Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
- Conditions
- Arthritis, RheumatoidSpondylitis, AnkylosingAnkylosing SpondylitisArthritis, Psoriatic
- Interventions
- Other: There is no Intervention. The study is observational.
- Registration Number
- NCT00273858
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 880
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description etanercept There is no Intervention. The study is observational. 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).
- Primary Outcome Measures
Name Time Method Number of Participants by Reasons for Discontinuation of Treatment Baseline up to Month 24 Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to Month 24 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.
Number of Participants Who Discontinued Treatment Baseline up to Month 24
- Secondary Outcome Measures
Name Time Method Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month Baseline, Month 24 PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.
Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month Baseline, Month 24 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.
Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month Baseline, Month 24 PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇷Thessaloniki, Greece