Status:
COMPLETED
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Lead Sponsor:
Pfizer
Conditions:
Juvenile Idiopahtic Arthritis
Eligibility:
All Genders
2-30 years
Phase:
PHASE3
Brief Summary
This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) \[extended oligoarticular JIA, enthestitis related arthriti...
Eligibility Criteria
Inclusion
- Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)
- Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.
Exclusion
- Exclusion criteria for subject planning to continue investigational product:
- withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).
- History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.
Key Trial Info
Start Date :
October 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2021
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01421069
Start Date
October 10 2011
End Date
February 4 2021
Last Update
November 14 2022
Active Locations (35)
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1
The Children's Hospital at Westmead
Westmead, Sydney, New South Wales, Australia, 2145
2
Royal Children's Hospital
Parkville, Melbourne, Victoria, Australia, 3052
3
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
4
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000