Pediatric PsoriasisNCT01432249
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
An observational study of Pediatric Psoriasis, run by Pfizer.
Trial summary
Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Pediatric Psoriasis
- What is being tested?
- Enbrel group
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients (ages of 8~17)
Who may be able to join
- Children and adolescents aged 8 years to 17 years at time of consent
- Chronic severe psoriasis patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies
Who cannot join
- Patients with known hypersensitivity to Enbrel or any component of the product
- Patients with active infections including chronic or localized infections such as tuberculosis (Treatment of Enbrel should not be initiated)
About this study
Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600 subjects administered in the setting of routine practice during the initial 4 years after new indication approved.
Read the detailed description
All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.
- Conditions
- Pediatric Psoriasis
- Being tested
- Enbrel group
- Keywords
- pediatric psoriasis, enbrel, safety, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enbrel groupDrug
will be decided by treating physicians
| Study group | Role | What they receive |
|---|---|---|
| Enbrel | The patients who are prescribed Enbrel for pediatric psoriasis Receives: Drug: Enbrel group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by discontinuation due to adverse events
Measured: 6 month
Secondary outcomes (2)
Proportion of subjects achieving a status on the PGA (Physician's Global Assessment) of psoriasis of clear (0), clear/almost clear (0/1), or clear/almost clear/mild (0/1/2) at 12 weeks and 24 weeks
Measured: 6 month
Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startMar 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- 0 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
- NCT01432249
- Sponsor's protocol ID
- B1801135
- Status last verified
- Nov 2013
- First submitted
- 5 Aug 2011
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT01432249
- Acronym / sponsor ID
- B1801135
- Conditions
- Pediatric Psoriasis
- Keywords
- pediatric psoriasis, enbrel, safety, efficacy
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600 subjects administered in the setting of routine practice during the initial 4 years after new indication approved.
Detailed description
All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enbrel | – | Drug: Enbrel groupThe patients who are prescribed Enbrel for pediatric psoriasis |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients (ages of 8~17)
Key inclusion criteria (2 listed)
- Children and adolescents aged 8 years to 17 years at time of consent
- Chronic severe psoriasis patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies
Key exclusion criteria (2 listed)
- Patients with known hypersensitivity to Enbrel or any component of the product
- Patients with active infections including chronic or localized infections such as tuberculosis (Treatment of Enbrel should not be initiated)
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 |
|---|---|---|
| Enbrel groupwill be decided by treating physicians | Drug | Enbrel |
Primary outcome
Safety measured by discontinuation due to adverse events
Time frame: 6 month
2 secondary outcomes
Proportion of subjects achieving a status on the PGA (Physician's Global Assessment) of psoriasis of clear (0), clear/almost clear (0/1), or clear/almost clear/mild (0/1/2) at 12 weeks and 24 weeks
Time frame: 6 month
Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks
Time frame: 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Pediatric Psoriasis
RecruitingPhase 3
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
Crohns Disease, Colitis, Ulcerative
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
Active, not recruitingPhase 3
A Long-term Extension Study of Ustekinumab in Pediatric Participants
Crohn Disease, Colitis, Ulcerative
Active, not recruitingObservational study
A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
Psoriasis
RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Psoriasis, run by Pfizer.
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 2 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: withdrawn, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety measured by discontinuation due to adverse events (time frame: 6 month). 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 18 Nov 2013.