PROSPECT: Observational, descriptive study of PRior and concomitant psoriasis treatments in patients receiving Secukinumab in the routine treatment of moderate to severe plaque-type psoriasiss

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38173
• EU PAS number:
  EUPAS10715
• Study ID:
  38173
• Official title and acronym:
  PROSPECT: Observational, descriptive study of PRior and concomitant psoriasis treatments in patients receiving Secukinumab in the routine treatment of moderate to severe plaque-type psoriasiss
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  It is expected that in routine treatment of psoriasis, due to the current recommendations and medical practice, transition periods before administration of Secukinumab will be short. Also, some concomitant treatments with pharmacologically active substances will be given in parallel, tapered or stopped only after the effectiveness of Secukinumab in the individual patient becomes evident, despite lack of experience in their combined application. The objective of this descriptive study is to assess prior and concomitant psoriasis treatments in patients receiving Secukinumab in the routine treatment of moderate to severe plaque-type psoriasis, focusing on duration of transition periods from prior treatments to Secukinumab and on the use of concomitant treatments. Furthermore, effectiveness as assessed in clinical routine as well as safety will be described. This is a single-cohort, non-interventional study with a study duration of 24 weeks recruiting patients for whom the decision of treatment with Secukinumab for plaque-psoriasis has been made before inclusion. It is expected that most patients are likely to be seen at the regular visits at weeks 0, 4, 12, 16, and 24 and that some patients may also be seen at some of the additional visits at weeks 1, 2, 3, 8, and 20. The study population will consist of a representative group of adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy and for whom routine treatment with Secukinumab is planned. The goal is to recruit a total of approximately 1200 patients in approximately 300-400 sites in Germany.
• Study status:
  Finalised

Research institution and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 300 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/06/2015

Actual: 16/07/2015

Study start date

Planned: 01/09/2015

Actual: 27/08/2015

Data analysis start date

Planned: 30/06/2016

Date of interim report, if expected

Planned: 31/12/2016

Date of final study report

Planned: 30/09/2018

Actual: 31/01/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceuticals AG

Study protocol

Initial protocol

PROSPECT-NIS Protocol Final Redacted 2015-06-18

Updated protocol

CAIN457ADE07_PROSPECT-NIS_Protocol_Am1_2016-05-13_clean_redacted

Regulatory

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

Other study registration identification numbers and links

CAIN457ADE07