relapsing multiple sclerosis MedDRA version: 18.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Octagam 50 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin
CAS Number: 308067-58-5
Current Sponsor code: Octagam 5%
Other descriptive nam
Sponsors
Octapharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged =18 years 2) Early diagnosed 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’s EDSS =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 6) Voluntarily given, fully informed written consent obtained from patient before any study-related procedures are conducted 7) Patient must be capable to understand and comply with the relevant aspects of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 211 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
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 such as azathioprine, mitoxantrone, cyclophosphamide, teriflunomide or fingolimod in the last 6 months 3) Patients who have received rituximab or other immune cell depleting therapies in the last 18 months 4) 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 5) Patients who have received monoclonal antibody therapy with natalizumab in the last 12 months 6) Patients who have ever received monoclonal antibody therapies with alemtuzumab, daclizumab, or ocrelizumab 7) Patients with severe renal function impairment as defined by serum creatinine values >120 µmol/L 8) Patients with known intolerance to homologous immunoglobulins, especially immunoglobulin A (IgA) deficiency, when the patient has antibodies against IgA 9) Patients with a history of deep vein thrombosis or thrombotic complications of IVIG therapy 10) Patients with a body weight of =120 kg 11) Patients with a history of anaphylaxis after previous transfusions of blood or blood products 12) Patients for whom MRI is contraindicated or who are allergic to gadolinium 13)Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method (such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner) while on study 14) Patients with a diagnosis of significant depression 15) Patients with known chronic infectious diseases (e.g. hepatitis B or C, HIV, syphilis, tuberculosis) or malignant disease 16) Patients with known antibody deficiencies or other autoimmune diseases other than MS 17) Patients participating in another study during the course of this study or during the past 3 months or who have ever participated in a study investigating new diseasemodifying or immunosuppressive drugs 18) Patients who are institutionalised or kept in detention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the ability of the HAP score to accurately predict responders to Octagam 5% ;Secondary Objective: • To verify that Octagam 5% in predicted responders is of at least similar effectiveness as the first-line therapies IFN-ß sc or GA • To verify that the HAP score result is of no predictive power for the ARR in IFN-ß sc or GA treated patients • To evaluate the assumption that the HAP score truly predicts the effectiveness of treatment with Octagam 5% and not the progress of disease as such • To investigate the proportion of patients responding to IMP treatment vs. patients not responding • To investigate the effect of IMP treatment on the time to first medically confirmed relapse after 3-month run-in phase • To investigate the effect of IMP treatment on the level of disability, evaluated by means of the EDSS and the MSFC score • To investigate the effect of IMP treatment on the brain by means of MRI parameters (lesion number and volume; whole brain volume) • To investigate the effect of IMP treatment on health-related QoL • To investigate the safety and tolerability of IMP treatment;Primary end point(s): Superiority with regard to decreased ARR of Octagam 5% treatment in patients pre-classified as predicted responders (“RO”) compared to predicted nonresponders (“NRO”) to Octagam 5% treatment;Timepoint(s) of evaluation of this end point: Continuously | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints are: • ARR of Octagam 5% treatment compared to active control (first-line therapy: IFN-ß sc or GA) • ARR of IFN-ß sc or GA treatment compared between predicted responders (“RI/G”) and non-responders (“NRI/G”) to Octagam 5% treatment • Compare ARR of “RO” with both IMP treatment arms combined (“RI/G” and “NRI/G”) • Percentage of actual responders and non-responders in the 21-month period between 3 months after first study treatment administration (“run-in” phase) and the end of treatment period at month 24) • Time from randomisation to first medically confirmed relapse after 3-month run-in phase • Time from last relapse before enrolment to first medically confirmed relapse after 3-month run-in phase • Progression of the disease (defined as an increase of the EDSS), confirmed at 2 separate assessments at least 12 weeks apart • Change in MSFC • Cerebral MRI assessments: number and volumes of Gadolinium-diethylenetriamine penta-acetic acid (Gd-DTPA) enhancing lesions with T1 weighted imaging; number of new and enlarging T2 lesions; number of new T1 Black Holes; volumes of T1 and T2 lesions; whole brain volume • Health-related Quality of Life assessed by MSQOL-54 Secondary safety endpoints are: • Adverse event (AE) monitoring • Vital signs (blood pressure, heart rate, body temperature and respiratory rate) • Standard laboratory safety tests (clinical chemistry and haematology);Timepoint(s) of evaluation of this end point: Continuously | — |
Countries
Austria, Bulgaria, Germany, Hungary, Poland, Russian Federation
Contacts
Public ContactClinical Research Department
Octapharma Pharmazeutika Produktionsgesellschaft m.b. H.
Outcome results
None listed