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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05155098
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Thailand
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

: secukinumab

Patients receiving secukinumab in real world practice

Interventions

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Bangkoknoi, Bangkok, Thailand

Status

Recruiting

Address

Novartis Investigative Site

Bangkoknoi, Bangkok, 10700

Novartis Investigative Site, Bangkok, Thailand

Status

Recruiting

Address

Novartis Investigative Site

Bangkok, , 10400

Novartis Investigative Site, Chiang Mai, Thailand

Status

Recruiting

Address

Novartis Investigative Site

Chiang Mai, , 50200

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