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

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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