Clinical trial NCT05215561: Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP
Official title: A Special Drug Use-results Survey to Evaluate the Safety and Efficacy of Subcutaneous Administration of Cosentyx in Pediatric Patients With Psoriasis Vulgaris, Psoriatic Arthritis, or Pustular Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Psoriatic Arthritis
Pustular Psoriasis
Keywords: psoriasis vulgaris
psoriatic arthritis
pustular psoriasis
NIS
Japan
Cosentyx
pediatric
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 36
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients who received Cosentyx

Brief summary: This was a multicenter, centrally registered observational study without a control group. This observational study was 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.

Detailed description: For patients who discontinued or completed this drug before the end of the observation period, the investigator recorded 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 withdraw consent, information was collected during the observation period up to the date of consent withdrawal.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of serious adverse events
timeFrame: 52 weeks
Secondary outcomes:
measure: Subjects with psoriasis vulgaris and psoriatic arthritis: IGA mod 2011 with 0 or 1 response
timeFrame: Baseline, week 4, week 12, week 24 and week 52
measure: Subjects with psoriasis vulgaris and psoriatic arthritis: PASI 75/90/100 response
timeFrame: Baseline, week 4, week 12, week 24 and week 52
measure: All patients: Change from baseline in CDLQI
timeFrame: Baseline, week 4, week 12, week 24 and week 52
measure: Subjects with psoriatic arthritis: Change from baseline in C-HAQ
timeFrame: Baseline, week 4, week 12, week 24 and week 52
measure: Subjects with psoriatic arthritis: Change from baseline in JADAS -27
timeFrame: Baseline, week 4, week 12, week 24 and week 52
measure: Subjects with pustular psoriasis: Change from Baseline in the Japanese Dermatological Association (JDA) Severity Index
timeFrame: Baseline, week 4, week 12, week 24 and week 52
measure: Subjects with pustular psoriasis: General improvement in GPP
timeFrame: Baseline, week 4, week 12, week 24 and week 52
measure: Incidence of adverse events and adverse drug reactions
timeFrame: 52 weeks
measure: Incidence of adverse events and adverse reactions included in the safety specifications
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Obihiro
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Mito
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kahoku-gun
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Kamigyo-ku
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Ikoma
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Moriguchi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka Sayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sakai-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Sumida-Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Akita
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: