Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

Wyeth

Status: Terminated

Conditions: Spondylitis, Ankylosing; Arthritis, Psoriatic; Ankylosing Spondylitis; Arthritis, Rheumatoid

Treatments: Other: There is no Intervention. The study is observational.

Study type: Observational

Funder types: Industry

Identifiers

NCT00273858

B1801106

0881A-101695

Details and patient eligibility

About

This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.

Full description

Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).

Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.

Enrollment: 880 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older at time of consent
• Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis or has a diagnosis of ankylosing spondylitis or psoriatic arthritis, as determined by the doctor
• Provides informed consent
• Demonstrate a negative serum or urine pregnancy test prior to administration of etanercept. Sexually active women participating in the study must use a medically acceptable form of contraception.
• Patients already prescribed etanercept according to approved labelling

Exclusion criteria

• Has hypersensitivity to etanercept
• Has sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with active infections (ie. hepatitis C, hepatitis B, active TBC)
• Is pregnant or breast-feeding
• Has significant concurrent medical diseases including, uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, or central nervous system (CNS) demyelinating events suggestive of multiple sclerosis
• Has a history of confirmed blood dyscrasias
• Received any live (attenuated) vaccines within 4 weeks of screening visit

Trial design

880 participants in 1 patient group

etanercept

Description:

Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).

Treatment:

Other: There is no Intervention. The study is observational.