title: Discontinuation of infliximab therapy in patients with Crohn's disease in sustained complete remission (the STOP IT study): protocol for a double-blind, randomised, placebo-controlled, multicentre trial.
abstract: BACKGROUND
  Infliximab (IFX), a monoclonal chimeric antibody against tumour necrosis factor (TNF) α, is effective for induction and maintenance of remission in moderate to severe Crohn's disease. Discontinuation of IFX maintenance therapy in patients in remission should be considered in order to reduce the potential long-term side effects and lower costs.
  
  
  METHODS
  This is a prospective, double-blind, randomised, placebo-controlled, multicentre study of patients with luminal Crohn's disease who have been treated with IFX for at least 1 year and are in sustained complete clinical, biochemical and endoscopic remission (ie, Crohn's Disease Activity Index (CDAI) score <150, complete mucosal healing and biochemical markers of inflammation within the normal range). These patients are randomised to receive placebo infusions or continue IFX maintenance therapy. The primary end point is the proportion of patients in maintained remission after 48 weeks (def. CDAI <150).
  
  
  BACKGROUND
  It is estimated that the knowledge gained about how to optimally handle patients with Crohn's disease in complete long-term sustained remission on IFX is proportionate to the risks and inconveniences related to participation in this study. Prolonged exposure to IFX may cause severe side effects and increased risk of malignancies. Conversely, IFX discontinuation should not unnecessarily create a high risk of relapse. Thus, empirical evidence is needed concerning the safety of discontinuing IFX once a patient exhibits sustained remission. Study results will be published in an English language scientific medical journal. The study is approved by the Danish Medicines Agency (EudraCT-number: 2012-002702-51) and the Regional Ethics Committee of Region Hovedstaden Denmark (Approval-number: H-4-2012-099). The project is reported to the Danish Data Protection Agency (ID-number: 2007-58-0015/HEH.750.89-27), registered at Clinicaltrials.gov, and monitored by independent GCP units for the University of Copenhagen, Odense and Aarhus. The current approved protocol is V.3.2, dated 1 June 2014.
  
  
  BACKGROUND
  http://clinicaltrials.gov/show/NCT01817426.
authors.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark.
authors.forename: Sine Schnoor
authors.initials: SS
authors.lastname: Buhl
authors.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark.
authors.forename: Casper
authors.initials: C
authors.lastname: Steenholdt
authors.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark.
authors.forename: Jørn
authors.initials: J
authors.lastname: Brynskov
authors.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark.
authors.forename: Ole Østergaard
authors.initials: OØ
authors.lastname: Thomsen
authors.affiliation: Institute for Inflammation Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Klaus
authors.initials: K
authors.lastname: Bendtzen
authors.affiliation: Department of Gastroenterology, Herlev Hospital, Herlev, Denmark.
authors.forename: Mark Andrew
authors.initials: MA
authors.lastname: Ainsworth
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069285:Infliximab; D060046:Maintenance Chemotherapy / Q000009:adverse effects / Q000706:statistics & numerical data; D008297:Male; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D012107:Research Design; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: GASTROENTEROLOGY