Assessing the Safety of Ixekizumab in European Psoriasis Registries (I1F-EW-B008)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45112
• EU PAS number:
  EUPAS21980
• Study ID:
  45112
• Official title and acronym:
  Assessing the Safety of Ixekizumab in European Psoriasis Registries (I1F-EW-B008)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study status:
  Ongoing

Research institution and networks

Institutions

University Medical Centre Hamburg-Eppendorf

Germany

British Association of Dermatologists Biologics Register Limited (BADBIR)

German Rheumatism Research Centre Berlin (Deutsches Rheuma-Forschungszentrum Berlin, DRFZ)

Germany

BRITISH ASSOCIATION OF DERMATOLOGISTS BIOLOGICS REGISTER LIMITED  (BADBIR) UK, University Medical Center Hamburg-Eppendorf (UKE) Germany, Deutsches Rheuma-Forschungszentrum (DRFZ) Germany

Study timelines

Date when funding contract was signed

Actual: 19/10/2016

Study start date

Actual: 25/05/2017

Date of final study report

Planned: 31/12/2029

Sources of funding

Other

More details on funding

BADBIR, PsoBest, RABBIT

Study protocol

Initial protocol

B008 PASS (0.1)_Redacted

Updated protocol

B008 PASS (a)_Redacted

Regulatory

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