Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00459706

Purpose

The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Auto-injector and the Etanercept prefilled syringe) in patients with rheumatoid arthritis (RA).

Condition	Intervention	Phase
Active Rheumatoid Arthritis	Device: Etanercept Prefilled Syringe Device: Etanercept Autoinjector	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	A 3-Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore and Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector and The Etanercept Prefilled Syringe) in Patients With Rheumatoid Arthritis

Further study details as provided by Wyeth:

Primary Outcome Measures:

Perception and satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	534
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: Enbrel 50 mg Prefilled Syringe	Device: Etanercept Prefilled Syringe Enbrel 50 mg Prefilled Syringe once weekly
2: Active Comparator Arm 2: Enbrel 50 mg Autoinjector	Device: Etanercept Autoinjector Enbrel 50 mg Autoinjector once weekly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Diagnosis of RA according to the ACR-Criteria.
Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
Willing and able to self-inject etanercept.

Exclusion:

Prior experience of biologics and anti-TNF treatment for their RA including etanercept.
Sepsis or risk of sepsis.
Current or recent infections, including chronic or localized.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459706

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 113 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881K1-6000
Study First Received:	April 11, 2007
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00459706
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Antibodies
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Immunoglobulin G

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

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