Long-term Observation of Patients With Early Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Harold E. Paulus, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00240136
First received: October 13, 2005
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
The purpose of this research is to observe the effects of RA over a long period in order to learn which of the early characteristics of patients' early RA predict future joint damage and disability. We also investigate whether certain treatments can prevent or slow the development of joint damage and disability. Additionally, the costs and effects of RA on the patient are studied in order to improve the methods used to measure these effects. Clinical, demographic, radiographic, and laboratory measures are taken by the rheumatologist in the office. In addition, patient questionnaires are mailed & completed by the patient and returned to the coordinating center at UCLA. All information obtained by these means will be studied in their effects on early, severe RA.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Long-term Observation of Patients With Early Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Development of joint erosions in the early stages of RA [ Time Frame: Baseline, Annual Follow-up ] [ Designated as safety issue: No ]
    Measure joint erosions over time


Enrollment: 372
Study Start Date: January 1993
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Detailed Description:
See Publications
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with rheumatoid arthritis
Criteria

Inclusion Criteria:

  • >=6 swollen joints & >=9 tender joints
  • symmetrical rheumatoid arthritis (RA)
  • <= 2 years worth of symptoms
  • rheumatoid factor seropositivity

Exclusion Criteria:

  • <18 years old
  • Inability to see rheumatologist, complete questionnaires (lack of compliance)
  • >2 years worth of symptoms
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240136

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Harold E Paulus, MD University of California, Los Angeles
  More Information

Publications:

Responsible Party: Harold E. Paulus, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00240136     History of Changes
Other Study ID Numbers: 91-10-435-32 
Study First Received: October 13, 2005
Last Updated: February 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Early, severe

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

ClinicalTrials.gov processed this record on August 30, 2016