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Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Westmead, Sydney, New South Wales, 2145 Australia
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
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male and female subjects with a diagnosis per International League of Associations for
Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis
(JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between
the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and
17 years.

- >= 2 active joints and the following for the relevant JIA subtype: extended
oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response
to a disease modifying antirheumatic drug (DMARD); or ERA with a history of
intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug
(NSAID) or a DMARD.

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

- Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated
arthritis per ILAR criteria.

- Other rheumatic diseases.

- Active uveitis within 6 months of the baseline visit.

- Any other significant health problem.

NCT00962741
Pfizer
Completed
Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

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Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
A 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arthritis, Juvenile Idiopathic
Drug: Etanercept
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Other Name: Enbrel
Experimental: 1
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Intervention: Drug: Etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
January 2013
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects with a diagnosis per International League of Associations for Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis (JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and 17 years.
  • >= 2 active joints and the following for the relevant JIA subtype: extended oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response to a disease modifying antirheumatic drug (DMARD); or ERA with a history of intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug (NSAID) or a DMARD.

Exclusion Criteria:

  • Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria.
  • Other rheumatic diseases.
  • Active uveitis within 6 months of the baseline visit.
  • Any other significant health problem.
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Colombia,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain
Argentina,   Brazil,   Denmark,   Greece,   Sweden,   Taiwan
 
NCT00962741
0881A1-3338
B1801014
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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