JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri: STRATIFY-2

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, longitudinal

Study drug and medical condition

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

Population studied

• Short description of the study population:
  The study involved the US patients with relapsing multiple sclerosis receiving commercial Tysabri. Patients may participate in other clinical studies sponsored by Biogen Idec or Elan, however, if the anti-JCV antibody test is included in another study, they should withdraw from STRATIFY-2.; The incidence of progressive multifocal leukoencephalopathy in Tysabri-treated patients was also analysed.; Inclusion criteria:; - All patients who are enrolled and have provided at least one serum sample will be included in the analysis
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 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:
  Patients with progressive multifocal leukoencephalopathy
• Estimated number of subjects:
  35895

Study design details

• Main study objective:
  The primary objective of this study is to demonstrate that the incidence of progressive multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in participants who have detectable antibodies to JCV (antibody positive).
• Outcomes:
  •Demonstrate that the incidence of PML in natalizumab-treated participants who do not have detectable antibodies to JC virus (JCV) (antibody negative) is lower than in patents who have detectable antibodies to JCV (antibody positive), •Estimate the incidence of PML in natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody positive •Define the prevalence of anti-JCV antibody in relapsing MS participants receiving natalizumab within the TOUCH Prescribing Program •Determine changes in anti-JCV antibody status over time
• Data analysis plan:
  All appropriate background data will be summarized by presenting frequency distribution and/or basic summary statistics. The incidence of PML in patients testing anti-JCV antibody positive and in those testing, negative will be presented separately and compared using a 1-sided Fisher’s Exact Test. The percentage of patients who have tested anti-JCV antibody positive will be presented for those receiving Tysabri in the TOUCH Prescribing Program and for those who are interested in or are considering beginning Tysabri treatment. In addition, the percentage of patients who have anti-JCV antibody status changes from negative to positive over time will be presented. The data from this study will be analyzed separately and in combination with the data from the STRATIFY-1 study (Biogen Idec study 101JC401).

Documents

Study results

101JC402 CSR Synopsis V1 Section 2 Final 01Dec2016__Redacted