Relapsing Forms of Multiple Sclerosis MedDRA version: 17.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Biogen Idec
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorizations required by local law in accordance with national and local subject privacy regulations. 2. Has participated in the STRATA Study, have stable disease and do not meet reimbursement criteria for natalizumab (Tysabri®) in Belgium, upon termination of the STRATA Study. 3. Are =18 years old. 4. Subjects of child bearing potential must practice effective contraception during the study and be able to continue contraception for 3 months after their last infusion. 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Patients participating in STRATA who were in line with current Belgian reimbursement criteria when they started in one of the feeder studies (Affirm or Sentinel). 2. Subjects with any significant change in clinical status, that in the opinion of the Investigator, would make them unsuitable to participate in this study. The investigator must review the subject’s medical fitness for participation and consider any diseases that would preclude treatment. 3. Subjects that are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator. 4. Female Subjects who are considering becoming pregnant while in the study. 5. Female Subjects of childbearing potential and are not using the appropriate contraception as determined by the Investigator. 6. Female subjects who are currently pregnant or breastfeeding. 7. Any prescheduled elective procedure during the study period that, in the opinion of the Investigator, would interfere with study parameters. 8. Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is long-term safety (incidence and pattern of SAEs) in patients receiving natalizumab.;Secondary Objective: Secondary objectives include long-term efficacy of natalizumab in delaying the progression of disability, reducing the frequency of relapses, MRI activity (for safety reasons) and explore quality of life and cognitive function in patients on treatment with natalizumab for more than 8 years.;Primary end point(s): The primary endpoint of the open label study is the incidence of AEs and SAEs.;Timepoint(s) of evaluation of this end point: When there's an incidence of AEs and SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Disability progression as determined by Expanded Disability Status Scale (EDSS) (based on neurological examination, “physical EDSS”) every six months • MS disease activity as determined by the occurrence of clinical relapses (distribution of the total number of relapses over 2 years) • JCV status (anti-JCV antibody positive or negative according to the STRATIFY JCV® Test, Unilabs, Denmark) • Frequent MRI monitoring according to guidelines Belgian Study Group for MS • Quality of life measurement by EQ-5D every six months • Cognitive evaluation by Symbol Digit Modalities Test (SDMT) every six months ;Timepoint(s) of evaluation of this end point: If patient doesn't want to participate anymore. | — |
Countries
Belgium
Contacts
Public ContactSabrina Wijnen
Clinitude (Division Newx)
Outcome results
None listed