An observational, multicentre, open label, non-interventional programme to assess the long-term safety and efficacy of Somatuline® Autogel® in the treatment ofneuroendocrine tumours when administered by patients or their partners (“Home Injection Group”) or administered by Healthcare Professionals

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

  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post-marketing surveillance programme

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LANREOTIDE ACETATE
• Anatomical Therapeutic Chemical (ATC) code:
  (H01CB03) lanreotide

  lanreotide
• Medical condition to be studied:
  Neuroendocrine tumour

Population studied

• Short description of the study population:
  All patients must fulfil the following:; 1) The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this PMS programme and any subsequent data analysis.; 2) The patient must have been receiving treatment with Somatuline Autogel at a stable dose and frequency for at least 4 months.; 3) The patient must have a diagnosis of NET.; 4) The patient must be at least 18 years of age.; For patients receiving or intending to start to receive Somatuline Autogel by home injection:; 5) The patient must be able to store the Somatuline Autogel safely in a refrigerator in their own home and either collect it from their GP / Pharmacy on a regular basis, or receive the medication by a home delivery service.; Exclusion Criteria; Patients will not be included in the programme if:; • The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
• Age groups:
  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:
  Neuroendocrine tumour (NET) patients
• Estimated number of subjects:
  25

Study design details

• Main study objective:
  To assess the safety and local tolerability of the long-term use of Somatuline Autogel
• Outcomes:
  The following data will be evaluated in order to assess the long-term safety: incidence of adverse events (AEs) and serious adverse events (SAEs) considered to be related to Somatuline Autogel in both groups, concomitant medications / therapies / surgical procedures, the incidence of local injection site tolerability. The long-term efficacy of Somatuline Autogel when administered by home-injection will be compared to the efficacy following administration by a HCP 24 hrs 5-HIAA urine levels, Tumour size, NET symptoms.
• Data analysis plan:
  As this is an observational programme no formal statistical analysis will be performed, and therefore no sample size calculation has been conducted. All data will be summarised descriptively by administration group and/or by dose and injection interval as appropriate

Documents

Study results

a9b52030220-synopsis