EUCTR2006-005270-47-LVActive, not recruitingNot Applicable
International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Bayer Schering Pharma AG
- Enrollment
- 1,880
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Completion of the BEYOND study 306440 as scheduled (i.e. no premature EOS in study 306440)
- •2. Relapsing multiple sclerosis (i.e. including SPMS with superimposed relapses)
- •3. Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
- •4. Females of child-bearing potential:
- •- Agreement to practice adequate contraception methods (intra-uterine contraceptive device [IUCD], condoms, oral contraceptives, or other adequate barrier contraception) and
- •- Negative pregnancy test (urine test and blood sampling for serum test at first visit)
- •- No lactation
- •5. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Serious or acute heart diseases such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
- •2. History of severe depression or suicide attempt, or current suicidal ideation
- •3. Epilepsy not adequately controlled by treatment
- •4. Known allergy to IFNs, to human albumin or to mannitol
- •5. The following pre-treatments within the specified time frames prior to study enrolment:
- •6 months before study entry:-Natalizumab (Tysabri)
- •3 months before study entry:
- •- Any other monoclonal antibody treatment
- •- Azathioprine
- •- Cyclophosphamide
- •- Cyclosporine A
- •- Cladribine
- •- Mitoxantrone
- •- Any other immuno-modulating or immuno-suppressive drugs including other recombinant or non-recombinant cytokines
- •Exceptions: IFNB 1b, glatarimer acetate, systemic corticosteroids, or ACTH
- •- Any other treatment known to be used for putative or experimental MS treatment (exceptions: statins for treatment of hypercholesterinemia or pentoxifylline).
- •6. Current or past (within the last 2 years) alcohol or drug abuse
- •7. Inability to administer subcutaneous injections either by self or by caregiver
- •8. Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Investigators
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International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-upRelapsing multiple sclerosisMedDRA version: 6.1Level: PTClassification code 10028245EUCTR2006-005270-47-ITSCHERING1,880