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

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

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.

Study Overview

• Status: Terminated
• Conditions: Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Ankylosing Spondylitis
• Intervention / Treatment: Other: There is no Intervention. The study is observational.

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.

• Study Type: Observational
• Enrollment (Actual): 880

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 115 27
    • Pfizer Investigational Site
  • Athens, Greece, 115 26
    • Pfizer Investigational Site
  • Athens, Greece, 16673
    • Pfizer Investigational Site
  • Athens, Greece, 184 54
    • Pfizer Investigational Site
  • Karditsa, Greece, 43100
    • Pfizer Investigational Site
  • Larissa, Greece, 411 10
    • Pfizer Investigational Site
  • Thessaloniki, Greece, 546 42
    • Pfizer Investigational Site
  • Asvestohori
    • Thessaloniki, Asvestohori, Greece, 570 10
      • Pfizer Investigational Site
  • Maroussi
    • Athens, Maroussi, Greece, 145 61
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
etanercept; 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).	Other: There is no Intervention. The study is observational.; The study is observational and the prescription follows the SmPC of etanercept.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to Month 24
Number of Participants Who Discontinued Treatment		Baseline up to Month 24
Number of Participants by Reasons for Discontinuation of Treatment		Baseline up to Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Month 24
Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month	PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.	Baseline, Month 24

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 4, 2006
• First Submitted That Met QC Criteria: January 4, 2006
• First Posted (Estimate): January 9, 2006

Study Record Updates

• Last Update Posted (Estimate): September 12, 2011
• Last Update Submitted That Met QC Criteria: September 8, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Bone Diseases, Infectious; Ankylosis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: 0881A-101695; B1801106