Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

Study Overview
=================
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.

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.

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

Conditions
-----------------
Crohn Disease, Remission

Intervention / Treatment
-----------------
* Other: 5-ASA Withdrawal


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 5-ASA Continuation<br>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<br>Half of the subjects will discontinue their aminosalicylate therapy | Other: 5-ASA Withdrawal<br>* Withdrawal of 5-ASA therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| CD-related or CD-treatment related surgeries at 1 year |  | 12 months | 
| CD-related or CD-treatment related surgeries at 2 years |  | 24 months | 
| CD-related or CD-treatment related hospitalizations at 1 year |  | 12 months | 
| CD-related or CD-treatment related hospitalizations at 2 years |  | 24 months | 
| Other CD-related or CD-treatment related complications at 1 year | Other complication excludes surgeries or hospitalizations | 12 months | 
| Other CD-related or CD-treatment related complications at 2 years | 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 |  | 12 months | 
| Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years |  | 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 | up to 24 months | 
| Change in disease activity at 6 months | Disease activity assessed by HBI score | 6 months | 
| Change in disease activity at 12 months | Disease activity assessed by HBI score | 12 months | 
| Change in disease activity at 24 months | Disease activity assessed by HBI score | 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 | 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 | 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 | Base line and 24 months | 
| Change in C-reactive protein concentration at 6 months |  | Base line and 6 months | 
| Change in C-reactive protein concentration at 1 year |  | Base line and 12 months | 
| Change in C-reactive protein concentration at 2 years |  | Base line and 24 months | 
| Change in fecal calprotectin concentration at 1 year |  | Base line and 12 months | 
| Change in fecal calprotectin concentration at 2 years |  | Base line and 24 months | 
| 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 | 
| 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 |