About the project
In the BIOSTOP Study ulcerative colitis patients in remission after at least one year anti-TNF maintenance therapy will be included. If clinical remission is confirmed by symptom score and faecal calprotectin, a full ileocolonoscopy is performed.
Mucosal healing defined as Mayo endoscopic score (MES) of 0-1 is the major inclusion criterion. Patients will be openly randomized to either discontinuing anti-TNF (intervention group) or continuing anti-TNF (control group) for 2 years.
During the randomization period, patients will be monitored by repeated symptom scoring and faecal calprotectin. If suspected relapse a rectosigmoidoscopy will be done, and if confirmed endoscopic relapse defined as MES > 1, anti-TNF therapy restarted. Patient Report Outcomeis registered once yearly, and at the end of the 2 year randomization period all patients will be thoroughly evaluated including a scheduled rectosigmoidoscopy. Control group patients, and intervention group patients who has restarted anti-TNF, will in addition be regularly monitored by anti-TNF drug concentration and antibody measurements.
Objectives
Primary objective
- To assess if discontinuing anti-TNF treatment in ulcerative colitis (UC) patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF therapy.
Secondary objective
- To assess the efficacy and safety of restarting anti-TNF treatment after a relapse.
Exploratory objectives
- To identify factors predictive for successful discontinuation of anti-TNF
- To identify factors predictive for successful restart of anti-TNF in patients experiencing a relapse
Resource utilization, cost-effectiveness and patients reported outcome objectives
- To assess UC-related events (hospitalizations, procedures),cost-effectiveness and effect on health-related quality of life (QoL) after two years of randomized treatmen
Collaboration
National coordinating center
Ingrid Prytz Berset is the national coordinating investigator of the BIOSTOP study. She is senior consultant gastroenterologist at Ålesund Hospital Møre & Romsdal (MR) Hospital Trust and is employed in a 50 % PhD grant position at Oslo University and MR Hospital Trust 2017-2023. During this 6 year period she will coordinate both the randomized part and the follow up part of the project. She will coordinate the study in close cooperation with the BIOSTOP Working Group at the Clinical research unit and R&D department MR Hospital Trust. Besides Ingrid Prytz Berset this group consists of her co-supervisor and head of the Clinical research unit Dag Arne Lihaug Hoff, national coordinating monitor Katarina Mølsæter, research nurses Synnøve Herje and Elisabeth Bjerkan, and research bioengineer Synnnøve Yksnøy. Berset’s main supervisor Knut Lundin at Oslo University and co-supervisor Frode Lerang at Østfold Hospital Trust will also be working in close cooperation with the PhD candidate and with the BIOSTOP Working Group at MR Hospital trust.
National cooperating centers and other cooperating partners
Hospitals and centers from all parts of Norway and all four health regions will participate in the BIOSTOP Study. Among the 28 participating centres are all the Norwegian University Hospitals and all medium and larger sized gastroenterology centers in Norway, as well as most of the smaller centers. All principal investigators are experienced in anti-TNF and other immunosuppressive treatment in inflammatory bowel disease. The study will be organized and conducted in cooperation with Norwegian Clinical Research Infrastructures Network (NORCRIN) at the Norwegian University of Science and Technology (NTNU). The electronic case report file is set up and maintained by Cecilie Moe at Unit for Applied Clinical Research (AKF) at Oslo University Hospital. Foundation for the randomized part of the study 2017 – 2021 is granted by the Norwegian Research Council and MR Hospital Trust, and also the last 2 years will be partially financed by MR Hospital Trust