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.
- Diseases
- Crohn's disease
- 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
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Dr. Jesse Siffledeen Professional Medical Corporation Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| London Health Sciences Centre, University Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill University Healthcare Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Scott Shulman Medical Professional Corporation Coordinator of this site? Confirm its status | North Bay | Canada | Unknown status |
| Taunton Surgical Center Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| (G.I.R.I.) GI Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Discovery Clinical Services Ltd Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
| Dr. O. Tarabain Medicine Professional Corporation Coordinator of this site? Confirm its status | Windsor | Canada | Unknown status |
| University of Manitoba, Health Sciences Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Barnsley Hospital NHS Trust Coordinator of this site? Confirm its status | Barnsley | United Kingdom | Unknown status |
| Basildon and Thurrock University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Basildon | United Kingdom | Unknown status |
| Bedford Hospital NHS Trust Coordinator of this site? Confirm its status | Bedford | United Kingdom | Unknown status |
| Royal Blackburn Hospital Coordinator of this site? Confirm its status | Blackburn | United Kingdom | Unknown status |
| Southmead Hospital -North Bristol NHS Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Northern Care Alliance NHS Group - Fairfield General Hospital Coordinator of this site? Confirm its status | Bury | United Kingdom | Unknown status |
| West Suffolk Hospital Coordinator of this site? Confirm its status | Bury St Edmunds | United Kingdom | Unknown status |
| ESNEFT Colchester Gen Hospital Coordinator of this site? Confirm its status | Colchester | United Kingdom | Unknown status |
| Darlington Memorial Hospital Coordinator of this site? Confirm its status | Darlington | United Kingdom | Unknown status |
| Dudley Group NHS Foundation Trust Coordinator of this site? Confirm its status | Dudley | United Kingdom | Unknown status |
| Royal Devon and Exeter NHS Foundation Trust Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| St. Marks Hospital Coordinator of this site? Confirm its status | Harrow | United Kingdom | Unknown status |
| University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' Hospitals NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Luton and Dustable Hospital Foundation Trust Coordinator of this site? Confirm its status | Luton | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust and University of Nottingham Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Royal Berkshire NHS Foundation Trust Coordinator of this site? Confirm its status | Reading | United Kingdom | Unknown status |
| Salford Ryal NHS Foundation Trust Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Airedale NHS Foundation Trust Coordinator of this site? Confirm its status | Steeton | United Kingdom | Unknown status |
| Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital Coordinator of this site? Confirm its status | Sutton in Ashfield | United Kingdom | Unknown status |
| Warrington and Halton Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Warrington | United Kingdom | Unknown status |
| IRCCS De Bellis Coordinator of this site? Confirm its status | Castellana Grotte | Italy | Unknown status |
| Luigi Vanvitelli of Campania Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Ospedale San Raffaele S.r.I. Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Intituto Clinico Humanitas Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Campus Bio-Medico University of Rome Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| IRCCS Policlinico San Donato Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Unknown status |
| BYK - Kyiv Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Danylo Halytsky Lviv National Medical University Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Odesa Regional Clinical Hospital Coordinator of this site? Confirm its status | Odesa | Ukraine | Unknown status |
| Ternopil University Hospital Coordinator of this site? Confirm its status | Ternopil | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.