Maxime Verhoeven

106 Chapter 6 that during follow-up, bDMARD use would further increase in the MTX initiation strategy group and further decrease in the TCZ initiation strategy groups. METHODS This was an observational open label multicentre 3-year post-trial follow-up (PTFU) of the U-Act-Early trial. Post-trial treatment was left to the discretion of the treating rheumatologist and patients were followed during routine clinical practice, which had a focus on treat-to-target. Patients who participated in the U-Act-Early trial were eligible for participation and were asked to participate at the end of U-Act-Early between Q2 2012 and Q3 2014. The only exclusion criteria were being lost-to-follow up, unwillingness to give informed consent and having had too many serious protocol violations (e.g., >4 times non- adherence to protocol over a period of 1 year). Nineteen of the initial 21 hospitals in the Netherlands participating in the U-Act-Early trial also participated in the PTFU. Detailed information on the U-Act-Early trial has been reported. 10 Data collection After the initial monthly follow-up during the U-Act-Early trial, in the PTFU period data was collected every 3 months in the first year and every 6 months thereafter up to 3 years. At every visit, all components of DAS28, physical function with the Dutch Health Assessment Questionnaire (HAQ) and information on use of non-steroidal anti- inflammatory drugs (NSAIDs), GCs, csDMARDs and bDMARDs were assessed, next to the occurrence of adverse events (AE) and, serious AE (SAE). Remission was defined as DAS28 <2.6 AND ≤4 swollen joints of 28 assessed joints, and SR was defined as being in remission for ≥24 weeks. Sustained drug free remission (sDFR) was defined as having tapered and stopped all DMARDs AND being in remission for ≥3 months. Radiographs from baseline U-Act-Early, end of U-Act-Early (2 years) and last available time point (5 years or end of follow-up) were scored in chronological order by an experienced professional reader, according to the Sharp van der Heijde (SvdH) method. To make optimal use of available x-rays, if the x-ray was not taken at the 5 year time point, but ≥3 year, the 5 year progression was estimated by extrapolation using the following formula; change SvdH score between baseline and last available x-ray/(date last available x-ray– date baseline x-ray/365)*5. The institutional review boards of the participating centers confirmed that the Medical Research Involving Human Subjects Act (WMO) was not applicable to this study, and all patients gave written informed consent.