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

This study has been terminated.
(The study was terminated because at least one year follow-up was achieved for each patient and the achievement of 965 exposure years to the drug.)
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00273858
First received: January 4, 2006
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Ankylosing Spondylitis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Other: There is no Intervention. The study is observational.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 24 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to Month 24 ] [ Designated as safety issue: Yes ]
  • Number of Participants by Reasons for Discontinuation of Treatment [ Time Frame: Baseline up to Month 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    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 Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.

  • Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.


Enrollment: 880
Study Start Date: March 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273858

Locations
Greece
Pfizer Investigational Site
Thessaloniki, Asvestohori, Greece, 570 10
Pfizer Investigational Site
Athens, Maroussi, Greece, 145 61
Pfizer Investigational Site
Athens, Greece, 16673
Pfizer Investigational Site
Athens, Greece, 115 27
Pfizer Investigational Site
Athens, Greece, 184 54
Pfizer Investigational Site
Athens, Greece, 115 26
Pfizer Investigational Site
Karditsa, Greece, 43100
Pfizer Investigational Site
Larissa, Greece, 411 10
Pfizer Investigational Site
Thessaloniki, Greece, 546 42
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00273858     History of Changes
Other Study ID Numbers: 0881A-101695, B1801106
Study First Received: January 4, 2006
Results First Received: June 30, 2011
Last Updated: September 8, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 29, 2014