Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate MedDRA version: 12.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Sponsors
Västerbottens läns landsting
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study if all of the following criteria apply: • Between the age of 18 and 55 years (inclusive) of age • Diagnosis of Relapsing Remitting MS according to the revised McDonald criteria OR one demyelinating episode in conjunction with at least two high intensity T2 lesions with size and location compatible with MS • Treatment with any of the first line injectible DMD:s, ie Avonex, Betaferon, Rebif or Copaxone • In fertile females, willing to comply with effective contraceptive methods. These include birthcontrol pills, surgical sterilization of patient or partner or consistent use of condom by partner. Nonfertile women is defined as more than 5 years since menopaus or, in case of ambiguities, an FSH level above 30 IU/L 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria applies: • Diagnosis of Secondary Progressive MS • Bleeding diathesis or medication contraindicating lumbar puncture • Pregnant or lactating women • Patients having contraindication for or otherwise not compliant with MRI investigations • Documented vulnerability to infections • Simultaneous treatment with other immunosuppressive drugs • Documented allergy or intolerance to Rituximab • Severe psychiatric condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasability and safety of switching from injectible MS treatments to Mabthera in stable relapsing-remitting multiple sclerosis (RRMS) To study the effects on inflammatory parameters on magnetic resonance imaging when switching MS therapy to Mabthera in RRMS To study the development of neurodegenerative processes after therapy switch to Rituximab using quantitative MRI measurements and analysis of biomarkers for axonal damage in the cerebrospinal fluid (CSF) ;Secondary Objective: To make health economic assessments and compare cost – effectiveness between the present first line disease-modifying drugs (DMDs) with Rituximab To compare patient satisfaction and health related quality of life between the present first line DMD:s and Rituximab ;Primary end point(s): The primary endpoints are • To document the safety and feasibility of Rituximab treatment in a non-selected population of RRMS patients using a new target based treatment protocol. • The number of Gd-enhancing active lesions in two MRI scans performed three months apart in a run–in period before therapy switch compared with two MRI scans three months apart with the first scan performed three months after therapy switch. The MRI scans will be performed with double dose contrast and 15 minutes delay to maximize the sensitivity. • The amount of retreatment needed within a two year period after one treatment cycle of Rituximab based on our treatment protocol • The yearly relapse rate calculated from the two-year period before therapy switch compared with the yearly relapse rate first and second year after therapy switch • The change in brain parenchymal fraction (BPF), total brain volume, total volume grey matter, total lesion volume and total myelin content between investigations before therapy switch and one and two years after therapy switch. Since there is no comparable period before therapy switch measuring these values, these analyses may only document if there appears to b | — |
Countries
Sweden
Outcome results
None listed