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Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Centre Hospitalier Victor Dupouy / Service de Dermatologie
Argenteuil Cedex, , 95107 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 17 years of age or younger

- Diagnosed with plaque psoriasis by a dermatologist.

- Prior to enrollment, there must be a clinical decision to initiate etanercept for the
treatment of plaque psoriasis and etanercept must then be initiated.

- Actively being treated with etanercept, regardless of length of treatment prior to
enrollment

- Willing to provide written informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior therapy with any biologic agent other than etanercept

- History of malignancy

NCT01100034
Pfizer
Completed
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis

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Descriptive Information
Brief TitleStudy Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
Official TitleA LONG-TERM, PROSPECTIVE, OBSERVATIONAL COHORT STUDY OF THE SAFETY AND EFFECTIVENESS OF ETANERCEPT IN THE TREATMENT OF PAEDIATRIC PSORIASIS PATIENTS IN A NATURALISTIC SETTING: A POST-AUTHORISATION SAFETY STUDY (PASS)
Brief Summary

Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of the world's population. The epidemiology of pediatric psoriasis has not been well documented and no treatment guidelines exist for pediatric psoriasis.

Etanercept is a biologic drug and has been licensed for the treatment of chronic severe plaque psoriasis in children and adolescents (6-17 years of age) who are inadequately controlled by or are intolerant to, other systemic therapies or phototherapies. Although the long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis (JIA) has been studied and the short-term safety profile of etanercept in both JIA and pediatric psoriasis appears similar, there is limited data available about the long-term effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim of this study is to assess the safety and effectiveness of etanercept for the treatment of pediatric psoriasis in Europe. Patients aged <=17 with plaque psoriasis diagnosed by a dermatologist will be invited to participate in the registry only after a clinical decision has been made to prescribe etanercept. The safety of the drug and how well the drug works will be evaluated during the follow-up period. The follow-up period will last 5 years and patients will be followed up every 3 months for the first 2 years and every 6 months for the next 3 years or until the end of study.

Detailed DescriptionNon-probability sample
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationdermatology clinics
ConditionPsoriasis
InterventionDrug: Etanercept
Expected duration of 24 weeks as one course
Other Name: Enbrel
Study Groups/Cohorts1
pediatric patients with plaque psoriasis on etanercept
Intervention: Drug: Etanercept
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 StatusCompleted
Actual Enrollment
 (submitted: March 5, 2018)
72
Original Estimated Enrollment
 (submitted: April 7, 2010)
200
Actual Study Completion DateSeptember 24, 2018
Actual Primary Completion DateSeptember 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 17 years of age or younger
  • Diagnosed with plaque psoriasis by a dermatologist.
  • Prior to enrollment, there must be a clinical decision to initiate etanercept for the treatment of plaque psoriasis and etanercept must then be initiated.
  • Actively being treated with etanercept, regardless of length of treatment prior to enrollment
  • Willing to provide written informed consent

Exclusion Criteria:

  • Prior therapy with any biologic agent other than etanercept
  • History of malignancy
Sex/Gender
Sexes Eligible for Study:All
Ages6 Years to 17 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesFrance,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Portugal,   Spain
Removed Location CountriesAustria,   Denmark
 
Administrative Information
NCT NumberNCT01100034
Other Study ID Numbers0881X1-4654
B1801035 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

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