Clinical trial NCT05155098: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Moderate to Severe Plaque Psoriasis
Psoriatic Arthritis
Ankylosing Spondylitis
Non-radiographic Axial Spondyloarthritis
Keywords: Moderate to severe plaque psoriasis
Psoriatic arthritis
Ankylosing spondylitis
Non-radiographic axial spondyloarthritis
NIS
Thailand
secukinumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention rate of secukinumab therapy
timeFrame: 2 years
Secondary outcomes:
measure: Retention rate of secukinumab therapy by individual indication
timeFrame: year 1, year 2
measure: Change in QoL by EQ-5D Visual Analog Scale (VAS)
timeFrame: Baseline, month 6, month 12, month 18, month 24
measure: Treatment pattern
timeFrame: Month 6, month 12, month 18, month 24
measure: Work/school absenteeism
timeFrame: 2 years
measure: Patients with Psoriasis: Proportions of patients achieving a PASI 75, 90, and 100 responses
timeFrame: Month 6, month 12, month 18, month 24
measure: Patients with Psoriasis: Changes between PASI response categories over time
timeFrame: 2 Years
measure: Patients with Psoriasis: Absolute PASI scores
timeFrame: Month 6, month 12, month 18, month 24
measure: Patients with Psoriasis: Changes in absolute and relative PASI scores over time
timeFrame: Baseline, month 6, month 12, month 18, month 24
measure: Patients with Psoriasis: Proportion of patients achieving a PGA 0/1 response
timeFrame: Month 6, month 12, month 18, month 24
measure: Patients with Psoriasis: Proportion of patients achieving a DLQI 0/1 response
timeFrame: Month 6, month 12, month 18, month 24
measure: Patients with Psoriasis: Correlation between PASI and DLQI score
timeFrame: 2 years
measure: Patients with Psoriatic Arthritis: 78 TJC and 76 SJC
timeFrame: 1 year, 2 years
measure: Patients with Psoriatic Arthritis: Physician's global assessment (PGA)
timeFrame: 1 year, 2 years
measure: Patients with Psoriatic Arthritis: Total patient pain assessed by visual analog scale (VAS)
timeFrame: 1 year, 2 years
measure: Patients with Psoriatic Arthritis: Presence of any dactylitis
timeFrame: 1 year, 2 years
measure: Patients with Psoriatic Arthritis: Presence of any enthesitis
timeFrame: 1 year, 2 years
measure: Patients with Psoriatic Arthritis: Appearance of new bone erosions or worsening of pre-existing erosions
timeFrame: 1 year, 2 years
measure: Patients with Psoriatic Arthritis: Proportion of patients achieving a PASI 75, 90, and 100 response
timeFrame: month 6, month 12, month 18 and month 24
measure: Patients with Psoriatic Arthritis: Changes between PASI response categories over time
timeFrame: 2 years
measure: Patients with Psoriatic Arthritis: Absolute PASI scores
timeFrame: month 6, month 12, month 18 and month 24
measure: Patients with Psoriatic Arthritis: Changes in absolute and relative PASI scores over time
timeFrame: 2 years
measure: Patients with Psoriatic Arthritis: Changes of HAQ-DI score
timeFrame: month 6, month 12, month 18 and month 24
measure: Patients with Psoriatic Arthritis: Changes of FACIT-Fatigue score
timeFrame: month 6, month 12, month 18 and month 24
measure: Patients with Psoriatic Arthritis: Correlation between effectiveness measures, HAQ-DI, and FACIT-Fatigue scores
timeFrame: 2 years
measure: Patients with Ankylosing spondylitis: Bath AS disease activity index (BASDAI) response
timeFrame: year 1, year 2
measure: Patients with Ankylosing spondylitis: Patient's global assessment of disease activity
timeFrame: year 1, year 2
measure: Patients with Ankylosing spondylitis: C-reactive protein (CRP) or high-sensitivity CRP (hsCRP)
timeFrame: year 1, year 2
measure: Patients with Ankylosing spondylitis: Total spinal pain assessed using VAS scale
timeFrame: year 1, year 2
measure: Patients with Ankylosing spondylitis: Presence of any enthesitis
timeFrame: 2 years
measure: Patients with Ankylosing spondylitis: Appearance or worsening of lesions at anterior sites of the vertebrae assessed by X-ray
timeFrame: year 1, year 2
measure: Patients with Ankylosing spondylitis: Appearance or worsening of bone marrow edema (BME) in the spine and/or sacro-iliac joints assessed by magnetic resonance imaging (MRI)
timeFrame: year 1, year 2
measure: Ankylosing spondylitis and non-radiographic axial SpA: Changes of FACIT-Fatigue score compared to baseline
timeFrame: month 6, month 12, month 18 and month 24
measure: Ankylosing spondylitis: Correlation between ASDAS, BASDAI, and FACIT-Fatigue scores
timeFrame: 2 years
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Novartis Investigative Site
state: Hat Yai
city: Muang
country: Thailand
facility: Novartis Investigative Site
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Nakhon Ratchasima
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: