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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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7 September 2021 |
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Main ID: |
EUCTR2004-003799-13-ES |
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Date of registration:
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04/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS
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Scientific title:
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A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS |
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Date of first enrolment:
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17/02/2005 |
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Target sample size:
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230 |
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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:2004-003799-13 |
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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: no
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Historical data
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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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Denmark
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Ireland
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Lithuania
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Spain
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Subject has a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria (31).
2. Subject is eligible for interferon therapy.
3. Subject is between 18 and 60 years old.
4. Subject has an EDSS <6.0.
5. Subject is willing to follow study procedures.
6. Subject has given written informed consent.
7. Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
· Being post-menopausal or surgically sterile, or
· Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study.
Confirmation that the subject is not pregnant must be established by a negative serum or urinary hCG test within 7 days prior to start of study treatment. A pregnancy test is not required if the subject is post-menopausal or surgically sterile.
Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Subject has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
2. Subject had any prior interferon beta therapy (either beta-1b or beta-1a)
3. Subject has an ongoing MS relapse.
4. Subject received any other approved disease modifying therapy for MS (e.g. glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to SD1.
5. Subject had prior use of cladribine or has previously received total lymphoid irradiation.
6. Subject received oral or systemic corticosteroids or ACTH within 30 days of SD1.
7. Subject received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1.
8. Subject received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath) within the 12 months prior to SD1.
9. Subject requires chronic or monthly pulse corticosteroids during the study.
10. Subject received any investigational drug or experimental procedure within 12 weeks of SD1.
11. Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values
12. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
13. Subject suffers from current autoimmune disease.
14. Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol.
15. Subject has a known allergy to IFN or the excipient(s).
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 form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0
Level: PT
Classification code 10028245
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Intervention(s)
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Trade Name: Rebif
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon-beta-1a
CAS Number: 9008-11-1
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
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Primary Outcome(s)
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Main Objective: The primary objective of the study is to compare the antigenicity of the new FBS-free/HSA-free Rebif® formulation (RNF) to historical data
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Secondary Objective: - To examine the time course of NAb development in subjects with relapsing forms of MS newly exposed to RNF.
- To determine if pre-existing factors affect NAb development through collection of baseline subject demographic data and disease characteristics.
- To determine the overall safety of RNF compared to the known safety profile of the current formulation of Rebif.
- To describe changes in PD markers.
- To assess the clinical status of subjects throughout the study by assessing EDSS and collecting documentation on relapses.
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Primary end point(s): The primary endpoint is the proportion of subjects that are NAb positive at the Week 96 visit.
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Secondary ID(s)
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25632
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2004-003799-13-SE
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Not applicable
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 03/02/2005
Contact:
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