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
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Drug: etanercept

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: May 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: etanercept

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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

  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: NCT00195338

Locations
Luxembourg
Pfizer Investigational Site
Luxembourg, Luxembourg, L-2420
Sponsors and Collaborators
Pfizer
Innovex, Inc
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00195338     History of Changes
Other Study ID Numbers: 0881-101343
Study First Received: September 12, 2005
Results First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014