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

NCT ID: NCT05155098

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-25

Study Completion Date

2025-08-20

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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secukinumab

Patients receiving secukinumab in real world practice

secukinumab

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Songkhla, Hat Yai, Thailand

Site Status

Novartis Investigative Site

Muang, Thailand, Thailand

Site Status

Novartis Investigative Site

Khon Kaen, THA, Thailand

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Chiang Mai, , Thailand

Site Status

Novartis Investigative Site

Kaen, , Thailand

Site Status

Novartis Investigative Site

Nakhon Ratchasima, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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CAIN457ATH02

Identifier Type: -

Identifier Source: org_study_id

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