Incidence rates of morphoea, systemic sclerosis and scleroderma

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50511
• EU PAS number:
  EUPAS50510
• Study ID:
  50511
• Official title and acronym:
  Incidence rates of morphoea, systemic sclerosis and scleroderma
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Romania
• Study description:
  This was a cohort study describing population- and patient-level incidence rates of morphoea (including localised and linear scleroderma), systemic sclerosis and scleroderma (including both systemic and localised/linear in a number of European databases. The study population was patients visiting general practices in Germany, France, Italy and Romania
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 26/09/2022

Actual: 26/09/2022

Study start date

Planned: 26/09/2022

Actual: 26/09/2022

Date of final study report

Planned: 16/12/2022

Actual: 20/12/2022

Sources of funding

EMA

Study protocol

Initial protocol

Final analysis plan - morphoea - 20221021

Regulatory

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