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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 : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Tracking Information
First Submitted Date July 13, 2017
First Posted Date July 14, 2017
Last Update Posted Date August 9, 2019
Actual Study Start Date August 29, 2017
Estimated Primary Completion Date September 15, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2019)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
Original Primary Outcome Measures
 (submitted: July 13, 2017)
  • 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).
Change History Complete list of historical versions of study NCT03218488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 12, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: July 13, 2017)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 12 Years and Older With Moderate to Severe Plaque Psoriasis
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
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Psoriasis
Intervention 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
Study Groups/Cohorts 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).
Intervention: Drug: Ustekinumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 13, 2017)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 25, 2026
Estimated Primary Completion Date September 15, 2026   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries Austria,   Belgium,   Denmark,   France,   Germany,   Netherlands,   Norway,   Russian Federation,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03218488
Other Study ID Numbers CR108277
CNTO1275PSO4056 ( Other Identifier: Janssen-Cilag International NV )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Janssen-Cilag International NV
Study Sponsor Janssen-Cilag International NV
Collaborators Not Provided
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
PRS Account Janssen-Cilag International NV
Verification Date August 2019