BIOSTOP

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.

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

Published Sep. 28, 2017 12:01 PM - Last modified Jan. 3, 2018 12:48 PM

Participants

  • Ingrid Prytz Berset
  • Knut Lundin
  • Bjørn Moum
  • Frode Lerang
  • Dag Arne Lihaug Hoff
  • Tore Grimstad
  • Jørgen Jahnsen
  • Nils Bolstad
  • Eivind Ness-Jensen
  • Johan Lunding
  • Inge Christoffer Olsen
  • Lars-Petter Jellness -Jørgensen
  • Lise Drægebø
  • Cathrine Haga Hartveit
  • Hilde Von Volkmann
  • Camilla Bondevik
  • Per Førde Refsnes
  • Friedemann Erchinger
  • Torun Rutle
  • Ellen Melsom
  • Unni Rasmussen
  • Hege Ekholm
  • Esben Midelfart Riise
  • Stine Røstberg
  • Øystein Hovlid
  • Eva Iren Halse
  • Synnøve Herje
  • Ingrid Prytz Berset
  • Bjørn Gulbrandsen
  • Synnøve Yksnøy
  • Synnøve Louise Aure
  • Elisabeth T. Bjerkan
  • Katarina Mølsæter
  • Tor Åge Myklebust
  • Beate Bremnes
  • Kristin Helen Besseberg
  • Merethe Seglem
  • Mathis Heibert
  • Torbjørn Øvreness
  • John Sebit Yobuta
  • Bente Marie Bekkavik
  • Heidi Soleng
  • Jørgen Valeur/Finn Strøm
  • Trond Smedsrud
  • Nina Flatner
  • Cecilie Moe
  • Carina Hinrichs
  • Rolf A. Klaasen
  • Hanne Degerud
  • Silje Kim Forsberg
  • Vendel Kristensen
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