You are here

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

Last updated on July 31, 2018

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 etanercept or other biologic agent

- History of malignancy

NCT01100034
Pfizer
Active, not recruiting
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
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-authorization Safety Study (Pass)

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 (8-17 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 4-17 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.

Non-probability sample
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
dermatology clinics
Psoriasis
Drug: Etanercept
Expected duration of 24 weeks as one course
Other Name: Enbrel
1
pediatric patients with plaque psoriasis on etanercept
Intervention: Drug: Etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
73
October 2018
October 2018   (Final data collection date for primary outcome measure)

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 etanercept or other biologic agent
  • History of malignancy
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Portugal,   Spain
Austria,   Denmark
 
NCT01100034
0881X1-4654
B1801035 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now