Early relapsing multiple sclerosis (MS) Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Group 1: Pre-classified as responders, receives the investigational medicinal product (IMP), Octagam 5%, 0.6 g/kg, which is a human immunoglobulin (Ig) solution with 5% protein content. This is admini
Sponsors
Octapharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or above 2. Early diagnosis of the relapsing form of MS (= 5years) according to the revised McDonald criteria (1-3) 3. Patients who are at least 3 months on stable dosage of either IFN-ß sc or GA and who did not receive the other first-line therapy before 4. Kurtzke Expanded Disability Status Scale (EDSS) less or equal to 3.5 5. Patients who experienced at least one medically confirmed relapse during the last 12 months or at least two such relapses in the last 24 months prior to study entry (but not within 30 days between last steroid treatment of relapse and start of screening ); subjects who relapse during the screening phase can be re-screened, once the relapse has resolved but earliest 30 days after the end of relapse treatment with steroids) or at least 1 T1 Gd+ lesion at screening
Exclusion criteria
Exclusion criteria: 1. Patients who have received treatment with immunoglobulins for any reason in the last 6 months 2. Patients who have received immunosuppressive treatments (e.g., azathioprine, mitoxantrone, cyclophosphamide) for any reason, in the past 3. Treatment with steroids (oral or parenteral, long-term, i.e. 30 days or more, not intermittent or burst, daily, =0.15 mg of prednisone or equivalent/kg/day) except relapse treatment with corticosteroids 4. Patients who have received monoclonal antibody therapy with natalizumab in the last 12 months 5. Patients who have ever received monoclonal antibody therapy with alemtuzumab, daclizumab, or ocrelizumab 6. Patients with severe renal function impairment as defined by serum creatinine values >120 µmol/L 7. Patients with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency (when the patient has antibodies against IgA) 8. Patients with a body weight higher than or equal to120 kg 9. Patients with a history of anaphylaxis after previous transfusions of blood or blood products 10. Patients for whom MRI is contraindicated or who are allergic to gadolinium (not complete)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is superiority with regard to decreased Annualised Relapse Rate (ARR) of Octagam 5% treatment in patients pre-classified as predicted responders compared to predicted non-responders. Neurological monitoring at each visit and Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC) score at visits week 24, 52, 80, 104, 116 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ARR of Octagam 5% treatment compared to active control 2. ARR of comparator treatment compared between predicted responders and non-responders to Octagam 5% treatment 3. Compare ARR of predicted responder to Octagam 5% treatment with both IMP treatment arms combined 4. Percentage of actual responders and non-responders in the 21-month period between 3 months after the first study treatment (?run-in? phase) and the end of treatment period at month 24 | — |
Countries
Austria, Bulgaria, Germany, Hungary, Russian Federation
Outcome results
None listed