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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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11 February 2013 |
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Main ID: |
EUCTR2008-004579-22-DE |
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Date of registration:
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07/11/2008 |
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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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A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-cell/Antibody Response Panel to predict the clinical efefct of Octagam 5% in subjects with relapsing/remitting Multiple Sclerosis
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Scientific title:
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A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-cell/Antibody Response Panel to predict the clinical efefct of Octagam 5% in subjects with relapsing/remitting Multiple Sclerosis |
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Date of first enrolment:
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31/03/2009 |
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Target sample size:
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30 |
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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:2008-004579-22 |
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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: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Austria
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Subjects aged >= 18 years.
MS according to the revised McDonald criteria.
Relapsing-remitting form of MS.
First-line disease modifying treatments (with IFN-beta or glatiramer acetate) are contraindicated or not tolerated.
Kurtzke's EDSS between 0 and 3.5 (0 <= 3.5).
Subjects who experienced at least one relapse during the last 12 months or at least two relapses in the last 24 months prior to study entry.
Freely given, fully informed written consent obtained from subject.
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Subjects
- who have received treatment with immunoglobulins for any reason previously.
- who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids.
- who have received disease modifying first-line treatments with IFN-beta during the last 8 weeks or with glatiramer acetate during the last 16 weeks.
- who have received any monoclonal antibody therapies (e.g. natalizumab) previously.
- who had a relaspe within 3 months prior to study entry.
- with severe renal function impairment as defined by serum creatinine values > 24 mg/L.
- with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA.
- with a body weight > 120 kg.
- with a history of anaphylaxis after previous transfusions of blood or blood products.
- for whom MRI is contraindicated or who are allergic to gadolinium.
- being pregnant or lactating.
- who delivered a baby within 12 months before study entry (including miscarriage, stillbirth, abortion).
- with a diagnosis of severe depression.
- with known chronic infectious diseases or malignant disease.
- with known antibody deficiencies or other autoimmune diseases other than MS.
- participating in another study during the course of this study or during the past 6 months or who have ever participated in a study investigating in new disease modifying or immunosuppressive drugs.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.
MedDRA version: 9.1
Level: LLT
Classification code 10063399
Term: Relapsing-remitting multiple sclerosis
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Intervention(s)
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Trade Name: octagam
Product Name: Octagam 5%
Pharmaceutical Form: Intravenous infusion
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Primary Outcome(s)
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Main Objective: This is an exploratory trial to investigate
- whether any parameters of the Heidelberg Assay Panel (HAP) correlate with the clincial effect observed following Octagam 5% treatment in subjects with RR-MS.
- whether any parameters of the B-cell/Antibody Response Panel (BARP) correlate with the clinical effect observed following Octagam 5% treatment in subjects with RR-MS.
- the proportion of subjects clinically responding to Octagam 5% treatment vs. subjects not responding.
- the relapse activity during the study period.
- efficacy as assessed by neurological examinations using the Expanded Disability Status Scale (EDSS) and Functional System (FS) and the Multiple Sclerosis Functional Composite measure (MSFC).
- the change of T1- and T2-lesion load and Gd-enhancing lesion load as demonstrated by magnetic resonance imaging (MRI).
- the tolerability of Octagam 5% in subjects with RR-MS by monitoring safety parameters (vital signs, adverse events (AEs), safety laboratory tests.
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Primary end point(s): Heidelberg Assay Panel
B-cell/Antibody Response Panel
Clinical Response: Relapse activity, Disability assessment
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Secondary Objective:
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Secondary ID(s)
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2008-004579-22-AT
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57377482
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GAM-25
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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