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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 23 November 2020
Main ID:  EUCTR2020-001811-26-NL
Date of registration: 08/07/2020
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: 30/09/2020
Target sample size: 150
Recruitment status: Authorised-recruitment may be ongoing or finished
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
Netherlands
Contacts
Name: Clinical Research Office   
Address:  Hanzeplein 1 9713 GZ Groningen Netherlands
Telephone: +310503615522
Email: Clinical-research-office@umcg.nl
Affiliation:  University Medical Center Groningen
Name: Clinical Research Office   
Address:  Hanzeplein 1 9713 GZ Groningen Netherlands
Telephone: +310503615522
Email: Clinical-research-office@umcg.nl
Affiliation:  University Medical Center Groningen
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
- Three consecutive faecal calprotectin results in the target range in the previous 6 months or confirmed endoscopic remission within 2 months before study entry
- Absence of symptoms associated with active IBD
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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
- Any inflammatory comorbidity, such as rheumatoid arthritis
- Current treatment with corticosteroids (prednisone or budesonide)


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)
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.
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.
Timepoint(s) of evaluation of this end point: 48 weeks follow-up.
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)
202000261
Source(s) of Monetary Support
Buhlmann Laboratories AG
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 30/09/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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