A Phase 4 interventional study of 5-ASA Withdrawal in Crohn Disease and Remission, sponsored by Alimentiv Inc.. Completed at 46 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Alimentiv Inc. · Phase 4, Interventional, and Health services research
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.
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's enrollment of 334 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Alimentiv Inc. is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
Half of the subjects will discontinue their aminosalicylate therapy
Other: 5-ASA Withdrawal
Withdrawal of 5-ASA therapy
CD-related complications at 2 years
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Time frame: 24 months
CD-related complications at 1 year
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Time frame: 12 months
CD-related or CD-treatment related surgeries at 1 year
Time frame: 12 months
CD-related or CD-treatment related surgeries at 2 years
Time frame: 24 months
CD-related or CD-treatment related hospitalizations at 1 year
Time frame: 12 months
CD-related or CD-treatment related hospitalizations at 2 years
Time frame: 24 months
Other CD-related or CD-treatment related complications at 1 year
Other complication excludes surgeries or hospitalizations
Time frame: 12 months
Other CD-related or CD-treatment related complications at 2 years
Other complication excludes surgeries or hospitalizations
Time frame: 24 months
Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year
Time frame: 12 months
Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years
Time frame: 24 months
Time to first CD-related complication
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Time frame: up to 24 months
Change in disease activity at 6 months
Disease activity assessed by HBI score
Time frame: 6 months
Change in disease activity at 12 months
Disease activity assessed by HBI score
Time frame: 12 months
Change in disease activity at 24 months
Disease activity assessed by HBI score
Time frame: 24 months
Change in self-assessed quality of life at 6 months
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Time frame: Base line and 6 months
Change in self-assessed quality of life at 1 year
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Time frame: Base line and 12 months
Change in self-assessed quality of life at 2 years
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Time frame: Base line and 24 months
Change in C-reactive protein concentration at 6 months
Time frame: Base line and 6 months
Change in C-reactive protein concentration at 1 year
Time frame: Base line and 12 months
Change in C-reactive protein concentration at 2 years
Time frame: Base line and 24 months
Change in fecal calprotectin concentration at 1 year
Time frame: Base line and 12 months
Change in fecal calprotectin concentration at 2 years
Time frame: Base line and 24 months
Change in CD-related drug treatment costs at 2 years
Estimated drug treatment costs before and after enrollment
Time frame: 12 months prior to enrollment and 24 months after enrollment
Change in CD-related and total healthcare costs at 2 years
Estimated costs before and after enrollment
Time frame: 12 months prior to enrollment and 24 months after enrollment
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jun 2026, 103 months.
Of 54 non-industry phase 4 interventional studies under Crohn Disease, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 71. This study's 103 months is above that.
Counting every sponsor, half of 70 studies reached it within 56 months; a quarter within 35 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Alimentiv Inc.