Incidence rates of Cutaneous T-Cell Lymphomas (CTCL) among patients with atopic dermatitis (AD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50517
• EU PAS number:
  EUPAS50516
• Study ID:
  50517
• Official title and acronym:
  Incidence rates of Cutaneous T-Cell Lymphomas (CTCL) among patients with atopic dermatitis (AD)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study description:
  This is a cohort study describing population incidence rates of cutaneous T-cell lymphomas (CTCL), patient-level incidence rates of CTCL following diagnosis of atopic dermatitis (AD), and patient-level incidence rates of CTCL following treatment for severe AD. The study population was the general population in the UK and patients visiting general practices in Germany.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 31/10/2022

Actual: 31/10/2022

Study start date

Planned: 31/10/2022

Actual: 31/10/2022

Date of final study report

Planned: 16/12/2022

Actual: 19/12/2022

Sources of funding

EMA

Study protocol

Initial protocol

Analysis-Plan-AD and CTCL-Nov 2022-for publication

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable