Clinical trial NCT03261206: Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
Official title: Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Crohn Disease
Remission
Lead sponsor: Alimentiv Inc.
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
First posted: 2017-08-24
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD.

In this open-label, randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24 month period.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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
* 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
* 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
* Currently participating in another interventional trial, or previous participation within the last 3 months

Primary outcomes:
measure: CD-related complications at 2 years
timeFrame: 24 months
Secondary outcomes:
measure: CD-related complications at 1 year
timeFrame: 12 months
measure: CD-related or CD-treatment related surgeries at 1 year
timeFrame: 12 months
measure: CD-related or CD-treatment related surgeries at 2 years
timeFrame: 24 months
measure: CD-related or CD-treatment related hospitalizations at 1 year
timeFrame: 12 months
measure: CD-related or CD-treatment related hospitalizations at 2 years
timeFrame: 24 months
measure: Other CD-related or CD-treatment related complications at 1 year
timeFrame: 12 months
measure: Other CD-related or CD-treatment related complications at 2 years
timeFrame: 24 months
measure: Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year
timeFrame: 12 months
measure: Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years
timeFrame: 24 months
measure: Time to first CD-related complication
timeFrame: up to 24 months
measure: Change in disease activity at 6 months
timeFrame: 6 months
measure: Change in disease activity at 12 months
timeFrame: 12 months
measure: Change in disease activity at 24 months
timeFrame: 24 months
measure: Change in self-assessed quality of life at 6 months
timeFrame: Base line and 6 months
measure: Change in self-assessed quality of life at 1 year
timeFrame: Base line and 12 months
measure: Change in self-assessed quality of life at 2 years
timeFrame: Base line and 24 months
measure: Change in C-reactive protein concentration at 6 months
timeFrame: Base line and 6 months
measure: Change in C-reactive protein concentration at 1 year
timeFrame: Base line and 12 months
measure: Change in C-reactive protein concentration at 2 years
timeFrame: Base line and 24 months
measure: Change in fecal calprotectin concentration at 1 year
timeFrame: Base line and 12 months
measure: Change in fecal calprotectin concentration at 2 years
timeFrame: Base line and 24 months
measure: Change in CD-related drug treatment costs at 2 years
timeFrame: 12 months prior to enrollment and 24 months after enrollment
measure: Change in CD-related and total healthcare costs at 2 years
timeFrame: 12 months prior to enrollment and 24 months after enrollment
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Edmonton
country: Canada
facility: Dr. Jesse Siffledeen Professional Medical Corporation
state: Alberta
city: Vancouver
country: Canada
facility: (G.I.R.I.) GI Research Institute
state: British Columbia
city: Victoria
country: Canada
facility: Discovery Clinical Services Ltd.
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba - Health Sciences Centre
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: North Bay
country: Canada
facility: Scott Shulman Medical Professional Corporation
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Surgical Center
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Windsor
country: Canada
facility: Dr. O. Tarabain Medicine Professional Corporation
state: Ontario
city: Montréal
country: Canada
facility: McGill University Healthcare
state: Quebec
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan Italy
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.I.
state: Milan
city: Roma
country: Italy
facility: UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali
state: Rome
city: Castellana Grotte
country: Italy
facility: IRCCS De Bellis
state: Via Turi
city: Catania
country: Italy
facility: Luigi Vanvitelli of Campania
city: Milano
country: Italy
facility: Intituto Clinico Humanitas
city: Padova
country: Italy
facility: Azienda Ospedale-Universita Padova
city: Roma
country: Italy
facility: Campus Bio-Medico University of Rome
city: Kyiv
country: Ukraine
facility: BYK - Kyiv
city: Lviv
country: Ukraine
facility: Danylo Halytsky Lviv National Medical University
city: Odesa
country: Ukraine
facility: Odesa Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital
city: Warrington
country: United Kingdom
facility: Warrington and Halton Hospitals NHS Foundation Trust
state: Cheshire
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
state: Durham
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals NHS Foundation Trust
state: Essex
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
state: Lancashire
city: Harrow
country: United Kingdom
facility: St. Marks Hospital
state: Middlesex
city: Sutton In Ashfield
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital
state: Nottinghamshire
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Trust
state: Yorkshire
city: Bedford
country: United Kingdom
facility: Bedford Hospital NHS Trust
city: Bristol
country: United Kingdom
facility: Southmead Hospital, North Bristol NHS Trust
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital
city: Bury
country: United Kingdom
facility: Northern Care Alliance NHS Group - Fairfield General Hospital
city: Colchester
country: United Kingdom
facility: ESNEFT Colchester Gen Hospital
city: Dudley
country: United Kingdom
facility: Dudley Group NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospitals NHS Trust
city: Luton
country: United Kingdom
facility: Luton and Dustable Hospital Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust and University of Nottingham
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Salford Ryal NHS Foundation Trust
city: Steeton
country: United Kingdom
facility: Airedale NHS Foundation Trust
Study officials:
affiliation: Western University; London Health Sciences Centre
name: Vipul Jairath, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Gordon Moran, MD
role: PRINCIPAL_INVESTIGATOR
References: