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

Wyeth is now a wholly owned subsidiary of Pfizer880 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

880

Conditions

Ankylosing Spondylitis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis, Ankylosing

Interventions

There is no Intervention. The study is observational.OTHER

The study is observational and the prescription follows the SmPC of etanercept.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Pfizer Investigational Site

Thessaloniki, Asvestohori, Greece

Pfizer Investigational Site

Athens, Maroussi, Greece

Pfizer Investigational Site

Athens, Greece

Pfizer Investigational Site

Athens, Greece

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: Baseline up to Month 24

Number of Participants Who Discontinued Treatment

Time frame: Baseline up to Month 24

Number of Participants by Reasons for Discontinuation of Treatment

Time frame: Baseline up to Month 24

Secondary Outcomes

Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month

HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation.

Time frame: Baseline, Month 24

Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month

PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.

Time frame: Baseline, Month 24

Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month

Data from ClinicalTrials.gov

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