Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

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NCT01421069

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Study Location
The Children's Hospital at Westmead
Westmead, Sydney, New South Wales, 2145, Australia
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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:

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1-800-718-1021

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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.

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Juvenile Idiopahtic ArthritisExtension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
NCT01421069
  1. Westmead, Sydney, New South Wales
  2. Parkville, Melbourne, Victoria
  3. Brussels,
  4. Gent,
  5. Bucaramanga, Santander
  6. Brno,
  7. Praha 2,
  8. Praha 2,
  9. Paris,
  10. Paris,
  11. Berlin,
  12. Bremen,
  13. Hamburg,
  14. Saint Augustin,
  15. Budapest,
  16. Chieti Scalo,
  17. Riga,
  18. Riga,
  19. Vilnius,
  20. Mexico, D.f.
  21. Utrecht,
  22. Oslo,
  23. Bydgoszcz,
  24. Krakow,
  25. Warszawa,
  26. Wroclaw,
  27. Moscow,
  28. Saint-Petersburg,
  29. Belgrade,
  30. Nis,
  31. Piestany,
  32. Ljubljana,
  33. Esplugues de Llobregat, Barcelona
  34. Madrid,
  35. Valencia,
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Official Title  ICMJE 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)
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 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Juvenile Idiopahtic Arthritis
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: 1
Intervention: Drug: etanercept
Publications * Foeldvari I, Constantin T, Vojinovi? J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Su?i? G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dole?alová P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2014)		109
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2011)		100
Actual Study Completion Date  ICMJE February 4, 2021
Actual Primary Completion Date February 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Colombia,   Czechia,   France,   Germany,   Hungary,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01421069
Other Study ID Numbers  ICMJE B1801023
0881A1-3342 ( Other Identifier: Alias Study Number )
2010-023802-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP