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)

Novartis

Status: Completed

Conditions: Moderate to Severe Plaque Psoriasis; Psoriatic Arthritis; Non-radiographic Axial Spondyloarthritis; Ankylosing Spondylitis

Treatments: Other: secukinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05155098

CAIN457ATH02

Details and patient eligibility

About

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).

Full description

After the baseline visit, data will be collected for each patient prospectively every 6 months for up to 2 years. At each visit, effectiveness parameters, as well as the patients' QoL and treatment pattern will be documented.

Enrollment: 127 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent of the patient to participate in the study
2. Age 18-80 years.
3. 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.
4. 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
5. Patients must receive the first dose of secukinumab during the study enrollment period.
6. Patients for whom the decision for a therapy with secukinumab is made by the attending treating physician, regardless of this non-interventional study.
7. Patients who have EQ-5D score before start the 1st dose secukinumab.

Exclusion criteria

1. 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.*

2. Patients participating in parallel in other interventional clinical trial.

3. 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.

Trial design

127 participants in 1 patient group

secukinumab

Description:

Patients receiving secukinumab in real world practice

Treatment:

Other: secukinumab