Subcutaneous infliximab after a previous intravenous dose optimization (AMARETTO trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Belgian IBD Research and Development

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

29 Apr 2024 → ongoing

Decision date (initial)

2024-04-09

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Celltrion

External identifiers

EU CT number

2023-508166-15-00

ClinicalTrials.gov

NCT06113913

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To compare clinical and biological outcome between a regimen with subcutaneous infliximab every week and subcutaneous infliximab every other week among patients who were in clinical and biological remission with an optimized intravenous schedule when they switched to subcutaneous infliximab.

Secondary objectives 3

1. To compare treatment optimization and discontinuation between a regimen with SC infliximab every week and SC infliximab every other week among patients who were in clinical and biological remission with an optimized IV schedule when they switched to SC infliximab.
2. To evaluate the willingness and the experience of patients switching to SC infliximab.
3. To compare clinical and biological outcome, as well as treatment optimization and discontinuation between a regimen with SC infliximab (every week or every other week) and IV infliximab among patients who were in clinical and biological remission with an optimized IV schedule.

Conditions and MedDRA coding

Ulcerative colitis (UC), Inflammatory bowel disease type unclassified (IBDU) and Crohn's disease (CD)

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Patients with a previously documented CD, UC, IBDU diagnosis confirmed by clinical , endoscopic, histological, and/or radiological criteria.
2. Males and females ≥18 years old
3. Patients must be in steroid-free clinical remission at Screening defined as a rectal bleeding score of 0 and a stool frequency score of ≤1 for patients with UC / IBDU, or an average daily abdominal pain score ≤1 and a liquid stool frequency score ≤2.8 for patients with CD (based on the 3 days before the screening visit, excluding the day of or the day before an eventual endoscopy with bowel preparation) and this without the need for any type of steroids in the previous eight weeks.
4. Patients must be in biological remission at screening defined as a CRP <10 mg/L and a fecal calprotectin <250 µg/g.
5. Patients receiving IV infliximab for at least 26 consecutive weeks.
6. Patients receiving a stable IV dosing schedule for at least 20 weeks.
7. Patients receiving an average IV infliximab per eight weeks based on the two most recent IV administrations of more than 8 mg/kg, but not more than 22 mg/kg.
8. Patients who speak and read fluently Dutch, French or English.
9. Patients who is able to voluntary give their written informed consent.

Exclusion criteria 6

1. Male or female < 18 years
2. Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy (transient or permanent)
3. Patients participating in an interventional clinical trial with an Investigational Medicinal Product (IMP) or device.
4. Patients previously treated with subcutaneous infliximab.
5. Patients with active perianal fistulizing disease.
6. Patients with microscopic colitis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of patients that maintain steroid-free clinical and biological remission by week 52 without treatment optimization after switch to subcutaneous infliximab.

Secondary endpoints 19

1. The proportion of patients that maintain steroid-free clinical and biological remission by week 52 with treatment optimization.
2. The proportion of patients that maintain steroid-free clinical and biological remission by week 52 (with or without treatment optimization).
3. The proportion of patients that maintain steroid-free clinical and biological remission by week 8, by week 24 (without treatment optimization).
4. The proportion of patients that maintain steroid-free clinical remission by week 8, by week 24, by week 52 (without treatment optimization).
5. The proportion of patients that maintain steroid-free biological remission by week 8, by week 24, by week 52 (without treatment optimization).
6. The proportion of patients switching back to IV infliximab by week 8, by week 24, by week 52.
7. Time to (objectified) clinical relapse (or treatment optimization or treatment discontinuation).
8. Time to objectified clinical relapse (or treatment optimization or treatment discontinuation).
9. Time to treatment optimization (or treatment discontinuation).
10. Time to treatment discontinuation.
11. Time to clinical relapse (patients that undergo treatment optimization or treatment discontinuation without clinical relapse will be regarded as lost to follow-up from that timepoint).
12. Time to objective clinical relapse (patients that undergo treatment optimization or treatment discontinuation without objective clinical relapse will be regarded as lost to follow-up from that timepoint).
13. Patients experience and satisfaction with switching to SC therapy by week 8, week 24, by week 52.
14. The proportion of eligible patients willing to switch and effectively switching to SC therapy.
15. Baseline characteristics linked to willingness of switching and effectively switching to SC therapy.
16. Reasons for willing or not willing to switch to SC therapy.
17. Reasons for treatment optimization (clinical disease activity, biological disease activity, endoscopic disease activity, radiological disease activity, and/or other).
18. Reasons for treatment discontinuation (clinical disease activity, biological disease activity, endoscopic disease activity, radiological disease activity, adverse events, pregnancy, patient's request, and/or other).
19. The number and type of (serious) adverse events by week 52.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Belgian IBD Research and Development

Sponsor organisation

Belgian IBD Research and Development

Address

Leuvensesteenweg 643

City

Zaventem

Postcode

1930

Country

Belgium

Scientific contact point

Organisation

Belgian IBD Research and Development

Contact name

Tom Holvoet

Public contact point

Organisation

Belgian IBD Research and Development

Contact name

Ingrid Arijs

Locations

1 EU/EEA country · 21 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 56 files

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

Application history

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