Subjects with RR Multiple Sclerosis in whom intravenous immunoglobulin (IVIG) treatment is clinically indicated because first-line treatments are contraindicated or not tolerated.
Conditions
Interventions
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: eq
Sponsors
Octapharma AG
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): Heidelberg Assay Panel B-cell Antibody Response Panel Clinical Response: Relapse Activity, Disability Assessment;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). | — |
Countries
Austria
Outcome results
None listed