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Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

Last updated on November 21, 2019

FOR MORE INFORMATION
Study Location
Yokohama City University School of
Tokyo, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Juvenile Idiopathic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
5-16 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients in active polyarticular JIA (restricted to the case of lack of effect by
other treatment) during enrollment period (2.5years).

- Patients receiving Enbrel for JIA as diagnosed by a qualified physician.

- Age 5 - 16 years

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients not administered ENBREL

NCT01145352
Pfizer
Completed
Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

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Juvenile Idiopathic Arthritis
NCT01500551
All Genders
2+
Years
Multiple Sites
Descriptive Information
Brief TitleEnbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]
Official TitleEnbrel-JIA Use Results Survey [All-Case Surveillance]
Brief Summary

This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA.

  1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events
  2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.
Detailed DescriptionAll patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationAll patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).
ConditionJuvenile Idiopathic Arthritis
InterventionDrug: Etanercept (genetical recombination)
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).
Other Name: Enbrel
Study Groups/CohortsEtanercept (genetical recombination)
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).
Intervention: Drug: Etanercept (genetical recombination)
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 StatusCompleted
Actual Enrollment
 (submitted: November 5, 2013)
113
Original Estimated Enrollment
 (submitted: June 15, 2010)
300
Actual Study Completion DateOctober 2013
Actual Primary Completion DateOctober 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients in active polyarticular JIA (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years).
  • Patients receiving Enbrel for JIA as diagnosed by a qualified physician.
  • Age 5 - 16 years

Exclusion Criteria:

  • Patients not administered ENBREL
Sex/Gender
Sexes Eligible for Study:All
Ages5 Years to 16 Years   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01145352
Other Study ID Numbers0881Y1-4689
B1801130
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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