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Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

NCT01421069

CompletedPhase 3

Sponsor: Pfizer

Conditions: Juvenile Idiopahtic Arthritis

Interventions: etanercept

Countries: Australia, Belgium, Colombia, Czechia, France, Germany, Hungary, Italy

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).

Eligibility overview

Sex: ALL

Age: 2 Years to 30 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (35)
  • Westmead, Sydney, New South Wales, Australia
  • Parkville, Melbourne, Victoria, Australia
  • Brussels, Belgium
  • Ghent, Belgium
  • Bucaramanga, Santander Department, Colombia
  • Brno, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Paris, France
  • Paris, France
  • Berlin, Germany
  • Bremen, Germany
  • Hamburg, Germany
  • Saint Augustin, Germany
  • Budapest, Hungary
  • Chieti Scalo, Italy
  • Riga, Latvia
  • Riga, Latvia
  • Vilnius, Lithuania
  • México, D.F., Mexico
  • Utrecht, Netherlands
  • Oslo, Norway
  • Bydgoszcz, Poland
  • Krakow, Poland
  • Warsaw, Poland
  • Wroclaw, Poland
  • Moscow, Russia
  • Saint Petersburg, Russia
  • Belgrade, Serbia
  • Niš, Serbia
  • + 5 more on CT.gov