In Phase 1, we found that the proportion of low-risk patients that experience a relapse of CD after stopping anti-TNF therapy (> 6 months stable) was 28% at 1 year of follow-up. The proportion of low risk patients who experience a relapse of CD…
ID
Bron
Verkorte titel
Aandoening
Crohn's Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint is a documented relapse of CD or CD complications, which necessitates medical or surgical intervention.
A relapse of luminal CD is defined as:
- Clinical relapse; HBI ≥ 5, on two consecutive measurements, with two weeks between both measurements, AND
- Biochemical relapse; FCP ≥ 250 µg/g on two consecutive measurements, with two weeks between both measurements, OR
- Endoscopic relapse; ulcerations on endoscopy.
CD complications include the following:
- Active fistula
- Perianal abscess
- Extra-intestinal manifestations, including but not limited to pyoderma gangrenosum, erythema nodosum.
Achtergrond van het onderzoek
In the Netherlands, approximately 25-30% of Crohn’s Disease (CD) patients receive anti-TNF therapy (infliximab or adalimumab). Despite the positive effects of anti-TNF treatment on the disease course, long-term anti-TNF treatment can lead to severe side effects such as infections, infusion reactions and possibly increased risk of melanoma. Furthermore, biologicals such as anti-TNF are rather expensive, especially since CD patients are treated long-term and clear stop-criteria are not available to date. The CEASE project has been designed to develop, validate and implement a diagnostic tool to safely cease anti-TNF therapy in CD patients. In phase 0 of the CEASE trial, the diagnostic tool was developed by using a IPD-MA. Subsequently, this model has been externally validated in a retrospective Dutch cohort. In this trial, we will assess the prognostic performance of the diagnostic tool to predict a relapse. For this, we will perform a multicentre, centre-specific stepped wedge randomized controlled trial. The participating centres will be randomly assigned to three groups, which will implement the anti-TNF stop strategy with the CEASE tool at three different time points. In the first part of the trial, patients will continue their treatment as usual (control group) with a follow-up time of either 6, 12 or 18 months. In the second part of the trial, a new group of patients will stop their anti-TNF therapy (intervention group) and these will have a follow-up time of 18, 12 or 6 months, with respect to the cluster the hospital has been randomized to.
Doel van het onderzoek
In Phase 1, we found that the proportion of low-risk patients that experience a relapse of CD after stopping anti-TNF therapy (> 6 months stable) was 28% at 1 year of follow-up. The proportion of low risk patients who experience a relapse of CD with continuous anti-TNF therapy (>1 year stable) is unknown; we expect it to be around 13% per year by using the diagnostic tool.
Onderzoeksopzet
Screening, baseline, 3, 6, 9, 12, 15, 18 months
(However, this depends on the cluster the hospital has been randomized to; subjects with 6 months follow up will have their last visit at 6 months, etc.)
Onderzoeksproduct en/of interventie
Cessation of anti-TNF
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Anti-TNF therapy ≥12 months
2. For low risk: Relapse risk < 33.3% after cessation of anti-TNF as predicted by the CEASE tool (‘low risk’, see Appendix 2).
3. Age ≥ 16 years.
4. Ability and willingness to give informed consent.
5. Luminal CD as indication for anti-TNF therapy.
6. Duration of anti-TNF treatment ≥ 12 months and a stable dose ≥ 3 months.
7. Concomitant therapy with an immunosuppressant is allowed (stable dose ≥ 3 months) and will be continued after withdrawal of anti-TNF medication during the study period.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Ulcerative colitis or IBD-unclassified
2. Co-morbidities that are a contraindication for (dis)continuing anti-TNF therapy
3. Corticosteroid use for luminal CD 6 months prior to inclusion
4. Ongoing pregnancy or planned pregnancy for the duration of the study
5. In the opinion of the investigator, the participant is incapable of understanding and complying with protocol requirements.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8891 |
| Ander register | METC Erasmus MC : MEC-2020-0575 |