STELARA: A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

Sponsor

Janssen-Cilag International NV (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03218488

Collaborator

(none)

105

Enrollment

Locations

180.1

Anticipated Duration (Months)

3.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (6 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	Phase
Psoriasis	Drug: Ustekinumab

Study Design

Study Type:

Observational

Anticipated Enrollment :

105 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

Actual Study Start Date :

Aug 29, 2017

Anticipated Primary Completion Date :

Aug 31, 2032

Anticipated Study Completion Date :

Aug 31, 2032

Arms and Interventions

Arm	Intervention/Treatment
Participants 6-18 years of Age 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 in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in 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. 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 part of this study. Participants with moderate to severe plaque psoriasis who are initiating treatment with ustekinumab in clinical practice (patients should either start therapy with ustekinumab within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in 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. Other Names: STELARA

Arm

Intervention/Treatment

Participants 6-18 years of Age 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 in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in 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. 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 part of this study. Participants with moderate to severe plaque psoriasis who are initiating treatment with ustekinumab in clinical practice (patients should either start therapy with ustekinumab within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in 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.

Other Names:

STELARA

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events [Baseline up to end of data collection (approximately 8 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 adverse events potentially related to immune modulation and of clinical interest such as: serious infections, malignancies, and autoimmunity.
Evaluation of Growth: Height [Baseline up to end of data collection (approximately 8 years)]
Growth will be based on height recorded at baseline and throughout the observational period.
Evaluation of Growth: Weight [Baseline up to end of data collection (approximately 8 years)]
Growth will be based on body weight recorded at baseline and throughout the observational period.
Evaluation of Growth: Body Mass Index (BMI) [Baseline up to end of data collection (approximately 8 years)]
Growth will be based on body weight recorded at baseline and throughout the observational period. Sex and age adjusted BMI will be calculated by dividing the body weight (in kilograms) by the square of height (in meters).
Sexual Maturity Based on the Tanner scale [Baseline up to end of data collection (approximately 8 years)]
The Tanner scale is used to measure visible changes during puberty commonly referred to as "Tanner stages". Female participants are 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 [Baseline up to end of data collection (approximately 8 years)]
The PASI is a measure for assessing and grading the severity and extent of psoriatic lesions and their response to therapy. The PASI measure also accounts for body surface area of psoriasis involvement. In the PASI measure, 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 at least 50 percent improvement from baseline in the PASI score.
Percentage of Participants Achieving PASI 75 Response [Baseline up to end of data collection (approximately 8 years)]
The PASI is a measure for assessing and grading the severity and extent of psoriatic lesions and their response to therapy. The PASI measure also accounts for body surface area of psoriasis involvement. In the PASI measure, 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 at least 75 percent improvement from baseline in the PASI score.
Percentage of Participants Achieving PASI 90 Response [Baseline up to end of data collection (approximately 8 years)]
The PASI is a measure for assessing and grading the severity and extent of psoriatic lesions and their response to therapy. The PASI measure also accounts for body surface area of psoriasis involvement. In the PASI measure, 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 at least 90 percent improvement from baseline in the PASI score.
Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of 0 or 1 [Baseline up to end of data collection (approximately 8 years)]
The PGA documents the physician's assessment of the severity of the participant's psoriasis lesions at a given time 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 [Baseline up to end of data collection (approximately 8 years)]
Percentage of participant's body surface area covered by plaque-type psoriasis was estimated using the palm method: the area equivalent to the participant's palm extending to the proximal interphalangeal joints and thumb = 1 percent (%) of BSA. The total BSA affected was the summation of the BSA of the individual regions affected.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) [Baseline up to end of data collection (approximately 8 years)]
The Children's Dermatology Quality Life Index (CDLQI) questionnaire is 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 [Baseline up to end of data collection (approximately 8 years)]
Participants are assessed for pre-existing and new comorbidities associated with pediatric plaque psoriasis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in 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 in 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
Participants (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 participants (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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Uniklinik Graz	Graz	Austria	8036
2	UCL Hopital Saint-Luc	Bruxelles	Belgium	1200
3	UZ Leuven	Leuven	Belgium	3000
4	CHU de Liège - Domaine Universitaire du Sart Tilman	Liege	Belgium	4000
5	Grand Hôpital de Charleroi	Loverval	Belgium	6280
6	Bispebjerg Hospital	Copenhagen	Denmark	NV 2400
7	Gentofte Herlev Hospital	Hellerup	Denmark	2800
8	Odense Universitetshospital	Odense C	Denmark	5000
9	CH Victor Dupouy Argenteuil	Argenteuil	France	95107
10	CHRU Besançon -Hôpital Jean Minjoz	Besançon Cedex	France	25030
11	Groupe Hospitalier Pellegrin CHU de Bordeaux	Bordeaux	France	33076
12	ICH Hopital A. Morvan	Brest Cedex 2	France	29609
13	Le Bateau Blanc	Martigues	France	13500
14	Hôpital Necker Enfants Malades	Paris Cedex 15	France	75743
15	CHU Saint-Etienne - Hôpital Nord	Saint-Etienne Cedex 2	France	42055
16	Klinikum der Johann Wolfgang Goethe -Universitaet	Frankfurt	Germany	60590
17	Universitatsklinikum Schleswig-Holstein - Kiel	Kiel	Germany	24105
18	Praxis Dr. med. Beate Schwarz - Germany	Langenau	Germany	89129
19	Gemeinschaftspraxis Dres. Quist	Mainz	Germany	55128
20	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz	Germany	55131
21	Andreas Sygros Hospital	Athens	Greece	16121
22	University Hospital for Skin and Venereal Diseases	Thessaloniki	Greece	54 643
23	Radboudumc	Nijmegen	Netherlands	6525 EX
24	Oslo universitetssykehus HF, Rikshospitalet	Oslo	Norway	0027
25	Moscow Research-Practical Center of Dermatovenerology and Cosmetology	Moscow	Russian Federation	119049
26	FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences	Moscow	Russian Federation	119991
27	Llc Ultramed	Omsk	Russian Federation	644024
28	Saint-Petersburg State Pediatric Medical Academy of RosZdrav	Sankt-Peterburg	Russian Federation	194353
29	Centre hospitalier universitaire vaudois	Lausanne	Switzerland	1011
30	Kinderspital Zürich	Zürich	Switzerland	8032
31	University Hospital of Wales	Cardiff	United Kingdom	CF14 4XW
32	Whipps Cross University Hospital	London	United Kingdom	E11 1NR
33	Great Ormond Street Hospital	London	United Kingdom	WC1N 3JH
34	Salford Royal Hospital	Salford	United Kingdom	M6 8HD

Sponsors and Collaborators

Janssen-Cilag International NV

Investigators

Study Director: Janssen-Cilag International NV Clinical Trial, Janssen-Cilag International NV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen-Cilag International NV

ClinicalTrials.gov Identifier:

NCT03218488

Other Study ID Numbers:

CR108277
CNTO1275PSO4056

First Posted:

Jul 14, 2017

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Psoriasis

Ustekinumab

Study Results

No Results Posted as of Aug 18, 2022