Status:
COMPLETED
Optimizing IFN Beta - 1B Dose
Lead Sponsor:
University of Turin, Italy
Collaborating Sponsors:
Dimensione Ricerca s.r.l.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
BetaferonR is effective in reducing relapse rate and MRI T2-weighted lesion frequency in MS patients at the dose of 8 MIU on alternate days (THE IFNB MS Study Group, 1993). Relapse rate is reduced by ...
Detailed Description
Comparing the frequency of new Gd enhancing lesions in a group of patients presenting a residual MRI activity during the last four months of the six month standard dose (8MIU) Betaferon treatment rand...
Eligibility Criteria
Inclusion
- Written informed consent obtained.
- Age between 18 and 50 years inclusive.
- Male and female patients.
- Clinically definite or laboratory supported definite RR MS (Poser et al, 1983) for not less than 2 year.
- Two clinically documented relapses during the preceding 24 months.
- No relapse or relapse related neurological deterioration for at least 30 days prior to entry in the study.
- Patients EDSS score from 1 to 3.5 (probably to be extended to 5.5).
- MRI activity. At least one enhancing lesion during the baseline MRI run-in study .
- Women capable of having children must agree to use adequate con-traceptive methods (condoms with spermicides, IUCD, oral contraceptives or other adequate barrier contraception).
- Caregivers agreement to assist the patient to comply with study requirements, if neces-sary (e.g. study drug administration, visits to center).
Exclusion
- Any form of Multiple Sclerosis other than relapsing-remitting.
- Any other disease which could better explain the patient's signs and symptoms.
- Any other disabling condition, which could interfere with the clinical evaluation.
- Pregnancy or lactation.
- Medical psychiatric, or other conditions that compromise patient's ability to give informed consent, to comply with the trial protocol, or to complete the study.
- Alcohol or drug abuse in the 90 days preceding screening visit.
- Uncontrolled clinically significant heart diseases, i.e., cardiac arrhythmias, uncon-trolled angina pectoris, uncompensated congestive heart failure
- Clinically significant liver, renal and bone marrow dysfunction as defined by the ran-ges of laboratory evaluations. The following ranges (see table 1) for key laboratory evaluations will be considered as adequate for inclusion:
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00473213
Start Date
September 1 1999
End Date
February 1 2004
Last Update
May 14 2007
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