Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

Crohn Disease Clinical Trial

— STATIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03261206
• Other study ID #: RP1610
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 20, 2017
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Alimentiv Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 334
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Remission

Intervention

Other:
• 5-ASA Withdrawal
Withdrawal of 5-ASA therapy

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Dr. Jesse Siffledeen Professional Medical Corporation	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	McGill University Healthcare	Montréal	Quebec
Canada	Scott Shulman Medical Professional Corporation	North Bay	Ontario
Canada	Taunton Surgical Center	Oshawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	(G.I.R.I.) GI Research Institute	Vancouver	British Columbia
Canada	Discovery Clinical Services Ltd.	Victoria	British Columbia
Canada	Dr. O. Tarabain Medicine Professional Corporation	Windsor	Ontario
Canada	University of Manitoba - Health Sciences Centre	Winnipeg	Manitoba
Italy	IRCCA De Bellis	Castellana Grotte	Via Turi
Italy	Luigi Vanvitelli of Campania	Catania
Italy	Intituto Clinico Humanitas	Milano
Italy	Azienda Ospedale-Universita Padova	Padova
Italy	Campus Bio-Medico University of Rome	Roma
Italy	UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali	Roma	Rome
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan Italy
Ukraine	BYK - Kyiv	Kyiv
Ukraine	Danylo Halytsky Lviv National Medical University	Lviv
Ukraine	Odesa Regional Clinical Hospital	Odesa
Ukraine	Ternopil University Hospital	Ternopil
Ukraine	Vinnytsia Nation Medical University N.I. Pirogov	Vinnytsia
United Kingdom	Barnsley Hospital NHS Trust	Barnsley	Yorkshire
United Kingdom	Basildon and Thurrock University Hospitals NHS Foundation Trust	Basildon	Essex
United Kingdom	Bedford Hospital NHS Trust	Bedford
United Kingdom	Royal Blackburn Hospital	Blackburn	Lancashire
United Kingdom	Northern Care Alliance NHS Group - Fairfield General Hospital	Bury
United Kingdom	West Suffolk Hospital	Bury St Edmunds
United Kingdom	Darlington Memorial Hospital	Darlington	Durham
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter
United Kingdom	St. Marks Hospital	Harrow	Middlesex
United Kingdom	Guy's and St. Thomas' Hospitals NHS Trust	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Luton and Dustable Hospital Foundation Trust	Luton
United Kingdom	Nottingham University Hospitals NHS Trust and University of Nottingham	Nottingham
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	Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital	Sutton In Ashfield	Nottinghamshire
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust	Warrington	Cheshire

Sponsors (2)

Lead Sponsor	Collaborator
Alimentiv Inc.	Academic Medical Organization of Southwestern Ontario

Countries where clinical trial is conducted

Canada,  Italy,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD-related complications at 2 years	CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication	24 months
Secondary	CD-related complications at 1 year	CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication	12 months
Secondary	CD-related or CD-treatment related surgeries at 1 year		12 months
Secondary	CD-related or CD-treatment related surgeries at 2 years		24 months
Secondary	CD-related or CD-treatment related hospitalizations at 1 year		12 months
Secondary	CD-related or CD-treatment related hospitalizations at 2 years		24 months
Secondary	Other CD-related or CD-treatment related complications at 1 year	Other complication excludes surgeries or hospitalizations	12 months
Secondary	Other CD-related or CD-treatment related complications at 2 years	Other complication excludes surgeries or hospitalizations	24 months
Secondary	Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year		12 months
Secondary	Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years		24 months
Secondary	Time to first CD-related complication	CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication	up to 24 months
Secondary	Change in disease activity at 6 months	Disease activity assessed by HBI score	6 months
Secondary	Change in disease activity at 12 months	Disease activity assessed by HBI score	12 months
Secondary	Change in disease activity at 24 months	Disease activity assessed by HBI score	24 months
Secondary	Change in self-assessed quality of life at 6 months	Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item	Base line and 6 months
Secondary	Change in self-assessed quality of life at 1 year	Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item	Base line and 12 months
Secondary	Change in self-assessed quality of life at 2 years	Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item	Base line and 24 months
Secondary	Change in C-reactive protein concentration at 6 months		Base line and 6 months
Secondary	Change in C-reactive protein concentration at 1 year		Base line and 12 months
Secondary	Change in C-reactive protein concentration at 2 years		Base line and 24 months
Secondary	Change in fecal calprotectin concentration at 1 year		Base line and 12 months
Secondary	Change in fecal calprotectin concentration at 2 years		Base line and 24 months
Secondary	Change in CD-related drug treatment costs at 2 years	Estimated drug treatment costs before and after enrollment	12 months prior to enrollment and 24 months after enrollment
Secondary	Change in CD-related and total healthcare costs at 2 years	Estimated costs before and after enrollment	12 months prior to enrollment and 24 months after enrollment