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

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NCT01145352

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Study Location
Yokohama City University School of
Tokyo, , , Japan
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Contact
1-800-718-1021
[email protected]
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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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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

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Advanced Information
Descriptive Information
Brief Title Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]
Official Title Enbrel-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 Description All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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).
Condition Juvenile Idiopathic Arthritis
Intervention Drug: 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/Cohorts Etanercept (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 Status Completed
Actual Enrollment
 (submitted: November 5, 2013)		113
Original Estimated Enrollment
 (submitted: June 15, 2010)		300
Actual Study Completion Date October 2013
Actual Primary Completion Date October 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
Ages 5 Years to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01145352
Other Study ID Numbers 0881Y1-4689
B1801130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2014