Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
- Conditions
- Crohn DiseaseRemission
- Interventions
- Other: 5-ASA Withdrawal
- Registration Number
- NCT03261206
- Lead Sponsor
- Alimentiv Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 334
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5-ASA Withdrawal 5-ASA Withdrawal Half of the subjects will discontinue their aminosalicylate therapy
- Primary Outcome Measures
Name Time Method CD-related complications at 2 years 24 months CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
- Secondary Outcome Measures
Name Time Method Change in C-reactive protein concentration at 6 months Base line and 6 months CD-related or CD-treatment related surgeries at 1 year 12 months CD-related or CD-treatment related hospitalizations at 1 year 12 months Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year 12 months Time to first CD-related complication up to 24 months CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
CD-related or CD-treatment related hospitalizations at 2 years 24 months Other CD-related or CD-treatment related complications at 1 year 12 months Other complication excludes surgeries or hospitalizations
Other CD-related or CD-treatment related complications at 2 years 24 months Other complication excludes surgeries or hospitalizations
Change in self-assessed quality of life at 2 years Base line and 24 months Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in CD-related and total healthcare costs at 2 years 12 months prior to enrollment and 24 months after enrollment Estimated costs before and after enrollment
Change in disease activity at 6 months 6 months Disease activity assessed by HBI score
CD-related complications at 1 year 12 months CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Change in disease activity at 24 months 24 months Disease activity assessed by HBI score
Change in disease activity at 12 months 12 months Disease activity assessed by HBI score
Change in self-assessed quality of life at 6 months Base line and 6 months Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
CD-related or CD-treatment related surgeries at 2 years 24 months Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years 24 months Change in self-assessed quality of life at 1 year Base line and 12 months Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in C-reactive protein concentration at 1 year Base line and 12 months Change in CD-related drug treatment costs at 2 years 12 months prior to enrollment and 24 months after enrollment Estimated drug treatment costs before and after enrollment
Change in C-reactive protein concentration at 2 years Base line and 24 months Change in fecal calprotectin concentration at 2 years Base line and 24 months Change in fecal calprotectin concentration at 1 year Base line and 12 months
Trial Locations
- Locations (42)
Danylo Halytsky Lviv National Medical University
🇺🇦Lviv, Ukraine
Vinnytsia Nation Medical University N.I. Pirogov
🇺🇦Vinnytsia, Ukraine
Basildon and Thurrock University Hospitals NHS Foundation Trust
🇬🇧Basildon, Essex, United Kingdom
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Milan Italy, Italy
Intituto Clinico Humanitas
🇮🇹Milano, Italy
University of Manitoba - Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Dr. O. Tarabain Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
McGill University Healthcare
🇨🇦Montréal, Quebec, Canada
Luigi Vanvitelli of Campania
🇮🇹Catania, Italy
Warrington and Halton Hospitals NHS Foundation Trust
🇬🇧Warrington, Cheshire, United Kingdom
London Health Sciences Centre - University Hospital
🇨🇦London, Ontario, Canada
Campus Bio-Medico University of Rome
🇮🇹Roma, Italy
(G.I.R.I.) GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali
🇮🇹Roma, Rome, Italy
IRCCA De Bellis
🇮🇹Castellana Grotte, Via Turi, Italy
St. Marks Hospital
🇬🇧Harrow, Middlesex, United Kingdom
Scott Shulman Medical Professional Corporation
🇨🇦North Bay, Ontario, Canada
Azienda Ospedale-Universita Padova
🇮🇹Padova, Italy
Taunton Surgical Center
🇨🇦Oshawa, Ontario, Canada
Northern Care Alliance NHS Group - Fairfield General Hospital
🇬🇧Bury, United Kingdom
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Barnsley Hospital NHS Trust
🇬🇧Barnsley, Yorkshire, United Kingdom
Bedford Hospital NHS Trust
🇬🇧Bedford, United Kingdom
West Suffolk Hospital
🇬🇧Bury St Edmunds, United Kingdom
Luton and Dustable Hospital Foundation Trust
🇬🇧Luton, United Kingdom
Nottingham University Hospitals NHS Trust and University of Nottingham
🇬🇧Nottingham, United Kingdom
Darlington Memorial Hospital
🇬🇧Darlington, Durham, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust
🇬🇧London, United Kingdom
Royal Berkshire NHS Foundation Trust
🇬🇧Reading, United Kingdom
Salford Ryal NHS Foundation Trust
🇬🇧Salford, United Kingdom
Airedale NHS Foundation Trust
🇬🇧Steeton, United Kingdom
Discovery Clinical Services Ltd.
🇨🇦Victoria, British Columbia, Canada
BYK - Kyiv
🇺🇦Kyiv, Ukraine
Royal Devon and Exeter NHS Foundation Trust
🇬🇧Exeter, United Kingdom
Ternopil University Hospital
🇺🇦Ternopil, Ukraine
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Royal Blackburn Hospital
🇬🇧Blackburn, Lancashire, United Kingdom
Dr. Jesse Siffledeen Professional Medical Corporation
🇨🇦Edmonton, Alberta, Canada
Odesa Regional Clinical Hospital
🇺🇦Odesa, Ukraine
Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital
🇬🇧Sutton In Ashfield, Nottinghamshire, United Kingdom
University of Calgary
🇨🇦Calgary, Alberta, Canada