Study Comparing Satisfaction and Perceptions for Two Different Delivery Mechanisms for Rheumatoid Arthritis Patients Administered Etanercept

This study has been completed.

First Received: December 20, 2007 Last Updated: June 2, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00595452

Purpose

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, 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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Enrollment:	264
Study Start Date:	November 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 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
2: Active Comparator Arm 2: Enbrel 50 mg Autoinjector	Device: Etanercept Autoinjector

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: NCT00595452

Show 35 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881K1-3329
Study First Received:	December 20, 2007
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00595452 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Rheumatoid Arthritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions

Musculoskeletal Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Immunoglobulin G
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010