Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Improving Clinical Trial Recruitment in a Real World Practice. Results From the Canadian Early Arthritis Cohort.
Akhavan1, Pooneh S., Bykerk2, Vivian, Sun3, Ye, Haraoui4, Boulos, Thorne5, J. Carter, Pope6, Janet E., Hitchon7, Carol A.
University of Toronto, Toronto, ON
Rebecca MacDonald Centre for Arthritis and Autoimmune Disease, Mount Sinai Hospital, Toronto, ON
Brigham & Women's Hospital, Boston, MA
Mount Sinai Hospital, Toronto, ON
Institut de Rhumatologie, Montreal, QC
Southlake Regional Health Centre, Newmarket, Newmarket, ON
St. Joseph's Health Care, University of Western Ontario, London, ON
University of Manitoba, Winnipeg, MB
CHUS - Sherbrooke University, Sherbrooke, QC
Current clinical trials are not representative of characteristics of patients in clinical practice. A minority of patients in clinical practice meet current entry criteria for most trials. The objective was to evaluate whether using more liberal clinical trial entry criteria in a real world clinical setting will generate clinical outcomes comparable to the use of 'standard' entry criteria and will improve clinical trial recruitment.
Patients with early RA enrolled in the Canadian early Arthritis Cohort (CATCH), were evaluated. Patients were included in present study if: Age >= 18, met ACR 1987 criteria, initiating MTX at baseline, had >= 6-month follow up, did not receive biologics and had available ACR responses. Disease activity was assessed at baseline and 24 weeks.
Two "standard" enrolment criteria were defined: 1) >= 6 TJC68 and >= 6 SJC66 with either an ESR >28 or CRP >1.5 mg/dl, 2) >= 6 TJC28 and >= 6 SJC28 with either an ESR >28 or CRP >1.5 mg/dl. Five "liberal" criteria were defined as: 1) SDAI >11, 2) DAS28 >3.2, 3) >= 6 TJC28 and >= 6 SJC28 + elevated ESR or CRP (ESR >20 or CRP>1), 4)>= 4 TJC28 and >= 4 SJC28 + ESR >28 or CRP >1.5 mg/dl, 5)>= 4 TJC28 and >= 4 SJC28 + elevated ESR or CRP(ESR >20 or CRP>1). Proportion of patients eligible for enrolment based on each criteria were compared, their baseline characteristics, ACR and EULAR responses were compared.
312 patients were eligible for analysis. Percentages of patients who met each inclusion criteria are demonstrated in table 1. Patients in the first two liberal groups had the lowest proportion of elevated ESR/CRP(41% and 42% compared to >70% in other groups). ACR50 response rate was 5657% in standard groups and 5355% in liberal groups (except group 3). EULAR response rate was comparable among various groups.
Table 1. Comparison of percentage of patients who met each enrolment criteria (n=312)
|Standard 1||Standard 2||Liberal 1||Liberal 2||Liberal 3||Liberal 4||Liberal 5|
|Met enrolment criteria (%)||33%||28%||90%||88%||32%||33%||40%|
Liberal trial entry criteria may improve recruitment from real world practice settings. Patients with a reduced joint count at entry (4 versus 6) and a greater than normal acute phase reactant were more likely to achieve the entry criteria with a significant proportion of patients having an elevated CRP. Entry criteria with 4 TJC28 and SJC28 with greater than normal acute phase reactant should be considered for future trials.
To cite this abstract, please use the following information:
Akhavan, Pooneh S., Bykerk, Vivian, Sun, Ye, Haraoui, Boulos, Thorne, J. Carter, Pope, Janet E., et al; Improving Clinical Trial Recruitment in a Real World Practice. Results From the Canadian Early Arthritis Cohort. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1889