Health Outcomes in Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2006 by Johns Hopkins University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00346411

First received: June 28, 2006

Last updated: NA

Last verified: May 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 28, 2006

Last Updated Date

June 28, 2006

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Health Outcomes in Rheumatoid Arthritis

Official Title ^ICMJE

Health Outcomes in Rheumatoid Arthritis

Brief Summary

This research is being done to help us learn about how different factors related to treatment affect rheumatoid arthritis (RA). This is not a treatment study. We will follow the patient for one year as he or she receives usual treatment from his or her rheumatologist. Up to 360 adults with RA may join this study.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Additional Descriptors: Psychosocial
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

260

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females age 19 or older
Current active, adult-onset rheumatoid arthritis who meet ACR criteria for RA and have: (American College of Rheumatology [ACR] functional class I–III), defined as:
3 or more swollen or tender joints and
Morning stiffness of 45min or longer
OR judged by their rheumatologist to have active disease
No evidence of other inflammatory diseases (e.g., Crohn’s, IBS)
Functional class I, II or III

Exclusion Criteria:

Individuals with significant cardiovascular disease (CHF, stroke, MI)
Unwilling to have medications monitored and/or comply with protocol
Not fluent in English
Planning to move from area within next year or change health insurance (which would preclude ongoing care by JH rheumatologist)
Enrolled in study evaluating efficacy of new or existing RA medications

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Steffany Haaz, MFA	(410) 550-5216	shaaz1@jhmi.edu
Contact: Susan Bartlett, PhD	(410) 550-7775	bartlett@jhmi.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00346411

Other Study ID Numbers ^ICMJE

NA_00001359

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Susan Bartlett, PhD	Johns Hopkins School of Medicine
Study Director:	Steffany Haaz, MFA	Johns Hopkins University

Information Provided By

Johns Hopkins University

Verification Date

May 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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