Know Cancer

or
forgot password

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


Phase 2/Phase 3
2 Years
30 Years
Open (Enrolling)
Both
Juvenile Idiopahtic Arthritis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of malignancy

Outcome Time Frame:

up to 8 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

European Union: European Medicines Agency

Study ID:

B1801023

NCT ID:

NCT01421069

Start Date:

October 2011

Completion Date:

January 2021

Related Keywords:

  • Juvenile Idiopahtic Arthritis
  • Use of etanercept to treat pediatric subjects with extended oligoarticular JIA
  • enthestitis related arthritis (ERA)
  • or psoriatic arthritis (PsA).
  • Arthritis
  • Arthritis, Psoriatic
  • Arthritis, Juvenile Rheumatoid

Name

Location