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

NCT01100034

Last updated date
Study Location
Centre Hospitalier Victor Dupouy / Service de Dermatologie
Argenteuil Cedex, , 95107, France
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
Official Title A 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 Description Non-probability sample
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 dermatology clinics
Condition Psoriasis
Intervention Drug: Etanercept
Expected duration of 24 weeks as one course
Other Name: Enbrel
Study Groups/Cohorts 1
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 Status Completed
Actual Enrollment
 (submitted: March 5, 2018)
72
Original Estimated Enrollment
 (submitted: April 7, 2010)
200
Actual Study Completion Date September 24, 2018
Actual Primary Completion Date September 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
Ages 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Portugal,   Spain
Removed Location Countries Austria,   Denmark
 
Administrative Information
NCT Number NCT01100034
Other Study ID Numbers 0881X1-4654
B1801035 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not 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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2019