Clinical trial NCT00273858: Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
Official title: Open Label Study To Evaluate The Safety Profile And The Quality Of Life In Patients Receiving Etanercept For The Treatment Of Rheumatoid Arthritis, Ankylosing Spondylitis And Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ankylosing Spondylitis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Keywords: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Month 24
measure: Number of Participants Who Discontinued Treatment
timeFrame: Baseline up to Month 24
measure: Number of Participants by Reasons for Discontinuation of Treatment
timeFrame: Baseline up to Month 24
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month
timeFrame: Baseline, Month 24
measure: Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month
timeFrame: Baseline, Month 24
measure: Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month
timeFrame: Baseline, Month 24
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
state: Asvestohori
city: Athens
country: Greece
facility: Pfizer Investigational Site
state: Maroussi
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Karditsa
country: Greece
facility: Pfizer Investigational Site
city: Larissa
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: