Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

This study has been completed.

First Received on April 11, 2007. Last Updated on February 23, 2010 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

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

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

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

Show 113 Study Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00459706 History of Changes
Obsolete Identifiers:	NCT00595452
Other Study ID Numbers:	0881K1-6000
Study First Received:	April 11, 2007
Last Updated:	February 23, 2010
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Rheumatoid Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Immunoglobulin G
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012