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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Drug interactions
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Drug interaction study, Observational study, Post authorization safety study (PASS)

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SECUKINUMAB
• Additional medical condition(s):
  Plaque type psoriasis (MedDRA 6.0, LLT: 10050576)

Population studied

• Short description of the study population:
  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 2504 patients in approximately 300-400 sites in Germany.; Inclusion Criteria; Patients eligible for inclusion in this study have to fulfill all of the following criteria at baseline (Visit 1, week 0):; 1. Patients must give a written, signed and dated informed consent before documentation in the study will be commenced.; 2. Men or women must be at least 18 years of age.; 3. Diagnosis of clinically moderate to severe plaque-psoriasis. Other forms of psoriasis may be present if moderate to severe plaque-psoriasis is the reason for Secukinumab treatment.; 4. Candidates for systemic therapy.; 5. Documented decision for treatment with marketed Secukinumab in compliance with the prescribing information and the summary of product characteristics.; 6. Initial treatment with marketed Secukinumab planned for the day of the baseline visit.; Exclusion Criteria; Patients fulfilling any of the following criteria at baseline (Visit 1, week 0) are not eligible for inclusion in this study. Conditional exclusion criteria will be activated during the course of the study as soon as predefined recruitment criteria have been met without the need for a protocol amendment. No additional exclusion criteria may be applied by the treating physician, in order to ensure that the study population will be representative of all eligible patients.; 1. Initial treatment with marketed Secukinumab prior to the day of informed consent.; 2. Parallel enrollment in any interventional clinical trial.; 3. Parallel enrollment in a non-interventional study sponsored by Novartis or one of her divisions or affiliates.; 4. After 300 patients who had participated in a clinical trial with Secukinumab prior to inclusion in this NIS have been recruited, no further patien
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  2405

Study design details

• Main study objective:
  The objective of this descriptive study - without any formal a priori hypothesis - 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 as well as effectiveness and safety.
• Outcomes:
  The descriptive primary endpoint of the study is the assessment of the duration of the transition periods from prior treatments to Secukinumab with adequate precision for the following prior treatment categories and groups:• All topical treatments• All conventional systemic treatments (and phototherapy)• All biologic treatments• Fumaric acid esters• Methotrexate• Ciclosporin, • Assessment of transition duration for other prior treatment groups• Proportion of patients in different categories of transition periods related to treatment intervals and systemic terminal half-lives• Relative dose tapering and dose of concomitant treatments• Effectiveness as assessed by PASI and other routine parameters • Safety as assessed in routine treatment (AEs and SAEs
• Data analysis plan:
  The data will be analyzed by Novartis and/or by the designated CRO. All data will be analyzed descriptively. The duration of transition periods will be described by the arithmetic mean, standard deviation, median, inter-quartile range and 95% confidence interval for all relevant treatment categories and groups. Proportions of patients within certain categories of transition periods will be calculated with 95% confidence intervals and displayed by stacked bar plots. Summary statistics will be presented for all other outcome measures.After 800 patients have been recruited, an interim analysis of the baseline data will determine, whether sufficient precision for all groups of previous treatments is likely to be achieved. If necessary, the study sample size will be adjusted via a protocol amendment to obtain adequate and representative coverage of all previous treatment groups.AMEMNDMENT I: Sample size = 2504, an compromise between feasible sample size and an adequate precision

Documents

Study results

CAIN457ADE07 _final CSR_report_V1.0_190131_2_Redacted