Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Octagam® 5% (12 infusions 0.4 g/kg every 4 weeks).
Sponsors
Octapharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Functional Composite (MSFC) at predefined time points. Statistical analysis will test whether any of the lab parameters of the HAP panel or the B-cell antibody response panel might be able to predict the clinical outcome observed following Octagam® 5% treatment. The proportion of subjects clinically responding to Octagam® 5% will be determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lesion load in brain MRI imaging (T2 weighted, T1 weighted, Gd-enhancing lesion load) after treatment will be compared to lesion load before treatment. | — |
Countries
Austria, Germany
Outcome results
None listed