IBD under control with less medication

• Register: EUCTR
• Last refreshed on: 23 September 2024
• Main ID: EUCTR2020-001811-26-BE
• Date of registration: 22/07/2021
• Prospective Registration: Yes
• Primary sponsor: University Medical Center Groningen
• Public title: IBD under control with less medication
• Scientific title: De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study
• Date of first enrolment: 18/11/2021
• Target sample size: 148
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001811-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Partially randomised patient-preference trial If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: A different dosing interval of the same IMP Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, Netherlands, Spain

Contacts

• Name: Hiruz
• Affiliation: University Hospital Ghent

• Name: Hiruz
• Affiliation: University Hospital Ghent

Key inclusion & exclusion criteria

Inclusion criteria:
- Aged 12-25 years
- Diagnosed with luminal Crohn’s disease or ulcerative colitis
- Treated with either 8-weekly infliximab or 2-weekly adalimumab
- Current anti-TNF agent as first ever anti-TNF agent or prior anti-TNF agent discontinued for reason other than primary non-response or secondary loss-of-response
- No previous attempts to lengthen the dosing interval
- Three consecutive faecal calprotectin results in the target range (i.e. <250 µg/g for CD patients; <150 µg/g for UC patients) in the previous 6 months or confirmed endoscopic remission within 2 months before study entry (i.e. simple endoscopic score for Crohn’s disease (SES-CD) <3 points; ulcerative colitis endoscopic index of severity (UCEIS) =1 point or Mayo endoscopic subscore =1 point)
- Absence of symptoms associated with active IBD (judged by the local IBD-team)
- Writeen informed consent granted
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Perianal fistula
- Presence of ileostomy or ileoanal pouch (as FC cut-off is not validated for small bowel faeces)
- Any inflammatory comorbidity, such as rheumatoid arthritis
- Current treatment with corticosteroids (prednisone or budesonide)
- Current pregnancy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's disease, ulcerative colitis

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Flixabi
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Inflectra
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Remsima
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Zessly
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20-80

Trade Name: Amgevita
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 20-80

Trade Name: Hulio
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: range
Concentration n

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 48 weeks follow-up.

Primary end point(s): The cumulative incidence of out-of-range FC results at 48 weeks follow-up.

Secondary Objective: To evaluate the effectiveness of anti-TNF re-escalation after failure of dosing interval lengthening in patients with IBD in sustained remission.
Hypothesis: TNF re-escalation after failure of dosing interval lengthening is effective in bringing back FC levels into the target range in >90% of patients.

To estimate the cumulative incidence of anti-TNF associated adverse effects after dosing interval lengthening compared with an unchanged dosing interval.
Hypothesis: Anti-TNF dosing interval lengthening results in a decrease of anti-TNF-associated adverse effects.

Main Objective: To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.

Secondary Outcome(s)

Secondary end point(s): (1) time to get out-of-range FC results
(2) cumulative incidence of anti-TNF-associated respiratory infections and dermatological adverse effects at 48 weeks follow-up
(3) evolution of FC and anti-TNF trough levels in the first 16 weeks after reverting to previous dosing interval
(4) proportion of patients developing loss-of-response in the first 16 weeks after reverting to the previous dosing interval
(5) identification of predictors of successful de-escalation.

Timepoint(s) of evaluation of this end point: (1) -
(2) 48 weeks follow-up
(3) the first 16 weeks after reverting to previous dosing interval
(4) the first 16 weeks after reverting to the previous dosing interval
(5) -

Secondary ID(s)

NL73966.042.20

2020-001811-26-NL

Source(s) of Monetary Support

Buhlmann Laboratories AG

Ethics review

Status: Approved
Approval date: 18/11/2021
Contact: