Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study.

OBJECTIVES: To assess the efficacy and safety of certolizumab pegol (CZP)+dose-optimised methotrexate (MTX) versus placebo (PBO)+dose-optimised MTX in inducing and sustaining clinical remission in DMARD-naïve patients with moderate-to-severe, active, progressive rheumatoid arthritis (RA), with poor prognostic factors over 52 weeks. METHODS: DMARD-naïve patients with ≤1 year of active RA were randomised (3:1) in a double-blind manner to CZP (400 mg Weeks 0, 2, 4, then 200 mg Q2W to Week 52)+MTX or PBO+MTX (the mean optimised-MTX dose=21 and 22 mg/week, respectively). Sustained remission (sREM) and sustained low disease activity (sLDA; DAS28(ESR)<2.6 and DAS28(ESR)≤3.2, respectively, at both Weeks 40 and 52) were the primary and secondary endpoints. RESULTS: Patients were randomised to CZP+MTX (n=660) and PBO+MTX (n=219). At Week 52, significantly more patients assigned to CZP+MTX compared with PBO+MTX achieved sREM (28.9% vs 15.0%, p<0.001) and sLDA (43.8% vs 28.6%, p<0.001). Inhibition of radiographic progression and improvements in physical functioning were significantly greater for CZP+MTX versus PBO+MTX (van der Heijde modified total Sharp score (mTSS) mean absolute change from baseline (CFB): 0.2 vs 1.8, p<0.001, rate of mTSS non-progressors: 70.3% vs 49.7%, p<0.001; least squares (LS) mean CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI): -1.00 vs -0.82, p<0.001). Incidence of adverse events (AEs) and serious AEs was similar between treatment groups. Infection was the most frequent AE, with higher incidence for CZP+MTX (71.8/100 patient-years (PY)) versus PBO+MTX (52.7/100 PY); the rate of serious infection was similar between CZP+MTX (3.3/100 PY) and PBO+MTX (3.7/100 PY). CONCLUSIONS: CZP+dose-optimised MTX treatment of DMARD-naïve early RA resulted in significantly more patients achieving sREM and sLDA, improved physical function and inhibited structural damage compared with PBO+dose-optimised MTX. TRIAL REGISTRATION NUMBER: NCT01519791.

1994 athletic trainer employment and salary characteristics.

OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO DETERMINE: 1) demographics and professional credentials of recently hired athletic trainers, 2) the association between these characteristics and the high school, clinical, and collegiate setting, and 3) which of these factors best predicted salary. DESIGN AND SETTING: A survey was sent to all prospective employers. Of the 472 surveys sent, 282 (60%) were returned. SUBJECTS: Prospective employers who were listed on the NATA job vacancy notices from January 1, 1994 to October 1, 1994. MEASUREMENTS: Employers selected a job description for their position opening and indicated the characteristics of the people they hired. The job descriptions were placed into three categories. A chi-square analysis was used to determine the degree of association between applicant characteristics and job descriptions. Employee characteristics were coded and a stepwise multiple regression analysis was performed to determined which of the characteristics best predicted salary. Analyses of variance were performed to determine differences among the three practice settings and as follow-up analyses to the multiple regression. An analysis of variance was also performed to compare salaries based on job description and teaching responsibilities. RESULTS: No association was found between the employment setting and gender, ethnicity, marital status, educational route, physical therapy, credential, or EMT certification. There was an association between the CPR instructor's credential and employment setting and between highest degree attained and employment setting. CONCLUSIONS: The results suggest that these factors were most closely associated with employment in the collegiate setting. With regard to salary, it was determined that a doctoral degree, a master's degree, and marital status were the best predictors of salary.