice chancellor for research, Tehran University of Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber 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 Outcome Measures

Name	Time	Method
umber 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).