STATIC: Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

Sponsor

Alimentiv Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT03261206

Collaborator

Academic Medical Organization of Southwestern Ontario (Other)

1,580

Enrollment

Locations

Arms

70.3

Anticipated Duration (Months)

34.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Nov 20, 2017

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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

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

Primary Outcome Measures

CD-related complications at 2 years [24 months]
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication

Secondary Outcome Measures

CD-related complications at 1 year [12 months]
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
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 [12 months]
Other complication excludes surgeries or hospitalizations
Other CD-related or CD-treatment related complications at 2 years [24 months]
Other complication excludes surgeries or hospitalizations
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 [up to 24 months]
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Change in disease activity at 6 months [6 months]
Disease activity assessed by HBI score
Change in disease activity at 12 months [12 months]
Disease activity assessed by HBI score
Change in disease activity at 24 months [24 months]
Disease activity assessed by HBI score
Change in self-assessed quality of life at 6 months [Base line and 6 months]
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in self-assessed quality of life at 1 year [Base line and 12 months]
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in self-assessed quality of life at 2 years [Base line and 24 months]
Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
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 [12 months prior to enrollment and 24 months after enrollment]
Estimated drug treatment costs before and after enrollment
Change in CD-related and total healthcare costs at 2 years [12 months prior to enrollment and 24 months after enrollment]
Estimated costs before and after enrollment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary	Calgary	Alberta	Canada	T2N 4Z6
2	University of Alberta	Edmonton	Alberta	Canada	T6G 2X8
3	Dr. Jesse Siffledeen Professional Medical Corporation	Edmonton	Alberta	Canada	T6L 6K3
4	(G.I.R.I.) GI Research Institute	Vancouver	British Columbia	Canada	V5Z 2K5
5	Discovery Clinical Services Ltd.	Victoria	British Columbia	Canada	V8T 5G4
6	PerCuro Clinical Research Ltd.	Victoria	British Columbia	Canada	V8V 3M9
7	University of Manitoba - Health Sciences Centre	Winnipeg	Manitoba	Canada	R3A 1R9
8	McMaster University	Hamilton	Ontario	Canada	L8S 4K1
9	London Health Sciences Centre - University Hospital	London	Ontario	Canada	N6A 5A5
10	Scott Shulman Medical Professional Corporation	North Bay	Ontario	Canada	P1B2H3
11	Taunton Surgical Center	Oshawa	Ontario	Canada	L1H 7K4
12	Mount Sinai Hospital	Toronto	Ontario	Canada	M5T 3L9
13	Dr. O. Tarabain Medicine Professional Corporation	Windsor	Ontario	Canada	N8W 1E6
14	McGill University Healthcare	Montréal	Quebec	Canada	N6A 5B6
15	IRCCS Policlinico San Donato	San Donato Milanese	Milan Italy	Italy	20097
16	UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali	Roma	Rome	Italy	00135
17	IRCCA De Bellis	Castellana Grotte	Via Turi	Italy	27-70013
18	Luigi Vanvitelli of Campania	Catania		Italy	95123
19	Intituto Clinico Humanitas	Milano		Italy	20089
20	Azienda Ospedale-Universita Padova	Padova		Italy	35128
21	Campus Bio-Medico University of Rome	Roma		Italy	00128
22	BYK - Kyiv	Kyiv		Ukraine	01030
23	Danylo Halytsky Lviv National Medical University	Lviv		Ukraine	79059
24	Odesa Regional Clinical Hospital	Odesa		Ukraine	65025
25	Ternopil University Hospital	Ternopil		Ukraine	46002
26	Vinnytsia Nation Medical University N.I. Pirogov	Vinnytsia		Ukraine	21018
27	Warrington and Halton Hospitals NHS Foundation Trust	Warrington	Cheshire	United Kingdom	WA5 1QG
28	Darlington Memorial Hospital	Darlington	Durham	United Kingdom	DL3 6HX
29	Basildon and Thurrock University Hospitals NHS Foundation Trust	Basildon	Essex	United Kingdom	SS16 5NL
30	Royal Blackburn Hospital	Blackburn	Lancashire	United Kingdom	BB2 3HH
31	St. Marks Hospital	Harrow	Middlesex	United Kingdom	HA1 3UJ
32	Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital	Sutton In Ashfield	Nottinghamshire	United Kingdom	NG17 4JL
33	Barnsley Hospital NHS Trust	Barnsley	Yorkshire	United Kingdom	S75 2EP
34	Bedford Hospital NHS Trust	Bedford		United Kingdom	MK42 9DJ
35	West Suffolk Hospital	Bury St Edmunds		United Kingdom	IP33 2QZ
36	Northern Care Alliance NHS Group - Fairfield General Hospital	Bury		United Kingdom	BL9 7TD
37	Addenbrooke's NHS	Cambridge		United Kingdom	CB2 0QQ
38	Royal Devon and Exeter NHS Foundation Trust	Exeter		United Kingdom	EX2 5DW
39	Royal Free Hospital	London		United Kingdom	Nw3 2QG
40	Guy's and St. Thomas' Hospitals NHS Trust	London		United Kingdom	SE1 7EH
41	Luton and Dustable Hospital Foundation Trust	Luton		United Kingdom	LU4 0DZ
42	Nottingham University Hospitals NHS Trust and University of Nottingham	Nottingham		United Kingdom	NG7 2UH
43	Royal Berkshire NHS Foundation Trust	Reading		United Kingdom	RG1 5AN
44	Salford Ryal NHS Foundation Trust	Salford		United Kingdom	M6 8HD
45	Airedale NHS Foundation Trust	Steeton		United Kingdom	BD20 6TD
46	Royal Hampshire County Hospital	Winchester		United Kingdom	SO22 5DG

Sponsors and Collaborators

Alimentiv Inc.
Academic Medical Organization of Southwestern Ontario

Investigators

Principal Investigator: Vipul Jairath, MD, Western University; London Health Sciences Centre
Principal Investigator: Gordon Moran, MD, University of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alimentiv Inc.

ClinicalTrials.gov Identifier:

NCT03261206

Other Study ID Numbers:

RP1610

First Posted:

Aug 24, 2017

Last Update Posted:

Apr 5, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Crohn Disease

Study Results

No Results Posted as of Apr 5, 2021