Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

This study has been completed.
Sponsor:
Collaborator:
Innovex, Inc
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00195338
First received: September 12, 2005
Last updated: December 16, 2011
Last verified: December 2011

September 12, 2005
December 16, 2011
May 2004
December 2010   (final data collection date for primary outcome measure)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 66 ] [ Designated as safety issue: Yes ]
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.
Not Provided
Complete list of historical versions of study NCT00195338 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Completion of Study Treatment [ Time Frame: Month 12 through Month 72 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ 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 possible score ranged from 0 (no difficulty) to 60 (unable to do).
  • Mean Dose of Concomitant Methotrexate (MTX) and Steroids [ Time Frame: Baseline up to Month 66 ] [ Designated as safety issue: No ]
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Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients will be included after the physician decided to prescribe Enbrel.

Rheumatoid Arthritis
Drug: etanercept
1
This is an open label, observational study.This is a post-marketing surveillance study in rheumatology practice patients in Luxemburg.Rheumatologists will be asked to document safety and adherence to therapy of Enbrel when given to adults with active rheumatoid arthritis.All patients initiated with Enbrel will be observed.
Intervention: Drug: etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2010
December 2010   (final data collection date for primary outcome measure)

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

Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Luxembourg
 
NCT00195338
0881-101343
Yes
Pfizer
Pfizer
Innovex, Inc
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP