End of the APPROACH clinical study

The final visit for the last participant in APPROACH was performed on the 1^st of April 2021. This marked the formal end of the APPROACH study and was performed within the official timeframe of the project.

More than two years ago, our clinical representatives enrolled a total of 297 participants in the APPROACH clinical study. Out of this number, 242 have completed the final M024 clinical visit. During the course of the APPROACH project, 48 participants withdrew from the study. Importantly, the sanitary crisis caused by the COVID-19 pandemic inevitably impacted the willingness of participants to visit their local hospitals for the APPROACH study. For this reason, 14 participants did not attend their visits (respectively 3 and 11 participants for M012 and M024). However, data and questionnaires could be obtained remotely for 7 of these participants at M024. Moreover, MRI imaging - an important outcome measurement for the APPROACH study, was performed for 238 participants, out of the total 242 who completed the 2-years follow-up.

Following the official end of the APPROACH study all participating clinical sites had two weeks to enter the data collected during the M024 visits into the eCRF, to share the images collected with the central readers and to send questionnaires for entering this data in the eCRF database. A process of data cleaning was installed between the 5 clinical sites in France, The Netherlands, Norway, Spain and the data management department of Servier. An internal process of data review will take place in Servier later in May. This process will ensure a seamless final data transfer to the consortium at the beginning of June.

In the meantime, consortium researchers and central readers are occupied with the reading and analysis of all images and analyses of the biosamples, collected during the APPROACH study clinical visits. In fact, the quantitative and qualitative MRI and X-ray readings are almost finished and the other analyses will follow soon.