Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC)

February 6, 2023 updated by: Alimentiv Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1580

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2X8
        • Recruiting
        • University of Alberta
        • Contact:
        • Principal Investigator:
          • Brendan Philip Halloran, MD
      • Edmonton, Alberta, Canada, T6L 6K3
        • Recruiting
        • Dr. Jesse Siffledeen Professional Medical Corporation
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2K5
        • Recruiting
        • (G.I.R.I.) GI Research Institute
      • Victoria, British Columbia, Canada, V8T 5G4
        • Completed
        • Discovery Clinical Services Ltd.
      • Victoria, British Columbia, Canada, V8V 3M9
        • Withdrawn
        • PerCuro Clinical Research Ltd.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Completed
        • University of Manitoba - Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Withdrawn
        • McMaster University
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre - University Hospital
      • North Bay, Ontario, Canada, P1B2H3
        • Completed
        • Scott Shulman Medical Professional Corporation
      • Oshawa, Ontario, Canada, L1H 7K4
        • Recruiting
        • Taunton Surgical Center
      • Toronto, Ontario, Canada, M5T 3L9
        • Completed
        • Mount Sinai Hospital
      • Windsor, Ontario, Canada, N8W 1E6
        • Recruiting
        • Dr. O. Tarabain Medicine Professional Corporation
    • Quebec
      • Montréal, Quebec, Canada, N6A 5B6
        • Recruiting
        • McGill University Healthcare
  • Italy
      • Catania, Italy, 95123
        • Recruiting
        • Luigi Vanvitelli of Campania
      • Milano, Italy, 20089
        • Recruiting
        • Intituto Clinico Humanitas
      • Padova, Italy, 35128
        • Not yet recruiting
        • Azienda Ospedale-Università Padova
      • Roma, Italy, 00128
        • Recruiting
        • Campus Bio-Medico University of Rome
    • Milan Italy
      • San Donato Milanese, Milan Italy, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
        • Contact:
          • Maria Laura Annuziata, MD
    • Rome
      • Roma, Rome, Italy, 00135
        • Recruiting
        • UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali
    • Via Turi
      • Castellana Grotte, Via Turi, Italy, 27-70013
        • Recruiting
        • IRCCA De Bellis
  • Ukraine
      • Kyiv, Ukraine, 01030
        • Recruiting
        • BYK - Kyiv
      • Lviv, Ukraine, 79059
        • Completed
        • Danylo Halytsky Lviv National Medical University
      • Odesa, Ukraine, 65025
        • Recruiting
        • Odesa Regional Clinical Hospital
      • Ternopil, Ukraine, 46002
        • Recruiting
        • Ternopil University Hospital
      • Vinnytsia, Ukraine, 21018
        • Not yet recruiting
        • Vinnytsia Nation Medical University N.I. Pirogov
  • United Kingdom
      • Bedford, United Kingdom, MK42 9DJ
        • Recruiting
        • Bedford Hospital NHS Trust
      • Bury, United Kingdom, BL9 7TD
        • Recruiting
        • Northern Care Alliance NHS Group - Fairfield General Hospital
      • Bury St Edmunds, United Kingdom, IP33 2QZ
        • Completed
        • West Suffolk Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Withdrawn
        • Addenbrooke's NHS
      • Exeter, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon and Exeter NHS Foundation Trust
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guy's and St. Thomas' Hospitals NHS Trust
      • Luton, United Kingdom, LU4 0DZ
        • Recruiting
        • Luton and Dustable Hospital Foundation Trust
      • Nottingham, United Kingdom, NG7 2UH
        • Recruiting
        • Nottingham University Hospitals NHS Trust and University of Nottingham
      • Reading, United Kingdom, RG1 5AN
        • Recruiting
        • Royal Berkshire NHS foundation trust
      • Salford, United Kingdom, M6 8HD
        • Recruiting
        • Salford Ryal NHS Foundation Trust
      • Steeton, United Kingdom, BD20 6TD
        • Recruiting
        • Airedale NHS Foundation Trust
      • Winchester, United Kingdom, SO22 5DG
        • Withdrawn
        • Royal Hampshire County Hospital
    • Cheshire
      • Warrington, Cheshire, United Kingdom, WA5 1QG
        • Recruiting
        • Warrington and Halton Hospitals NHS Foundation Trust
    • Durham
      • Darlington, Durham, United Kingdom, DL3 6HX
        • Recruiting
        • Darlington Memorial Hospital
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Recruiting
        • Basildon and Thurrock University Hospitals NHS Foundation Trust
    • Lancashire
      • Blackburn, Lancashire, United Kingdom, BB2 3HH
        • Completed
        • Royal Blackburn Hospital
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Recruiting
        • St. Marks Hospital
    • Nottinghamshire
      • Sutton In Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
        • Recruiting
        • Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital
    • Yorkshire
      • Barnsley, Yorkshire, United Kingdom, S75 2EP
        • Recruiting
        • Barnsley Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 5-ASA Continuation
Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
EXPERIMENTAL: 5-ASA Withdrawal
Half of the subjects will discontinue their aminosalicylate therapy
Other: 5-ASA Withdrawal
Withdrawal of 5-ASA therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD-related complications at 2 years
Time Frame: 24 months
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alimentiv Inc.

Collaborators

Academic Medical Organization of Southwestern Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2017

Primary Completion (ANTICIPATED)

June 1, 2026

Study Completion (ANTICIPATED)

June 1, 2026

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (ACTUAL)

August 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP1610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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