Study Evaluating Enbrel in Adults With Active Rheumatoid Arthritis in Luxemburg - Full Text View

Sponsors and Collaborators:	Wyeth Innovex, Inc
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195338

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	Phase
Rheumatoid Arthritis	Drug: etanercept	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Post-Marketing Surveillance Looking at Safety and Adherence to Treatment of Enbrel in Adults With Active Rheumatoid Arthritis in Luxemburg

Further study details as provided by Wyeth:

Primary Outcome Measures:

To determine the long term safety of Enbrel in adults with active rheumatoid arthritis. [ Time Frame: Follow-up visits will take place at 6, 12 and 18 months following treatment initiation, and yearly thereafter (at 30, 42, 54, and 66 months). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the percentage of adult patients with RA that stay on a treatment with Enbrel [ Time Frame: 6 months - 66 months ] [ Designated as safety issue: No ]
To determine the effect of Enbrel on number of joints with active synovitis and quality of life as measured by HAQ when treatment is provided in daily practice. [ Time Frame: 6 - 66 months ] [ Designated as safety issue: No ]
To determine the possible reduction/elimination of concomitant medications (MTX/steroids) in RA and JRA [ Time Frame: 6-66 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	February 2003
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (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 Enbrel will be prescribed according to the specifications of the scientific leaflet. A 50 mg dose should be given as one subcutaneous (SC) injection using either a 50 mg single-use prefilled syringe or a single-use prefilled SureClick™ autoinjector.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195338

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Luxembourg
	Recruiting
Esch-sur-Alzette, Luxembourg, L-4243
	Not yet recruiting
Esch-sur-Alzette, Luxembourg, L-4170
	Recruiting
Luxembourg, Luxembourg, L-2420
	Not yet recruiting
Luxembourg, Luxembourg, L-1361
	Recruiting
Luxembourg, Luxembourg, L-1611
	Recruiting
Niedercorn (Differdange), Luxembourg, L-4602
	Not yet recruiting
Luxembourg, Luxembourg, L-2449

Sponsors and Collaborators

Wyeth

Innovex, Inc

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881-101343
Study First Received:	September 12, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00195338
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009