Long-term Observation of Patients With Early Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT00240136
• Recruitment Status: Completed
• First Posted: October 17, 2005
• Last Update Posted: November 17, 2020
• Sponsor: University of California, Los Angeles
• 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
• 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 *

• 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.
• 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.
• 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.
• 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.
• 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].
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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

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