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CompletedNCT00240136Updated Nov 17, 2020

Long-term Observation of Patients With Early Rheumatoid Arthritis

An observational study in Rheumatoid Arthritis, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by University of California, Los Angeles · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
372
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

See Publications

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Early, severe
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 372 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with rheumatoid arthritis

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \<18 years old
  • Inability to see rheumatologist, complete questionnaires (lack of compliance)
  • >2 years worth of symptoms
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
372 participants (actual)
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What researchers measure

Primary outcomes

  1. Development of joint erosions in the early stages of RA

    Measure joint erosions over time

    Time frame: Baseline, Annual Follow-up

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Study locations

1 site
  • UCLA
    Los Angeles, California 90095, United States
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References and documents

Publications

  • Cole JC, Motivala SJ, Khanna D, Lee JY, Paulus HE, Irwin MR. Validation of single-factor structure and scoring protocol for the Health Assessment Questionnaire-Disability Index. Arthritis Rheum. 2005 Aug 15;53(4):536-42. doi: 10.1002/art.21325. PubMed 16082630 ↗
  • Khanna D, Ranganath VK, Fitzgerald J, Park GS, Altman RD, Elashoff D, Gold RH, Sharp JT, Furst DE, Paulus HE; Western Consortium of Practicing Rheumatologists. Increased radiographic damage scores at the onset of seropositive rheumatoid arthritis in older patients are associated with osteoarthritis of the hands, but not with more rapid progression of damage. Arthritis Rheum. 2005 Aug;52(8):2284-92. doi: 10.1002/art.21221. PubMed 16052588 ↗
  • Ranganath VK, Elashoff DA, Khanna D, Park G, Peter JB, Paulus HE; Western consortium of practicing rhuemotologists. Age adjustment corrects for apparent differences in erythrocyte sedimentation rate and C-reactive protein values at the onset of seropositive rheumatoid arthritis in younger and older patients. J Rheumatol. 2005 Jun;32(6):1040-2. PubMed 15940764 ↗
  • Wu H, Khanna D, Park G, Gersuk V, Nepom GT, Wong WK, Paulus HE, Tsao BP. Interaction between RANKL and HLA-DRB1 genotypes may contribute to younger age at onset of seropositive rheumatoid arthritis in an inception cohort. Arthritis Rheum. 2004 Oct;50(10):3093-103. doi: 10.1002/art.20555. PubMed 15476205 ↗
  • Amjadi S, Khanna D, Park GS, Bulpitt KJ, Wong WK, Paulus HE. Dating the "window of therapeutic opportunity" in early rheumatoid arthritis: accuracy of patient recall of arthritis symptom onset. J Rheumatol. 2004 Sep;31(9):1686-92. Erratum In: J Rheumatol. 2011 Jan;38(1):183. Amjadi-Begvand, Sogol [corrected to Amjadi, Sogol]. PubMed 15338485 ↗
  • Paulus HE, Oh M, Sharp JT, Gold RH, Wong WK, Park GS, Bulpitt KJ; Western Consortium of Practicing Rheumatologists. Classifying structural joint damage in rheumatoid arthritis as progressive or nonprogressive using a composite definition of joint radiographic change: a preliminary proposal. Arthritis Rheum. 2004 Apr;50(4):1083-96. doi: 10.1002/art.20270. PubMed 15077290 ↗
  • Paulus HE, Oh M, Sharp JT, Gold RH, Wong WK, Park GS, Bulpitt KJ; Western Consortium of Praticing Rheumatologists. Correlation of single time-point damage scores with observed progression of radiographic damage during the first 6 years of rheumatoid arthritis. J Rheumatol. 2003 Apr;30(4):705-13. PubMed 12672187 ↗
  • Paulus HE, Wiesner J, Bulpitt KJ, Patnaik M, Law J, Park GS, Wong WK. Autoantibodies in early seropositive rheumatoid arthritis, before and during disease modifying antirheumatic drug treatment. J Rheumatol. 2002 Dec;29(12):2513-20. PubMed 12465144 ↗
  • Paulus HE, Bulpitt KJ, Ramos B, Park G, Wong WK; Western Consortium of Practicing Rheumatologists. Relative contributions of the components of the American College of Rheumatology 20% criteria for improvement to responder status in patients with early seropositive rheumatoid arthritis. Arthritis Rheum. 2000 Dec;43(12):2743-50. doi: 10.1002/1529-0131(200012)43:123.0.CO;2-A. PubMed 11145032 ↗
  • Newhall-Perry K, Law NJ, Ramos B, Sterz M, Wong WK, Bulpitt KJ, Park G, Lee M, Clements P, Paulus HE. Direct and indirect costs associated with the onset of seropositive rheumatoid arthritis. Western Consortium of Practicing Rheumatologists. J Rheumatol. 2000 May;27(5):1156-63. PubMed 10813281 ↗
  • Paulus HE, Ramos B, Wong WK, Ahmed A, Bulpitt K, Park G, Sterz M, Clements P. Equivalence of the acute phase reactants C-reactive protein, plasma viscosity, and Westergren erythrocyte sedimentation rate when used to calculate American College of Rheumatology 20% improvement criteria or the Disease Activity Score in patients with early rheumatoid arthritis. Western Consortium of Practicing Rheumatologists. J Rheumatol. 1999 Nov;26(11):2324-31. PubMed 10555885 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00240136
Lead sponsor
University of California, Los Angeles
Responsible party
Sponsor
First posted
Oct 17, 2005
Start date
Jan 1993
Primary completion
Oct 23, 2020
Completion
Oct 23, 2020
Last update
Nov 17, 2020

Study contacts

Harold E Paulus, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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