Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    35
  • sponsor
    Novartis Pharmaceuticals
Updated on 28 June 2022
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (8.0 mi away) Contact
+21 other location
psoriasis
arthritis
psoriasis vulgaris

Summary

This is a multicenter, centrally registered observational study without a control group. This observational study is a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.

Description

For patients who discontinued or completed this drug before the end of the observation period, the investigator will record adverse events that occurred within 30 days after the day following the last administration of this drug, or the day of discontinuation of the survey (the day when discontinuation of the survey was judged), whichever is later, in the CRF.

If a patient withdraws consent, information will be collected during the observation period up to the date of consent withdrawal.

Details
Condition Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis
Treatment Cosentyx
Clinical Study IdentifierNCT05215561
SponsorNovartis Pharmaceuticals
Last Modified on28 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who have obtained written consent from their legally acceptable representative to cooperate in this survey before the start of treatment with this drug
Patients aged less than 18 years at the start of treatment with this drug
Patients newly treated with this drug for any of the following diseases: Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis

Exclusion Criteria

Prior treatment with this drug
Participation in an interventional study (e.g., a clinical trial) at the time of starting this drug
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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