Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study

This study is currently recruiting participants.

Verified by Wyeth, November 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00794118

Purpose

The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only from subjects providing informed consent.

Condition
Rheumatoid Arthritis

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study

Further study details as provided by Wyeth:

Primary Outcome Measures:

Information collected from clinical documentation at baseline and/or within 1 month of study entry, and after approximately 3, 6, 9, and 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cost-evaluation of different patterns of anti-TNF adoption [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
A

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic

Criteria

Inclusion Criteria

Eighteen years of age or older
Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:
1. Morning stiffness in and around the joints lasting at least 1 hour;
2. Arthritis of 3 or more joint areas;
3. Arthritis of hand joints;
4. Symmetric arthritis. simultaneous involvement of the same joint areason both sides of the body;
5. Rheumatoid nodules;
6. Serum Rheumatoid Factor (RF)
7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
Patients naive to anti-TNF drugs
Outpatients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794118

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Italy
	Recruiting
Parma, Italy, 43100
Contact: trial manager decresg@wyeth.com
	Recruiting
San Vito dei Normanni, Italy, 87100
Contact: trial manager decresg@wyeth.com

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:	0881A1-102321
Study First Received:	November 17, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00794118
Health Authority:	Italy: Ethics Committee

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009