A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, non-interventional, multicenter, open label long-term safety study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  NATALIZUMAB
• Medical condition to be studied:
  Relapsing-remitting multiple sclerosis

Population studied

• Short description of the study population:
  Patients with relapsing-remitting Multiple sclerosis (MS) who participated in STRATA, had stable disease for at least 7 years during STRATA, and did not meet reimbursement criteria for Tysabri® in Belgium, upon termination of the STRATA study.; Inclusion Criteria:; 1. Had the ability to understand the purpose and risks of the study and provided signed and dated informed consent and any authorizations required by local law in accordance with national and local subject privacy regulations.; 2. Had participated in the STRATA study, had stable disease and did not meet reimbursement criteria for natalizumab (Tysabri®) in Belgium, upon termination of the STRATA study.; 3. Were ≥18 years old.; 4. Patients of child bearing potential had to practice effective contraception during the study and be able to continue contraception for 3 months after their last infusion.; 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. Patients with any significant change in clinical status that, in the opinion of the Investigator, would have made them unsuitable to participate in this study. The Investigator had to review the patient’s medical fitness for participation and consider any diseases that would have precluded treatment.; 3. Patients that were unwilling or unable to comply with study requirements, or were deemed unsuitable for study participation as determined by the Investigator. 4. Female patients who were considering becoming pregnant while in the study.; 5. Female patients of childbearing potential who were not using the appropriate contraception as determined by the Investigator.; 6. Female patients who were currently pregnant or breastfeeding.; 7. Any prescheduled elective procedure during the study period that, in the opinion of the Investigator, would have interfered with study parameters.; 8. Any other condition, clinical finding, or reason that, in
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Multiple sclerosis patients
• Estimated number of subjects:
  10

Study design details

• Main study objective:
  The primary objective for this study is long-term safety (incidence and pattern of SAEs) in patients receiving natalizumab. The primary objective is to evaluate the safety of natalizumab in patients with Relapsing Forms of Multiple Sclerosis who were included in STRATA and did not meet reimbursement criteria upon termination of STRATA.
• Outcomes:
  • The primary endpoint of the open label study is the incidence of AEs and SAEs. • Disability progression • MS disease activity • JCV status • Frequent MRI monitoring • Quality of life measurement by EQ-5D • Cognitive evaluation by Symbol Digit Modalities Test (SDMT)
• Data analysis plan:
  The purpose of this study is to evaluate the safety and efficacy of natalizumab in patients with Relapsing Forms of Multiple Sclerosis who were included in STRATA and did not meet reimbursement criteria upon termination of STRATA. The study will also evaluate the long-term effectiveness of natalizumab in delaying the progression of disability, reducing the frequency of relapses, and MRI activity during long-term treatment with natalizumab. Quality of Life measurements and cognitive evaluations will be measured on a 6-monthly basis.