A prospective, multicentre, open label, exploratory study to investiga
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 multiple sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What it measured
Main measures
A panel of lab parameters (components of cells of the immune system, serum proteins, gene expression, single nucleotide polymorphism [SNP] analysis) will be analysed at baseline, 12 - 24 hours after end of the first infusion, and 24 and 48 weeks after the first Octagam® administration and the clinical course of the disease will be monitored by relapse activity, EDSS and Multiple Sclerosis Function
Disability progressionRelapsesImmune response
Other measures (1)
Lesion load in brain MRI imaging (T2 weighted, T1 weighted, Gd-enhancing lesion load) after treatment will be compared to lesion load before treatment.
MRI lesions
Who could take part
Relapsing MS · 18 and over · EDSS 0 to 3.5
Show the full criteria
Inclusion criteria
Inclusion: 1. Subjects aged greater than or equal to 18 years, either sex 2. Multiple sclerosis (MS) according to the revised McDonald criteria 3. Relapsing-remitting form of MS 4. First-line disease modifying treatments (interferon-beta [IFN-beta] or glatiramer acetate) are contraindicated or not tolerated 5. Kurtzke's Expanded Disability Status Scale (EDSS) between 0 and 3.5 (0 to less than 3.5) 6. 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 7. Freely given, fully informed written consent obtained from subject Exclusion: 1. Subjects who have received treatment with immunoglobulins for any reason previously 2. Subjects who have received immuno-suppressive treatments (e.g. azathioprine, mitoxantrone, cyclophosphamide) for any reason previously except relapse treatment with corticosteroids 3. Subjects 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 4. Subjects who have received any monoclonal antibody therapies (e.g. natalizumab) previously 5. Subjects who had a relapse within 3 months prior to study entry 6. Subjects with severe renal function impairment as defined by serum creatinine values greater than 24 mg/l 7. Subjects with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the subject has antibodies against IgA 8. Subjects with a body weight of greater than 120 kg 9. Subjects with a history of anaphylaxis after previous transfusions of blood or blood products 10. Subjects for whom magnetic resonance imaging (MRI) is contraindicated or who are allergic to gadolinium 11. Pregnant or lactating women 12. Subjects who delivered a baby within 12 months before study entry (including miscarriage and stillbirth) 13. Subjects with a diagnosis of significant depression 14. Subjects with known chronic infectious diseases or malignant disease 15. Subjects with known antibody deficiencies or other autoimmune diseases other than MS 16. 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Not provided at time of registration
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History
Started
Mar 2009
Finished
Sept 2010