PsoriasisPURPOSENCT01100034
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
An observational study of Psoriasis, run by Pfizer at 29 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Etanercept
- How many people
- 72 participants
- Where
- 29 sitesin 8 countries
- Study dates
- 19 Nov 2010to 24 Sep 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: dermatology clinics
Who may be able to join
- 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
Who cannot join
- Prior therapy with any biologic agent other than etanercept
- History of malignancy
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
Germany9 sites
Charite Universitaetsmedizin Berlin
Berlin, 10117
Universitaetsklinik Koeln
Cologne, 50937
Universitaetsklinik Carl Gustav Carus
Dresden, 01307
Hautklinik Universitaetsklinikum Erlangen
Erlangen, 91052
Universitätsklinikum Essen
Essen, 45122
J W Goethe Universitaet Frankfurt
Frankfurt am Main, 60590
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, 53757
Kinderklinik der Johannes-Gutenberg Universitat Mainz
Mainz, 55101
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, 53757
Italy6 sites
Universita degli Studi di Napoli Federico II
Naples, 80131
Universita degli Studi di Napoli
Naples, 80131
University of Padova
Padova, 35128
ARNAS Civico Di Gristina M Ascoli
Palermo, 90127
Università Cattolica del Sacro Cuore Policlinico A.
Roma, 00168
Ospitale Alfredo Fiorini
Terracina, 04019
France4 sites
Centre Hospitalier Victor Dupouy / Service de Dermatologie
Argenteuil, 95107
CHRU Tours Hopital Trousseau
Chambray-lès-Tours, 37170
CHU de Nantes - Hôtel Dieu
Nantes, 44093
CH Quimper Cornouaille
Quimper, 29000
Greece3 sites
Andreas Syngros Hospital
Athens, 16121
University of Athens, Andreas Syngros Hospital
Athens, 16121
Skin and Venereal Diseases' Hospital
Thessaloniki, 54643
Spain3 sites
Hospital de la Santa Cruz y San Pablo
Barcelona, 08025
Hospital Parc Tauli
Barcelona, 08208
Hospital Universitario La Paz
Madrid, 28046
Netherlands2 sites
UMC St Radbound
Nijmegen, 6500 HB
Erasmus MC
Rotterdam, 3000 CA
About this study
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)
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.
Read the detailed description
Non-probability sample
- Conditions
- Psoriasis
- Being tested
- Etanercept
- Keywords
- pediatric psoriasis, etanercept, PASS, safety, effectiveness
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
Expected duration of 24 weeks as one course
| Study group | Role | What they receive |
|---|---|---|
| 1 | pediatric patients with plaque psoriasis on etanercept Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24 up to Week 216
Secondary outcomes (1)
Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period
Measured: Week 24 up to Week 216
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study start19 Nov 2010
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100034
- Sponsor's protocol ID
- 0881X1-4654
- Other IDs
- B1801035
- Acronym
- PURPOSE
- Status last verified
- Oct 2019
- First submitted
- 6 Apr 2010
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01100034
- Acronym / sponsor ID
- PURPOSE / 0881X1-4654
- Conditions
- Psoriasis
- Keywords
- pediatric psoriasis, etanercept, PASS, safety, effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2010 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 8 Apr 2010 (estimated)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Etanerceptpediatric patients with plaque psoriasis on etanercept |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- dermatology clinics
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Prior therapy with any biologic agent other than etanercept
- History of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: EnbrelExpected duration of 24 weeks as one course | Drug | 1 |
Primary outcome
Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants
Time frame: Baseline up to 5 years
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.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants
Time frame: Baseline up to 28 days after last dose of study drug (up to 61 months)
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.
Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants
Time frame: Baseline up to 24 weeks
Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.
Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants
Time frame: Week 24 up to Week 216
Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.
Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants
Time frame: Week 24 up to Week 216
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.
1 secondary outcome
Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period
Time frame: Week 24 up to Week 216
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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/data_requests.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Pfizer at 29 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, Italy, France, Greece, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants (time frame: Baseline up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.