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Health Outcomes in Rheumatoid Arthritis (HORA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346411
First Posted: June 29, 2006
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Outcomes in Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Enrollment: 164
Actual Study Start Date: September 1, 2005
Study Completion Date: December 12, 2011
Primary Completion Date: December 12, 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed with rheumatoid arthritis and receiving treatment for this condition from a rheumatologist
Criteria

Inclusion Criteria:

  • Males and females age 19 or older
  • Current active, adult-onset rheumatoid arthritis who meet American College of Rheumatology (ACR) criteria for RA and have: (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 a Johns Hopkins rheumatologist)
  • Enrolled in study evaluating efficacy of new or existing RA medications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346411


Locations
United States, Maryland
Johns Hopkins Bayview Campus
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Susan Bartlett, PhD Johns Hopkins School of Medicine
Principal Investigator: Cynthia S Rand, PhD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00346411     History of Changes
Other Study ID Numbers: NA_00001359
First Submitted: June 28, 2006
First Posted: June 29, 2006
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by Johns Hopkins University:
rheumatoid arthritis
mood
adherence
medication

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases