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

NCT05155098 | Completed

• 1 other identifier: CAIN457ATH02
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 10

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).

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

Outcome Measures

Primary Outcomes (1)

• Retention rate of secukinumab therapy

  Retention rate is defined as percentage of patients who have not discontinued the medication.

  2 years

Secondary Outcomes (33)

• Retention rate of secukinumab therapy by individual indication

  year 1, year 2

• Change in QoL by EQ-5D Visual Analog Scale (VAS)

  Baseline, month 6, month 12, month 18, month 24

• Treatment pattern

  Month 6, month 12, month 18, month 24

• Work/school absenteeism

  2 years

• Patients with Psoriasis: Proportions of patients achieving a PASI 75, 90, and 100 responses

  Month 6, month 12, month 18, month 24

Study Arms (1)

secukinumab

Patients receiving secukinumab in real world practice

Other: secukinumab

Interventions

secukinumab OTHER

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

secukinumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with moderate to severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Songkhla, Hat Yai, 90110, Thailand

Location

Novartis Investigative Site

Muang, Thailand, 12120, Thailand

Location

Novartis Investigative Site

Khon Kaen, THA, 40002, Thailand

Location

Novartis Investigative Site

Bangkok, 10300, Thailand

Location

Novartis Investigative Site

Bangkok, 10330, Thailand

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

Novartis Investigative Site

Kaen, 40000, Thailand

Location

Novartis Investigative Site

Nakhon Ratchasima, 30000, Thailand

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: March 25, 2022
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (10)