Relapse Remitting Multiple Sclerosis MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Mabthera or biosimilar rituximab product
Product Name: Rituximab
Product Code: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Numbe
Sponsors
Medical University of Vienna - Department of Neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent obtained before any trial related activities • Ability to understand the nature and the purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the trial • In female subjects either childbearing potential terminated by surgery or one year post- menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant • Diagnosis of RR-MS and existing or planned rituximab treatment 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Patients with HepBc antibodies • Clinically relevant infection (1 drinks/day, defined according to USDA Dietary Guidelines) • Pregnancy (positive pregnancy test at screening or during study phase), lactation or unreliable contraception in female subjects with child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to investigate whether 100mg rituximab every 10-12 weeks are equally effective compared to other, currently used dosing regimens. This will be evaluated by the annualized relapse rate at 48 weeks;Secondary Objective: To investigate the number of new gadolinium enhancing MRI lesions within 48 weeks. To investigate the number of new T2-weighted MRI lesions within 48 weeks. To investigate the changes in the Expanded Disability Status Scale (EDSS). To investigate the CD19/CD20+ cell counts in the course of the trial. To investigate the immunogenicity of both treatments by measuring neutralizing anti-drug antibodies (NADA) and human anti-chimeric antibodies (HACA). To calculate the reduction in drug costs. To assess the safety and adverse events of very low doses of rituximab. ;Primary end point(s): The primary endpoint, the annualized relapse rate, will be calculated during the final visit.;Timepoint(s) of evaluation of this end point: 48 weeks after first infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Annualized relapse rate at other time points (each infusion day) - CD19/20+ cell counts - MRI lesions (both gadolinium enhancing and T2-weighted) - Number of relapses (total and relative) - Immunogenicity (HACA and NADA) - EDSS ;Timepoint(s) of evaluation of this end point: EDSS, CD19/20+ cell counts, no of relapses, relapse rate annualized: at all visits MRI and Immunogenicity: screening and final visit | — |
Countries
Austria
Contacts
Public ContactOffice of the Dept. of Neurology
Medical University of Vienna - Department of Neurology
Outcome results
None listed