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
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 for subject planning to continue investigational product:
withdrawal from investigational product in study 0881A1-3338 for any reason (safety or
History of maliginancy other than squamous cell, basal cell carcinoma or cervical
carcinoma in situ.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurrence of malignancy
Outcome Time Frame:
up to 8 years
Pfizer CT.gov Call Center
European Union: European Medicines Agency
- Juvenile Idiopahtic Arthritis
- Use of etanercept to treat pediatric subjects with extended oligoarticular JIA
- enthestitis related arthritis (ERA)
- or psoriatic arthritis (PsA).
- Arthritis, Psoriatic
- Arthritis, Juvenile Rheumatoid