Upon completion of the eligibility screening, subjects were scheduled for the initial visit in the same week.
To decrease reporting bias, the study assistants will not provide further information about the purpose of the study until the completion of the eligibility screening.
Written informed consent will be obtained, followed by completion of additional eligibility questionnaires, including screening for angina, peripheral vascular disease (PVD), and severe depression.
It includes completion of additional eligibility questionnaires, measurement of height, weight, waist circumference, and resting blood pressure, and a fasting blood draw for tests of plasma glucose and lipids at the onsite Clinical Laboratory.
Following registration, confirmation of eligibility and completion of baseline assessments and questionnaires, participants will be randomised in a 1 1 1 ratio to receive alternative mechanism TNFi, abatacept or rituximab.
Following consent, determination of eligibility and completion of baseline measures, the coordinator alerts the Data Coordinating Center (DCC) electronically either via encrypted email or data uploads to a secure server.
Following signed consent, verbal confirmation of eligibility, and completion of baseline measures, the research assistant will log onto the randomization website, enter each participant's code number, and will receive the random group assignment.
After confirming eligibility and completion of baseline data collection, the Study Coordinator will contact the designated investigator (MST) for allocation.
Completion of online consent and preliminary eligibility screening requires potential participants to provide their full name and contact details, along with their date of birth, gender and confirmation of their regular access to an internet-enabled computer or device and availability to attend the Trial Coordinating Centre on at least four occasions.
Patients who are deemed appropriate for enrolment into the study will be randomised, following completion of the baseline data collection and confirmation of eligibility, to one of two trial arms control (StanC) or treatment (PREHAB).
