Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
This study has been completed.
Information provided by (Responsible Party):
First received: September 12, 2005
Last updated: December 16, 2011
Last verified: December 2011
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||17 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients will be included after the physician decided to prescribe Enbrel.
- 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
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
|Pfizer Investigational Site
|Luxembourg, Luxembourg, L-2420 |
||Pfizer CT.gov Call Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
|Results First Received:
||December 16, 2011
||December 16, 2011
||European Union: European Medicines Agency
Keywords provided by Pfizer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2014
Connective Tissue Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents