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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2006-005270-47-FI |
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Date of registration:
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19/12/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 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
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Scientific title:
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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 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 |
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Date of first enrolment:
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23/04/2007 |
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Target sample size:
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1880 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005270-47 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised:
Open: no
Single blind:
Double blind: no
Parallel group: no
Cross over:
Other: yes
Other trial design description: two consecutive phases A &B (A: 1 open group and 2 double blind groups and B: all 3 groups open)
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other: yes
Other specify the comparator: Phase A active controlled: IFNB-1b 500 µg versus IFNB-1b 250 µg
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Austria
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Belgium
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Finland
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France
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Germany
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Greece
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Hungary
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Ireland
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Italy
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Latvia
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Netherlands
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Slovenia
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Spain
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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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)
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- 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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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relapsing multiple sclerosis
MedDRA version: 9.1
Level: LLT
Classification code 10028245
Term: Multiple sclerosis
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Intervention(s)
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Trade Name: Betaferon 250µg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1b
CAS Number: L03 AB 08
Current Sponsor code: ZK 157046
Product Name: Betaferon 500µg
Product Code: ZK 157046
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1b
CAS Number: L03 AB 08
Current Sponsor code: ZK 157046
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Primary Outcome(s)
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Primary end point(s): The primary variables are the frequencies of the following events:
1. Flu-like-syndrome
This variable will consist of a combination of MedDRA terms indicative for this condition.
2. Injection site reactions
This variable will consist of a combination of MedDRA terms indicative for this condition.
3. Liver enzyme elevations
This variable will include all patients with an elevation of either AST/SGOT, or of ALT/SGPT, or of gammaGT, using the respective laboratory's upper limits of normal.
4. Hematological abnormalities
This variable will include all patients with decreased counts of white blood cells, platelets, neutrophil granulocytes, or lymphocytes, or a decreased hemoglobulin level, according to the respective laboratory's lower limits of normal.
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Main Objective: To increase the knowledge on the safety and tolerability profile of the IFNB-1b 500 µg dose
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Secondary Objective: To increase the knowledge on neutralizing activity to IFNB 1b and on patient-reported outcomes (PRO)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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