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A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 12 Years and Older With Moderate to Severe Plaque Psoriasis

  Purpose

The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (aged greater than or equal to 12 years to less than 18 years inclusive) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale).

Condition Intervention
Psoriasis Drug: Ustekinumab

Study Type: Observational
Study Design:Observational Model: Cohort
Time Perspective: Prospective
Official Title:An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 12 Years and Older With Moderate to Severe Plaque Psoriasis

Resource links provided by NLM:

Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:

  • Number of Participants With Adverse Events [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]

    An adverse event is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.

    All participants will be monitored for the long-term safety of ustekinumab for the frequency and severity of following adverse events potentially related to immune modulation and of clinical interest such as: serious infections, malignancies, and autoimmunity.

  • Evaluation of Growth: Height [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    Growth will be based on height recorded at baseline and throughout the observational period.

  • Evaluation of Growth: Weight [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    Growth will be based on body weight recorded at baseline and throughout the observational period.

  • Evaluation of Growth: Body Mass Index (BMI) [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    Growth will be based on body weight recorded at baseline and throughout the observational period. BMI is calculated by dividing the body weight (in kilogram) by the square of height (in meters).

  • Sexual Maturity Based on the Tanner scale [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    Tanner scale defined as a scale used to measure visible changes during puberty commonly referred to as “Tanner stages”. Female participants will be evaluated for breast development and pubic hair distribution and male participants are evaluated for development of external genitalia and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics).

Secondary Outcome Measures:

  • Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. Total PASI score ranges from 0 to 72. A PASI 50 response represents participants who achieved at least a 50 percent improvement from baseline in the PASI score.

  • Percentage of Participants Achieving PASI 75 Response [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. Total PASI score ranges from 0 to 72. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.

  • Percentage of Participants Achieving PASI 90 Response [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4. Total PASI score ranges from 0 to 72. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

  • Percentage of Participants Achieving a Physician’s Global Assessment (PGA) Score of 0 or 1 [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    The PGA documents the physician’s assessment of the participant’s psoriasis lesions at a given time point on a 5-point scale, where (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe. Overall lesions are graded for induration, erythema, and scaling. The sum of the 3 scores will be divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.

  • Percentage of Participant’s Body Surface Area (BSA) Covered by Plaque-type Psoriasis [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    Percentage of participant’s body surface area covered by plaque-type psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. The total BSA affected was the summation of individual regions affected.

  • Change From Baseline in Children’s Dermatology Life Quality Index (cDLQI) [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    The Children’s Dermatology Quality Life Index (cDLQI) questionnaire will be used to assess the participant’s perspective on the impact of skin disorders on daily living. It is a 10 item instrument with 4-item response options on a scale from 0 (Not at all) to 3 (Very much) and a recall period of 1 week. The total score ranges from 0 to 30, with lower scores indicating better quality of life.

  • Number of Participants With Comorbidities [ Time Frame: Baseline up to end of data collection (approximately 9 years) ]
    Number of participants will be assessed for the previous and current comorbidities other than pediatric plaque psoriasis.

Estimated Enrollment:75
Actual Study Start Date:August 29, 2017
Estimated Study Completion Date:September 15, 2026
Estimated Primary Completion Date:September 15, 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants With Moderate to Severe Plaque Psoriasis

All Participants diagnosed with moderate to severe plaque psoriasis who will either start therapy with ustekinumab within 30 days of baseline or have started therapy with ustekinumab in the 12-week period before enrollment as per routine clinical practice, will be monitored for the long-term safety of ustekinumab and long-term effects of ustekinumab on growth and development of pediatric participants. The primary data source for the study will be the medical records of participants and standardized questionnaires (completed by the physician and by the participant/parent).
Drug: Ustekinumab

Participants will not receive any intervention as a part of this study. Participants with moderate to severe plaque psoriasis who are initiating treatment with ustekinumab within clinical practice (patients should either start therapy with ustekinumab within 30 days of baseline or have started therapy with ustekinumab in the 12-week period before enrollment for the treatment of psoriasis) will be observed for the long-term safety of ustekinumab and the long-term effects of ustekinumab on growth and development of pediatric participants.
Other Name: STELARA

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