2 Years Prospective Study to Collect Real-life Data on the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis

2 Years Prospective Study to Collect Real-life Data On the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial spondyloarthriTis (PROMPT)

ClinicalTrials.gov Identifier: NCT05155098

Novartis Reference Number: CAIN457ATH02

Last Update: Mar 24, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This is an observational, prospective primary data collection study. The duration of observation is 2 years after study enrolment date. Disease and treatment history will be retrospectively reviewed from medical record at enrollment with no time limits for the key diagnosis of enrolment (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthropathy).

Condition

Moderate to Severe Plaque Psoriasis

Psoriatic Arthritis

Ankylosing Spondylitis

Non-radiographic Axial Spondyloarthritis

Phase

Not Given

Overall status

Recruiting

Start date

Mar 25, 2022

Completion date

Feb 28, 2025

Gender

All

Age(s)

18 Years - 80 Years (Adult, Older Adult)

Interventions

Other

secukinumab

Prospective observational study. There is no treatment allocation. Patients who are receiving or intend to receive secukinumab are eligible to enroll into this study.

Eligibility Criteria

Inclusion Criteria:

Written informed consent of the patient to participate in the study
Age 18-80 years.
Patients with an assured diagnosis by the treating physician of active moderate to severe plaque psoriasis or active PsA or active AS or active non-radiographic axial SpA.
Patients must have received the official approval to receive secukinumab in Dermatology Disease Prior Authorization (DDPA) or Rheumatology Disease Prior Authorization (RDPA) before study participation or the decision to treat patient's condition with secukinumab is happened before entering the study
Patients must receive the first dose of secukinumab during the study enrollment period.
Patients for whom the decision for a therapy with secukinumab is made by the attending treating physician, regardless of this non-interventional study.
Patients who have EQ-5D score before start the 1st dose secukinumab.

Exclusion Criteria:

Any medical or psychological condition in the treating physician's opinion which may prevent the patient from study participation for the 2 year study period.*
Patients participating in parallel in other interventional clinical trial.

Patients participated in an interventional clinical trial with secukinumab involvement in the past.

Note: For example, patients diagnosed with a terminal illness and those with cognitive impairment due to dementia and Alzheimer's disease.