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Long-term Observation of Patients With Early Rheumatoid Arthritis

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.
 
ClinicalTrials.gov Identifier: NCT00240136
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Tracking Information
First Submitted Date October 13, 2005
First Posted Date October 17, 2005
Last Update Posted Date November 17, 2020
Study Start Date January 1993
Actual Primary Completion Date October 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2016)
Development of joint erosions in the early stages of RA [ Time Frame: Baseline, Annual Follow-up ]
Measure joint erosions over time
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Observation of Patients With Early Rheumatoid Arthritis
Official Title Long-term Observation of Patients With Early Rheumatoid Arthritis
Brief Summary 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.
Detailed Description See Publications
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with rheumatoid arthritis
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 17, 2016)
372
Original Enrollment
 (submitted: October 13, 2005)
400
Actual Study Completion Date October 23, 2020
Actual Primary Completion Date October 23, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00240136
Other Study ID Numbers 91-10-435-32
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University of California, Los Angeles
Original Responsible Party Not Provided
Current Study Sponsor University of California, Los Angeles
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Harold E Paulus, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date November 2020