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

NCT01100034 | Completed Results

• 2 other identifiers: 0881X1-4654B1801035
• Study Type: observational
• Target: 72
• Locations: 8 countries
• Sites: 29

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.

Conditions

Psoriasis

Keywords

pediatric psoriasis; etanercept; PASS; safety; effectiveness

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants

  Serious infections were defined as any infections those were life-threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalisation. Opportunistic infections of interest included protocol-specified infections due to bacteria: Salmonella bacteremia, Campylobacteriosis, Shigellosis, Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium kansasii, Syphilis, Pseudomonas aeruginosa, Acinetobacter baumannii, Listeriosis, Nocardiosis, Legionellosis, Actinomycosis, Bartonellosis; Fungal: Aspergillosis, Invasive Candida albicans, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Blastomycosis, Paracoccidioidomycosis, Sporotrichosis, Penicilliosis, Zygomycosis and Pneumocystosis; Protozoans: Cryptosporidiosis, Isosporiasis, Microsporidiosis, Acanthamoebiasis, Toxoplasmosis, Trypanosomiasis and Leishmaniasis; Viral: Cytomegalovirus, John Cunningham Virus, Disseminated or central nervous system herpes zoster, Kaposi's sarcoma and BK virus.

  Baseline up to 5 years

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

  Baseline up to 28 days after last dose of study drug (up to 61 months)

• Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants

  Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.

  Baseline up to 24 weeks

• Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants

  Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.

  Week 24 up to Week 216

• Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants

  Participants those who completed the initial treatment period of at least 24 weeks and entered the follow up period, and during the follow up period who required subsequent treatment with etanercept or other systemic therapies were reported.

  Week 24 up to Week 216

Secondary Outcomes (1)

• Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period

  Week 24 up to Week 216

Study Arms (1)

1

pediatric patients with plaque psoriasis on etanercept

Drug: Etanercept

Interventions

Etanercept DRUG

Expected duration of 24 weeks as one course

Also known as: Enbrel

1

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

dermatology clinics

You may qualify if:

• 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

You may not qualify if:

• Prior therapy with any biologic agent other than etanercept
• History of malignancy

Sponsors & Collaborators

• Pfizer: lead

Study Sites (29)

Centre Hospitalier Victor Dupouy / Service de Dermatologie

Argenteuil, 95107, France

Location

CHRU Tours Hopital Trousseau

Chambray-lès-Tours, 37170, France

Location

CHU de Nantes - Hôtel Dieu

Nantes, 44093, France

Location

CH Quimper Cornouaille

Quimper, 29000, France

Location

Charite Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Universitaetsklinik Koeln

Cologne, 50937, Germany

Location

Universitaetsklinik Carl Gustav Carus

Dresden, 01307, Germany

Location

Hautklinik Universitaetsklinikum Erlangen

Erlangen, 91052, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

J W Goethe Universitaet Frankfurt

Frankfurt am Main, 60590, Germany

Location

Kath. Kinderkrankenhaus Wilhelmstift

Hamburg, 53757, Germany

Location

Kinderklinik der Johannes-Gutenberg Universitat Mainz

Mainz, 55101, Germany

Location

Asklepios Klinik Sankt Augustin GmbH

Sankt Augustin, 53757, Germany

Location

Andreas Syngros Hospital

Athens, 16121, Greece

Location

University of Athens, Andreas Syngros Hospital

Athens, 16121, Greece

Location

Skin and Venereal Diseases' Hospital

Thessaloniki, 54643, Greece

Location

Heim Pal Children's Hospital

Budapest, 1089, Hungary

Location

Universita degli Studi di Napoli Federico II

Napoli, 80131, Italy

Location

Universita degli Studi di Napoli

Napoli, 80131, Italy

Location

University of Padova

Padua, 35128, Italy

Location

ARNAS Civico Di Gristina M Ascoli

Palermo, 90127, Italy

Location

Università Cattolica del Sacro Cuore Policlinico A.

Roma, 00168, Italy

Location

Ospitale Alfredo Fiorini

Terracina, 04019, Italy

Location

UMC St Radbound

Nijmegen, 6500 HB, Netherlands

Location

Erasmus MC

Rotterdam, 3000 CA, Netherlands

Location

Hospital Santa Maria

Lisbon, 1649-028, Portugal

Location

Hospital de la Santa Cruz y San Pablo

Barcelona, 08025, Spain

Location

Hospital Parc Tauli

Barcelona, 08208, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: November 19, 2010
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); GR (3); IT (6); NL (2); FR (4); PT (1); HU (1); DE (9)