FREE-study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

19 Sep 2024 → ongoing

Decision date (initial)

2024-09-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516277-68-00

EudraCT number

2020-001811-26

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Therapy, Efficacy

To evaluate whether an FC 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 objectives 2

1. To evaluate the effectiveness of anti-TNF re-escalation after failure of dosing interval lengthening in patients with IBD in sustained remission.
2. To estimate the cumulative incidence of anti-TNF associated adverse effects after dosing interval lengthening compared with an unchanged dosing interval.

Conditions and MedDRA coding

Crohn's disease Ulcerative colitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Aged 12-25 years
2. Diagnosed with luminal Crohn’s disease or ulcerative colitis
3. Treated with either 8-weekly infliximab or 2-weekly adalimumab
4. 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
5. No previous attempts to lengthen the dosing interval
6. Three consecutive faecal calprotectin (FC) 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)
7. Absence of symptoms associated with active IBD (judged by the local IBD-team)
8. Written informed consent granted

Exclusion criteria 5

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The cumulative incidence of out-of-range FC results at 48 weeks follow-up

Secondary endpoints 5

1. time to get out-of-range FC results, defined as the time from study baseline until the first out-of-range FC result
2. cumulative incidence of anti-TNF-associated respiratory infections and dermatological adverse effects (skin infections, new-onset or worsening of psoriasis, eczema, erythema nodosum, pyoderma gangrenosum, seborrheic dermatitis and other skin, hair or nail abnormalities) 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Patrick van Rheenen

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Patrick van Rheenen

Locations

3 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications