Background/Purpose:  RCT are the gold standard for therapeutic efficacy, yet many studies indicate most patients seen in routine clinical care do not meet inclusion criteria. Apart from cultural challenges to the enrollment of ethnic minorities in clinical studies, decreased access and care, and late presentation in disease course may preclude inclusion in RA RCT. However, eligibility of ethnic minorities for RA RCT, to the best of our knowledge, has not been reported. EMRAC is a prospective clinical registry that collects data reflective of routine clinical care.  In this study, we evaluated the applicability of standard RCT inclusion criteria in a cohort of ethnic minority RA patients.

Methods: Enrollment data collected on EMRAC patients include socio-demographic parameters (age, gender, tobacco use), RA disease status variables (disease duration, serology [RF, ACPA], nodules, erosions, MDHAQ, TJC, SJC, ESR, CRP, CDAI, DAS28, RAPID3), treatments (prednisone, DMARD, Biologic therapies) and comorbidities (HTN, DM, HLD). RA related disease measures were evaluated for the following standard, high disease activity, RCT inclusion criteria: swollen joints (28) >= 6, tender joints (28) >= 6, ESR >= 28, morning stiffness >= 45 min. We also evaluated the cohort for low disease activity, defined as swollen (28) <= 1, tender (28) <= 1, ESR <= 10, morning stiffness <= 15 min. Comparisons were made of each individual criteria, high (RCT eligible) versus low disease activity, and overall RCT eligibility by Race (Caucasian, African American) using Chi-square test.

Results: 242 EMRAC patients had complete datasets available for analysis: 81 (33%) were Caucasian and 161 (67%) were African American (AA). The mean age was 62.5 years and the mean disease duration was 13.2 years. Only 4% AA and 4% Caucasians met standard RCT inclusion criteria, despite only 4% AA and 7% of Caucasians meeting criteria for low disease activity. The most stringent criterion was swollen joint count, with only 17% of AA and 15% of Caucasians meeting criteria, followed by tender joint counts (24% of AA and 32% of Caucasians).  52% AA and 40% Caucasian patients, respectively, met ESR criteria, while 38% AA and 37% Caucasians met morning stiffness thresholds.  Caucasians were more likely to have low disease activity ESR than AA (27% vs 11%, p=0.002), while AA had low disease activity tender (28) compared to Caucasians (58% vs 43%, p=0.032).

Conclusion:  In addition to reported socio-economic and cultural hurdles that preclude enrollment of ethnic minorities in RCT, African Americans, like their Caucasian counterparts, also fail to meet eligibility for RCT despite active disease, despite half as many African Americans as Caucasians achieving low disease status. These data may suggest reconsideration of current entry criteria for RCT in all patients with RA.