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NCT03261206CompletedPhase 4

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
334 (actual)
First submitted
22 Aug 2017
Start date
20 Nov 2017
Primary completion date
29 Jun 2026
Lead sponsor
Alimentiv Inc.
NCT number
NCT03261206

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 334
  • From 20 Nov 2017 to the primary completion date, 29 Jun 2026
  • 46 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
  • Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
  • Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment
  • Currently participating in another interventional trial, or previous participation within the last 3 months

Other illness

  • A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
  • A diagnosis of short-bowel syndrome
  • Active perianal disease
  • Active fistulizing disease
  • Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
  • History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures

Other

  • Unwillingness to stop taking aminosalicylates for the duration of the trial
  • Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment

Who the study is looking for

  • Documented diagnosis of CD at least 3 months prior to enrollment
  • Taking any brand or dosage of an oral aminosalicylate for at least 6 months
  • Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
  • CD currently in clinical remission
  • Able to participate fully in all aspects of the clinical trial
  • Written informed consent obtained and documented

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Of Calgary
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
University of Alberta
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EdmontonCanadaUnknown status
Dr. Jesse Siffledeen Professional Medical Corporation
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EdmontonCanadaUnknown status
London Health Sciences Centre, University Hospital
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LondonCanadaUnknown status
McGill University Healthcare
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MontrealCanadaUnknown status
Scott Shulman Medical Professional Corporation
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North BayCanadaUnknown status
Taunton Surgical Center
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OshawaCanadaUnknown status
Mount Sinai Hospital
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TorontoCanadaUnknown status
(G.I.R.I.) GI Research Institute
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VancouverCanadaUnknown status
Discovery Clinical Services Ltd
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VictoriaCanadaUnknown status
Dr. O. Tarabain Medicine Professional Corporation
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WindsorCanadaUnknown status
University of Manitoba, Health Sciences Centre
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WinnipegCanadaUnknown status
Barnsley Hospital NHS Trust
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BarnsleyUnited KingdomUnknown status
Basildon and Thurrock University Hospitals NHS Foundation Trust
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BasildonUnited KingdomUnknown status
Bedford Hospital NHS Trust
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BedfordUnited KingdomUnknown status
Royal Blackburn Hospital
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BlackburnUnited KingdomUnknown status
Southmead Hospital -North Bristol NHS Trust
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BristolUnited KingdomUnknown status
Northern Care Alliance NHS Group - Fairfield General Hospital
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BuryUnited KingdomUnknown status
West Suffolk Hospital
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Bury St EdmundsUnited KingdomUnknown status
ESNEFT Colchester Gen Hospital
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ColchesterUnited KingdomUnknown status
Darlington Memorial Hospital
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DarlingtonUnited KingdomUnknown status
Dudley Group NHS Foundation Trust
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DudleyUnited KingdomUnknown status
Royal Devon and Exeter NHS Foundation Trust
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ExeterUnited KingdomUnknown status
St. Marks Hospital
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HarrowUnited KingdomUnknown status
University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
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LeicesterUnited KingdomUnknown status
Royal Free Hospital
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LondonUnited KingdomUnknown status
Guy's and St Thomas' Hospitals NHS Trust
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LondonUnited KingdomUnknown status
Luton and Dustable Hospital Foundation Trust
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LutonUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust and University of Nottingham
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NottinghamUnited KingdomUnknown status
Royal Berkshire NHS Foundation Trust
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ReadingUnited KingdomUnknown status
Salford Ryal NHS Foundation Trust
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SalfordUnited KingdomUnknown status
Airedale NHS Foundation Trust
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SteetonUnited KingdomUnknown status
Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital
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Sutton in AshfieldUnited KingdomUnknown status
Warrington and Halton Hospitals NHS Foundation Trust
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WarringtonUnited KingdomUnknown status
IRCCS De Bellis
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Castellana GrotteItalyUnknown status
Luigi Vanvitelli of Campania
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CataniaItalyUnknown status
Ospedale San Raffaele S.r.I.
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MilanItalyUnknown status
Intituto Clinico Humanitas
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MilanItalyUnknown status
Azienda Ospedale Universita Padova
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PadovaItalyUnknown status
UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali
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RomaItalyUnknown status
Campus Bio-Medico University of Rome
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RomaItalyUnknown status
IRCCS Policlinico San Donato
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San Donato MilaneseItalyUnknown status
BYK - Kyiv
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KyivUkraineUnknown status
Danylo Halytsky Lviv National Medical University
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LvivUkraineUnknown status
Odesa Regional Clinical Hospital
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OdesaUkraineUnknown status
Ternopil University Hospital
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TernopilUkraineUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.