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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03261206
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
Academic Medical Organization of Southwestern Ontario
Information provided by (Responsible Party):
Alimentiv Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn Disease Remission Other: 5-ASA Withdrawal Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. CD-related or CD-treatment related surgeries at 1 year [ Time Frame: 12 months ]
  3. CD-related or CD-treatment related surgeries at 2 years [ Time Frame: 24 months ]
  4. CD-related or CD-treatment related hospitalizations at 1 year [ Time Frame: 12 months ]
  5. CD-related or CD-treatment related hospitalizations at 2 years [ Time Frame: 24 months ]
  6. Other CD-related or CD-treatment related complications at 1 year [ Time Frame: 12 months ]
    Other complication excludes surgeries or hospitalizations

  7. Other CD-related or CD-treatment related complications at 2 years [ Time Frame: 24 months ]
    Other complication excludes surgeries or hospitalizations

  8. Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year [ Time Frame: 12 months ]
  9. Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years [ Time Frame: 24 months ]
  10. 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

  11. Change in disease activity at 6 months [ Time Frame: 6 months ]
    Disease activity assessed by HBI score

  12. Change in disease activity at 12 months [ Time Frame: 12 months ]
    Disease activity assessed by HBI score

  13. Change in disease activity at 24 months [ Time Frame: 24 months ]
    Disease activity assessed by HBI score

  14. 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

  15. 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

  16. 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

  17. Change in C-reactive protein concentration at 6 months [ Time Frame: Base line and 6 months ]
  18. Change in C-reactive protein concentration at 1 year [ Time Frame: Base line and 12 months ]
  19. Change in C-reactive protein concentration at 2 years [ Time Frame: Base line and 24 months ]
  20. Change in fecal calprotectin concentration at 1 year [ Time Frame: Base line and 12 months ]
  21. Change in fecal calprotectin concentration at 2 years [ Time Frame: Base line and 24 months ]
  22. 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

  23. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261206


Contacts
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Contact: Heather MacAulay 226-270-7683 heather.macaulay@alimentiv.com
Contact: Vipul Jairath, MD (226) 270-7683 ext 1027 vipul.jairath@robartsinc.com

Locations
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Sponsors and Collaborators
Alimentiv Inc.
Academic Medical Organization of Southwestern Ontario
Investigators
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Principal Investigator: Vipul Jairath, MD Western University; London Health Sciences Centre
Principal Investigator: Gordon Moran, MD University of Nottingham
More Information
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Responsible Party: Alimentiv Inc.
ClinicalTrials.gov Identifier: NCT03261206    
Other Study ID Numbers: RP1610
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases