Long-term Observation of Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Long-term Observation of Patients With Early Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240136
• Other study ID #: 91-10-435-32
• Status: Completed
• Start date: January 1993
• Est. completion date: October 23, 2020

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

See Publications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 ser — View Citation

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 radiogra — View Citation

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 arthr — View Citation

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 Rheumatol — View Citation

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. — View Citation

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 seropositi — View Citation

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): — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of joint erosions in the early stages of RA	Measure joint erosions over time	Baseline, Annual Follow-up