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Completed

NCT Number: NCT00195338

Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

The purpose of the study is to determine the long term safety of Enbrel in adults with active rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in rheumatology practice patients. All patients initiated with Enbrel will be observed from the start of the study in Feb 2003 for a period of at least 5 years.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Luxembourg, L-2420

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have moderate to severe active rheumatoid arthritis
  • Be aged of 17 years or more
  • Have inadequate response to DMards
  • Give written informed consent
  • Physician decides to prescribe Enbrel

Exclusion criteria

n/a

Treatment and study plan

etanercept

Drug

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to Month 66

    Any untoward medical occurrence in a participant who received study treatment 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.

Secondary outcomes

  1. Percentage of Participants With Completion of Study Treatment

    Time frame: Month 12 through Month 72

  2. Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66

    Time frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66

    Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac.

  3. Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66

    Time frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66

    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 possible score ranged from 0 (no difficulty) to 60 (unable to do).

  4. Mean Dose of Concomitant Methotrexate (MTX) and Steroids

    Time frame: Baseline up to Month 66

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Innovex, Inc

Registry information

Official study title

A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Sep 19, 2005
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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