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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

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ClinicalTrials.gov Identifier: NCT03218488
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Brief Summary:
The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (12 years to 17 years of age at the time of inclusion) 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 or disease Intervention/treatment
Psoriasis Drug: Ustekinumab

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Study Type : Observational
Estimated Enrollment : 75 participants
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
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : September 15, 2026
Estimated Study Completion Date : November 25, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

Group/Cohort Intervention/treatment
Participants With Moderate to Severe Plaque Psoriasis
All Participants diagnosed with moderate to severe plaque psoriasis who will either start therapy with ustekinumab within 2 months after the first assessment within the study or have started therapy with ustekinumab in the 12-week period before the first assessment within the study 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 2 months after the first assessment within the study or have started therapy with ustekinumab in the 12-week period before the first assessment within the study 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




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Baseline up to end of data collection (approximately 6 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.


  2. Evaluation of Growth: Height [ Time Frame: Baseline up to end of data collection (approximately 6 years) ]
    Growth will be based on height recorded at baseline and throughout the observational period.

  3. Evaluation of Growth: Weight [ Time Frame: Baseline up to end of data collection (approximately 6 years) ]
    Growth will be based on body weight recorded at baseline and throughout the observational period.

  4. Evaluation of Growth: Body Mass Index (BMI) [ Time Frame: Baseline up to end of data collection (approximately 6 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).

  5. Sexual Maturity Based on the Tanner scale [ Time Frame: Baseline up to end of data collection (approximately 6 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 :
  1. Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response [ Time Frame: Baseline up to end of data collection (approximately 6 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.

  2. Percentage of Participants Achieving PASI 75 Response [ Time Frame: Baseline up to end of data collection (approximately 6 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.

  3. Percentage of Participants Achieving PASI 90 Response [ Time Frame: Baseline up to end of data collection (approximately 6 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.

  4. 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 6 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.

  5. Percentage of Participant's Body Surface Area (BSA) Covered by Plaque-type Psoriasis [ Time Frame: Baseline up to end of data collection (approximately 6 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.

  6. Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) [ Time Frame: Baseline up to end of data collection (approximately 6 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.

  7. Number of Participants With Comorbidities [ Time Frame: Baseline up to end of data collection (approximately 6 years) ]
    Number of participants will be assessed for the previous and current comorbidities other than pediatric plaque psoriasis.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of pediatric participants (12 years to 17 years of age at the time of inclusion) with a diagnosis of moderate to severe plaque psoriasis who are initiating treatment with ustekinumab within clinical practice.
Criteria

Inclusion Criteria:

  • Have a confirmed diagnosis of moderate to severe chronic plaque psoriasis
  • Either start therapy with ustekinumab for the treatment of psoriasis within 2 months after the first assessment within the study or have started therapy with ustekinumab in the 12-week period before the first assessment within the study; a. the treatment decision must have been taken independently of and prior to a participant's inclusion in the study; b. where participants have started therapy with ustekinumab before the first assessment within the study, appropriate baseline data at the start of ustekinumab treatment must be documented, including psoriasis area and severity index (PASI), physician global assessment of disease (PGA), body surface area (BSA) and children's dermatology life quality index (cDLQI) scores where available
  • Participant (and/or a legally-acceptable representative/guardian where applicable) must sign a participation agreement/informed consent form (ICF) allowing source data collection and verification in accordance with local requirements and the participant (and/or a legally-acceptable representative/guardian where applicable) must be able to understand and complete the requested patient-reported outcomes (PROs)
  • Be willing to participate in the study

Exclusion Criteria:

  • Is enrolled in an interventional clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218488


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV

Additional Information:
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Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT03218488     History of Changes
Other Study ID Numbers: CR108277
CNTO1275PSO4056 ( Other Identifier: Janssen-Cilag International NV )
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents