Secukinumab Drug Survival, Effectiveness and Tolerability in Pediatric Patients With Psoriasis

Study Purpose

Multicenter, non-interventional, cohort study in pediatric patients with moderate to severe plaque-type psoriasis. Retrospective data collection is planned at patients' inclusion.

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 6 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Written informed consent and legal representative's permission for study participation obtained prior to beginning of participation in the study. 2. Age ≥6 to <18 years old. 3. Established diagnosis of active moderate-to-severe plaque psoriasis defined as a PASI score ≥ 10, body surface area (BSA) involvement of ≥10% and PGA score ≥ 3 only or with concomitant psoriatic arthritis. 4. Failure or intolerance of prior psoriasis treatment. 5. Patient was prescribed with secukinumab within 4-16 weeks before inclusion. 6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of this non-interventional study conduct.

Exclusion Criteria:

1. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex). 2. History of chronic recurrent infection. 3. Clinically significant infection exacerbation, including active tuberculosis. 4. Age <6 years or ≥18 years. 5. Pregnancy and breastfeeding. 6. Patients participating in parallel in an interventional clinical trial. 7. Patients participating in parallel in other Novartis-sponsored non-interventional study generating primary data for secukinumab. 8. Patients within the safety follow-up phase of interventional study. 9. Active inflammatory bowel disease at inclusion. 10. Patients who received any vaccine within 4 weeks prior to secukinumab initiation. 11. Any medical or psychological condition in the investigator's opinion which may prevent the study participation.

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.

NCT06142357
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 Russian Federation
Conditions

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

Moderate-to-severe Plaque Psoriasis
Additional Details

This observational study will be performed at healthcare facilities treating pediatric psoriasis patients. The study population will consist of a representative group of pediatric patients with moderate-to-severe plaque psoriasis for whom routine treatment with secukinumab according to the approved national label is initiated during 4 to 16 weeks Retrospective data collection is planned at patients' inclusion. Prospective data collection will continue during follow-up routine visits until secukinumab discontinuation or maximum duration of follow-up for 104 weeks after index date.

Arms & Interventions

Arms

: Secukinumab

Pediatric patients with moderate-to-severe plaque psoriasis receiving secukinumab.

Interventions

Other: - Secukinumab

There is no treatment allocation. Patients administered secukinumab by prescription will be enrolled

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, Chelyabinsk, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Chelyabinsk, , 454048

Novartis Investigative Site, Grozny, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Grozny, , 364022

Novartis Investigative Site, Izhevsk, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Izhevsk, , 426009

Novartis Investigative Site, Kazan, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Kazan, , 420012

Novartis Investigative Site, Kemerovo, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Kemerovo, , 650025

Novartis Investigative Site, Moscow, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Moscow, , 119296

Novartis Investigative Site, Moscow, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Moscow, , 119435

Novartis Investigative Site, Moscow, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Moscow, , 119571

Novartis Investigative Site, Mytishchi, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Mytishchi, , 141009

Novartis Investigative Site, Nizhny Novgorod, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Nizhny Novgorod, , 603066

Novartis Investigative Site, Rostov On Don, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Rostov On Don, , 344022

Novartis Investigative Site, Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Saint-Petersburg, , 194100

Novartis Investigative Site, Tula, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Tula, , 300053

Novartis Investigative Site, Yakutsk, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Yakutsk, , 677000

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.