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Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

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NCT01421069

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
The Children's Hospital at Westmead
Westmead, Sydney, New South Wales, 2145 Australia
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Juvenile Idiopahtic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-30 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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.

NCT01421069
Pfizer
Active, not recruiting
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
An Open-label Extension Study To Assess The Long-term Safety And Clinical Benefit Of Etanercept In Children And Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-related Arthritis, Or Psoriatic Arthritis Who Were Previously Enrolled In Protocol 0881a1-3338-ww(b1801014)
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 arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).
Not Provided
Interventional
Phase 3
Masking: None (Open Label)
Primary Purpose: Treatment
Juvenile Idiopahtic Arthritis
Drug: etanercept

Subjects aged <18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW).

Subjects aged greater than or equal to 18 years or >62 kg will receive etanercept SC at a dose of 50 mg QW.
Experimental: 1
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.
 
Active, not recruiting
109
March 2021
March 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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 Criteria:

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.
Sexes Eligible for Study: All
2 Years to 30 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Colombia,   Czechia,   France,   Germany,   Hungary,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain
Czech Republic
 
NCT01421069
B1801023
0881A1-3342 ( Other Identifier: Alias Study Number )
2010-023802-10 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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