Real life effect of an epoietin alpha biosimilar Retacrit® on response to chemotherapy-induced anemia and fatigue at 16 weeks in elderly patients (ELDER)

Study identification

• EU PAS number:
  EUPAS23428
• Study ID:
  23429
• Official title and acronym:
  Real life effect of an epoietin alpha biosimilar Retacrit® on response to chemotherapy-induced anemia and fatigue at 16 weeks in elderly patients (ELDER)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Non-interventional longitudinal, prospective, multicenter, cohort study conducted among a representative sample of public and/or private hospital-based oncologists and hematologists practicing in France. Data will be collected by the physician during three visits, from the patient’s medical record, questioning and clinical examination performed during these visits :Baseline visit – V1 initiation of Retacrit®.Follow-up visit – V2: 8 weeks after inclusion.Follow-up visit – V3: maximum 16 weeks after inclusion or 4 weeks after the last recorded dose of ESA or current chemotherapy regimen. Data regarding the patient’s fatigue will be collected directly by the patients using the FACIT-Fatigue scale filled in at each visit.The primary objective of this study is to assess, in real-life settings, the effect of an ESA biosimilar (Retacrit®) on chemotherapy induced anemia response rate(a) and fatigue (FACIT-Fatigue)(b) at 16 weeks in elderly patients (aged 70 years and over) and to confirm the possible relationship between these two criteria.The secondary objectives:Determine the impact of an ESA biosimilar (Retacrit®) on performance status at 16 weeks.Assess the modalities of use of an ESA biosimilar (Retacrit®) and its safety on this specific population.Physician selection: 200 oncologists and/or hematologist.Patient selection: physicians will be allowed to include 10 patients, with the potential to enroll more subjects upon sponsor approval, until a cohort of around 1.800 patients has been obtained.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Networks

NIHR Medicines for Children Research Network

Study timelines

Date when funding contract was signed

Planned:12/06/2015

Study start date

Planned:01/10/2015

Date of final study report

Planned:01/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

PFIZER

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable