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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 : July 8, 2019
Sponsor:
Collaborator:
Academic Medical Organization of Southwestern Ontario
Information provided by (Responsible Party):
Robarts Clinical Trials 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.

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.


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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 : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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




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



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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

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

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: Lee A Williamson 226-270-7674 Leeanne.williamson@robartsinc.com
Contact: Vipul Jairath, MD (226) 270-7683 ext 1027 vipul.jairath@robartsinc.com

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Nima Hamidi       nima.hamidi@ucalgary.ca   
Contact: Heather Baylis       hbaylis@ucalgary.ca   
Sub-Investigator: Remo Panaccione, MD         
Principal Investigator: Christopher Ma, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Contact: Reed Sutton    780-248-1035    rtsutton@ualberta.ca   
Principal Investigator: Richard Fedorak, MD         
Dr. Jesse Siffledeen Professional Medical Corporation Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Contact: Christie Cor       christie.cor@sedmgastro.ca   
Principal Investigator: Jesse Sifledden, MD         
Canada, British Columbia
(G.I.R.I.) GI Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 2K5
Contact: Maria Schmidt       maria.a.schmit@gmail.com   
Principal Investigator: Gregory Rosenfeld, MD         
Discovery Clinical Services Ltd. Recruiting
Victoria, British Columbia, Canada, V8T 5G4
Contact: Lisa Warke       lwarke@dresearch.ca   
Contact: Kelly Curtis       kcurtis@dresearch.ca   
Principal Investigator: Denis Petrunia         
PerCuro Clinical Research Ltd. Completed
Victoria, British Columbia, Canada, V8V 3M9
Canada, Manitoba
University of Manitoba - Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Adebanke Oketola    204-787-4741 ext 1643    adebanke.oketola@umanitoba.ca   
Principal Investigator: Laura Targownik, MD         
Principal Investigator: Harminder Singh, MD         
Canada, Ontario
McMaster University Completed
Hamilton, Ontario, Canada, L8S 4K1
London Health Sciences Centre - University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Heather Prins    519-685-8500 ext 33344    heather.prins@lhsc.on.ca   
Contact: Tricia Leavens    519-685-8500 ext 35992    tricia.leavens@lhsc.ca   
Principal Investigator: Melanie Beaton, MD         
Scott Shulman Medical Professional Corporation Completed
North Bay, Ontario, Canada, P1B2H3
Taunton Surgical Center Recruiting
Oshawa, Ontario, Canada, L1H 7K4
Contact: Alana Carter       alanacarter01@gmail.com   
Principal Investigator: Daniel M. Green         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5T 3L9
Contact: Justine McLeod       Justine.Mcleod@sinaihealthsystem.ca   
Principal Investigator: Geoffrey Nguyen         
Dr. O. Tarabain Medicine Professional Corporation Recruiting
Windsor, Ontario, Canada, N8W 1E6
Contact: Michelle Marcon    519-915-4456    ml.marcon@hotmail.com   
Principal Investigator: Osman Tarabain, MD         
Canada, Quebec
McGill University Healthcare Recruiting
Montréal, Quebec, Canada, N6A 5B6
Contact: Jennifer Laneuville       jennifer.laneuville@muhc.mcgill.ca   
Contact: Carolyne Lemieux       carolune.lemieux@muhc.mcgill.ca   
Principal Investigator: Talat Bessissow         
United Kingdom
Northern Car Alliance NHS Group - Fairfield General Hospital Recruiting
Bury, United Kingdom, BL9 7TD
Contact: Ruth Craddock    0161 788 8720    ruth.craddock@pat.nhs.uk   
Principal Investigator: Jimmy K Limdi, MD         
Addenbrooke's NHS Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Kostantina Strongili       konstantina.strongili@addenbrookes.nhs.uk   
Principal Investigator: Miles Parkes, MD         
Royal Devon and Exeter NHS Foundation Trust Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Suzie Marriott       suzie.marriott@nhs.net   
Principal Investigator: Tariq Ahmad, MD         
Luton and Dustable Hospital Foundation Trust Withdrawn
Luton, United Kingdom, LU4 0DZ
Nottingham University Hospitals NHS Trust and University of Nottingham Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Shellie Radford, RN    0115 9249924 ext 60604    Shellie.Radford@nuh.nhs.uk   
Principal Investigator: Gordon Moran, MD         
Royal Berkshire NHS Foundation Trust Not yet recruiting
Reading, United Kingdom, RG1 5AN
Contact: Susanna Malkakorpi    118 322 6973    susanna.malkakorpi@royalberkshire.nhs.uk   
Principal Investigator: Aminda De Silva, MD         
Airedale NHS Foundation Trust Recruiting
Steeton, United Kingdom, BD20 6TD
Contact: Emma Dooks    01535 292279    Emma.Dooks@anhst.nhs.uk   
Principal Investigator: Richard Shenderey, MD         
Royal Hampshire County Hospital Withdrawn
Winchester, United Kingdom, SO22 5DG
Sponsors and Collaborators
Robarts Clinical Trials 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

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Responsible Party: Robarts Clinical Trials Inc.
ClinicalTrials.gov Identifier: NCT03261206     History of Changes
Other Study ID Numbers: RP1610
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
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
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents