Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195338
• Other study ID #: 0881-101343
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 16, 2011
• Start date: May 2004
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• etanercept

Locations

Country	Name	City	State
Luxembourg	Pfizer Investigational Site	Luxembourg

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Innovex, Inc

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Baseline up to Month 66	Yes
Secondary	Percentage of Participants With Completion of Study Treatment		Month 12 through Month 72	No
Secondary	Change From Baseline in Number of Joints With Active Synovitis at 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.	Baseline, Months 6, 12, 18, 30, 42, 54 and 66	No
Secondary	Change From Baseline in Health Assessment Questionnaire (HAQ) Score at 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).	Baseline, Months 6, 12, 18, 30, 42, 54 and 66	No
Secondary	Mean Dose of Concomitant Methotrexate (MTX) and Steroids		Baseline up to Month 66	No

External Links

•   To obtain contact information for a study center near you, click here.