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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.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2008-004579-22-AT
Date of registration: 15/09/2008
Prospective Registration: Yes
Primary sponsor: Octapharma AG
Public title: 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 effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)
Scientific title: 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 effect of Octagam 5% in subjects with relapsing/remitting (RR) multiple sclerosis (MS)
Date of first enrolment: 14/10/2008
Target sample size: 30
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004579-22
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Austria
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
·Subjects aged = 18 years.
MS according to the revised McDonald criteria.
Relapsing-remitting form of MS.
First-line disease modifying treatments (IFN-beta or glatiramer acetate) are contraindicated or not tolerated.
Kurtzke’s EDSS between 0 and 3.5 (0 to <= 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.
Subjects who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids.
Subjects who have received disease modifying first-line treatments treatment with IFN-beta during the last 8 weeks or with glatiramer acetate during the last 16 weeks.
Subjects who have received any monoclonal antibody therapies (e.g. natalizumab) previously.
Subjects who had a relapse within 3 months prior to study entry.
Subjects with severe renal function impairment as defined by serum creatinine values > 24 mg/L.
Subjects with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA.
Subjects with a body weight of >120 kg.
Subjects with a history of anaphylaxis after previous transfusions of blood or blood products.
Subjects for whom MRI is contraindicated or who are allergic to gadolinium. Pregnant or lactating women.
Subjects who delivered a baby within 12 months before study entry (including miscarriage and stillbirth).
Subjects with a diagnosis of significant depression.
Subjects with known chronic infectious diseases or malignant disease.· Subjects with known antibody deficiencies or other autoimmune diseases other than MS.Subjects 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
Health Condition(s) or Problem(s) studied
Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.
Intervention(s)

Trade Name: Octagam 5%
Product Name: Octagam 5%
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Immunoglobulin
CAS Number: 9007-83-4
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)
Main Objective: To investigate whether any parameters of the HAP correlate with the clinical effect observed following Octagam 5% treatment in subjects with RR MS.
To investigate whether any B-cell/antibody responses correlate with the clinical effect observed following Octagam 5% treatment in subjects with RR MS.
To investigate the proportion of subjects responding to Octagam 5% treatment vs. subjects not responding.
To investigate the relapse activity during the observation period.
To investigate 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).
To investigate the change of T2/T1 lesion load and active lesions as demonstrated by contrast enhancement on magnetic resonance imaging (MRI).
To investigate the tolerability of Octagam 5% in subjects with RR MS by monitoring safety parameters (vital signs, adverse events (AEs), safety laboratory tests).
Primary end point(s): Heidelberg Assay Panel
B-cell Antibody Response Panel
Clinical Response: Relapse Activity, Disability Assessment
Secondary Objective:
Secondary Outcome(s)
Secondary ID(s)
GAM-25
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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