A Prediction Model to Safely CEASE Anti-TNF Therapy in Patients with Crohn's Disease

Diagnostic tool to safely CEASE anti-TNF therapy in Crohn’s disease: a center-specific, stepped wedge Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25895

Enrollment

190

Registered

2020-09-15

Start date

2020-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Interventions

Cessation of anti-TNF

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
- Maintenance of remission, defined as a HBI < 5, FCP < 250 µg/g until the end of the follow-up period. - Signs of inflammation on endoscopy. - Time to relapse - Sustained low-risk for relapse according to the CEASE tool - Quality of Life: IBD-Q and EQ-5D-5L - Patient reported outcome: PRO2 - Total costs: drug costs, other health care costs (iMCQ), work productivity and produc-tivity loss (iPCQ).	—

Measure

Time frame

- Maintenance of remission, defined as a HBI < 5, FCP < 250 µg/g until the end of the follow-up period. - Signs of inflammation on endoscopy. - Time to relapse - Sustained low-risk for relapse according to the CEASE tool - Quality of Life: IBD-Q and EQ-5D-5L - Patient reported outcome: PRO2 - Total costs: drug costs, other health care costs (iMCQ), work productivity and produc-tivity loss (iPCQ).

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Contacts

Public ContactDjuna de Jong

Amsterdam UMC, location AMC

d.c.dejong@amsterdamumc.nl020-5661260

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)