An Observational, multicentre, open label, non interventional programme to assess the long-term safety and efficacy of Somatuline® Autogel® in the treatment of neuroendocrine tumours when administered by patients or their partners (“Home Injection Group”) or administered by Healthcare Professionals (Somatuline NET PMS 215 study)

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

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

Study drug and medical condition

• Medical condition to be studied:
  Neuroendocrine tumour

Population studied

• Short description of the study population:
  Patients (of either sex), who were 18 years of age or above, and who were established on treatment with Somatuline Autogel for NET were enrolled within the 2 year recruitment period, and were remained in the Post Marketing Surveillance (PMS) programme for at least 2 years.; 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.
• 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 patients
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  To assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners (“Home Injection Group”) and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) (“Reference Group”).
• Outcomes:
  Evaluation of incidence of related adverse events and use of concomitant medications in the home injection versus the reference group.
• Data analysis plan:
  As this is an observational Program no formal statistical analysis will be performed, and therefore no sample size calculation has been conducted. All data is summarized descriptively by administration group and by does and injection interval as appropriate.

Documents

Study results

Y-97-52030-215_synopsis-no redactions