A prospective, open randomized, parallel-Group study to evaluate the outcome of discontinuing vs. continuing anti-TNF in UC patients in remiss.
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.
- 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.
- To assess the efficacy and safety of restarting anti-TNF treatment after a relapse.
- 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
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 every university hospitals participating and all medium and large size gastroenterology centres in Norway. All principal investigators are experienced in anti-TNF and other immunosuppressive treatment in inflammatory bowel disease.
Other cooperating partners
The study will be organized and conducted in close cooperation with Norwegian Clinical Research Infrastructures Network (NORCRIN) and Unit for Applied Clinical Research (AKF) at the Norwegian University of Science and Technology (NTNU). So far both Sigrun Sæther* in NORCRIN and Ingrid Riphagen* in AKF has contributed in the design and outlining of patient consent form and protocol.