E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Heidelberg Assay Panel B-cell/Antibody Response Panel Clinical Response: Relapse activity, Disability assessment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 34 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 34 |