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)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    360
  • sponsor
    Novartis Pharmaceuticals
Updated on 23 July 2022
psoriasis
secukinumab
arthritis
spondyloarthropathy
axial spondyloarthritis
spondyloarthropathies
spondylitis
ankylosing spondylitis
plaque psoriasis

Summary

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).

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.

Details
Condition Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis
Treatment Secukinumab
Clinical Study IdentifierNCT05155098
SponsorNovartis Pharmaceuticals
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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