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Crohn DiseasePhase 4STATICNCT03261206

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

A Phase 4 study testing 5-ASA Withdrawal in people with Crohn Disease and Remission, run by Alimentiv Inc. at 46 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease, Remission
What is being tested?
5-ASA Withdrawal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
46 sitesin 4 countries
Study dates
20 Nov 2017to 29 Jun 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

46 sites in 4 countries.

46 sites in 4 countries

United Kingdom22 sites

  • Barnsley Hospital NHS Trust

    Barnsley, Yorkshire, S75 2EP

  • Basildon and Thurrock University Hospitals NHS Foundation Trust

    Basildon, Essex, SS16 5NL

  • Bedford Hospital NHS Trust

    Bedford, MK42 9DJ

  • Royal Blackburn Hospital

    Blackburn, Lancashire, BB2 3HH

  • Southmead Hospital, North Bristol NHS Trust

    Bristol, BS10 5NB

  • Northern Care Alliance NHS Group - Fairfield General Hospital

    Bury, BL9 7TD

  • West Suffolk Hospital

    Bury St Edmunds, IP33 2QZ

  • ESNEFT Colchester Gen Hospital

    Colchester, CO4 3JA

  • Darlington Memorial Hospital

    Darlington, Durham, DL3 6HX

  • Dudley Group NHS Foundation Trust

    Dudley, DY1 2HQ

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • St. Marks Hospital

    Harrow, Middlesex, HA1 3UJ

  • University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Royal Free Hospital

    London, Nw3 2QG

  • Guy's and St. Thomas' Hospitals NHS Trust

    London, SE1 7EH

  • Luton and Dustable Hospital Foundation Trust

    Luton, LU4 0DZ

  • Nottingham University Hospitals NHS Trust and University of Nottingham

    Nottingham, NG7 2UH

  • Royal Berkshire NHS Foundation Trust

    Reading, RG1 5AN

  • Salford Ryal NHS Foundation Trust

    Salford, M6 8HD

  • Airedale NHS Foundation Trust

    Steeton, BD20 6TD

  • Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital

    Sutton in Ashfield, Nottinghamshire, NG17 4JL

  • Warrington and Halton Hospitals NHS Foundation Trust

    Warrington, Cheshire, WA5 1QG

Other trials in United Kingdom

Canada12 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • University of Alberta

    Edmonton, Alberta, L8S 4K1

  • Dr. Jesse Siffledeen Professional Medical Corporation

    Edmonton, Alberta, T6L 6K3

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • McGill University Healthcare

    Montreal, Quebec, N6A 5B6

  • Scott Shulman Medical Professional Corporation

    North Bay, Ontario, P1B2H3

  • Taunton Surgical Center

    Oshawa, Ontario, L1H 7K4

  • Mount Sinai Hospital

    Toronto, Ontario, M5T 3L9

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V5Z 2K5

  • Discovery Clinical Services Ltd.

    Victoria, British Columbia, V8T 5G4

  • Dr. O. Tarabain Medicine Professional Corporation

    Windsor, Ontario, N8W 1E6

  • University of Manitoba - Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Italy8 sites

  • IRCCS De Bellis

    Castellana Grotte, Via Turi, 27-70013

  • Luigi Vanvitelli of Campania

    Catania, 95123

  • Ospedale San Raffaele S.r.I.

    Milan, Milan, 20132

  • Intituto Clinico Humanitas

    Milan, 20089

  • Azienda Ospedale-Universita Padova

    Padova, 35128

  • UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali

    Roma, Rome, 00135

  • Campus Bio-Medico University of Rome

    Roma, 00128

  • IRCCS Policlinico San Donato

    San Donato Milanese, Milan Italy, 20097

Other trials in Italy

Ukraine4 sites

  • BYK - Kyiv

    Kyiv, 01030

  • Danylo Halytsky Lviv National Medical University

    Lviv, 79059

  • Odesa Regional Clinical Hospital

    Odesa, 65025

  • Ternopil University Hospital

    Ternopil, 46002

Other trials in Ukraine

About this study

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

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.

Read the 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.

Being tested
5-ASA Withdrawal
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-ASA WithdrawalOther

    Withdrawal of 5-ASA therapy

Study groups in NCT03261206
Study groupRoleWhat they receive
5-ASA ContinuationNo interventionHalf of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
5-ASA WithdrawalExperimentalHalf of the subjects will discontinue their aminosalicylate therapy
Receives: Other: 5-ASA Withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CD-related complications at 2 years

    CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication

    Measured: 24 months

Secondary outcomes (23)

  1. CD-related complications at 1 year

    CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication

    Measured: 12 months

  2. CD-related or CD-treatment related surgeries at 1 year

    Measured: 12 months

  3. CD-related or CD-treatment related surgeries at 2 years

    Measured: 24 months

  4. CD-related or CD-treatment related hospitalizations at 1 year

    Measured: 12 months

  5. CD-related or CD-treatment related hospitalizations at 2 years

    Measured: 24 months

  6. Other CD-related or CD-treatment related complications at 1 year

    Other complication excludes surgeries or hospitalizations

    Measured: 12 months

  7. Other CD-related or CD-treatment related complications at 2 years

    Other complication excludes surgeries or hospitalizations

    Measured: 24 months

  8. Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year

    Measured: 12 months

  9. Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years

    Measured: 24 months

  10. Time to first CD-related complication

    CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication

    Measured: up to 24 months

  11. Change in disease activity at 6 months

    Disease activity assessed by HBI score

    Measured: 6 months

  12. Change in disease activity at 12 months

    Disease activity assessed by HBI score

    Measured: 12 months

  13. Change in disease activity at 24 months

    Disease activity assessed by HBI score

    Measured: 24 months

  14. Change in self-assessed quality of life at 6 months

    Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item

    Measured: Base line and 6 months

  15. Change in self-assessed quality of life at 1 year

    Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item

    Measured: Base line and 12 months

  16. Change in self-assessed quality of life at 2 years

    Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item

    Measured: Base line and 24 months

  17. Change in C-reactive protein concentration at 6 months

    Measured: Base line and 6 months

  18. Change in C-reactive protein concentration at 1 year

    Measured: Base line and 12 months

  19. Change in C-reactive protein concentration at 2 years

    Measured: Base line and 24 months

  20. Change in fecal calprotectin concentration at 1 year

    Measured: Base line and 12 months

  21. Change in fecal calprotectin concentration at 2 years

    Measured: Base line and 24 months

  22. Change in CD-related drug treatment costs at 2 years

    Estimated drug treatment costs before and after enrollment

    Measured: 12 months prior to enrollment and 24 months after enrollment

  23. Change in CD-related and total healthcare costs at 2 years

    Estimated costs before and after enrollment

    Measured: 12 months prior to enrollment and 24 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start20 Nov 2017
  3. Primary completion29 Jun 2026
  4. Study completion29 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03261206
Sponsor's protocol ID
RP1610
Acronym
STATIC
Status last verified
Oct 2026
First submitted
22 Aug 2017
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 5-ASA Withdrawal in people with Crohn Disease and Remission, run by Alimentiv Inc. at 46 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United Kingdom, Canada, Italy, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD-related complications at 2 years (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03261206.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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