Medical research to compare the effectiveness of infliximab injections alone or in combination with immunosuppressive drugs in the treatment of Crohn's disease.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

completed 20 Nov 2025

Decision date (initial)

2024-09-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Celltrion

External identifiers

EU CT number

2024-517171-20-00

EudraCT number

2021-000469-33

ClinicalTrials.gov

NCT06059989

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective this study is to investigate the efficacy of subcutaneous IFX in the treatment of moderate to severe Crohn’s disease with and without concomitant immunosuppression, as measured by the proportion of patients in corticosteroid-free clinical remisison (as defined by a CDAI<150) and endoscopic response (as defined by a SES-CD drop of at least 50%) at week 26. We hypothesize that subcutaneous IFX monotherapy is non-inferior to subcutaneous IFX with concomitant immunosuppression in inducing this combined primary endpoint of CSF clinical remission and endoscopic response by week 26.

Secondary objectives 1

1. Secondary objectives are to investigate the safety as well as the efficacy of subcutaneous IFX monotherapy as compared to IFX therapy combined with immunosuppressives during 26 weeks of treatment, as evaluated by clinical scores, patient reported outcomes, quality of life measures, biomarkers and endoscopy. IFX trough concentration and proportion of anti-drug antibody development will be evaluated and correlated with HLA-haplotypes.

Conditions and MedDRA coding

Crohn's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Patients 18 years or older who have been diagnosed with Crohn’s disease. 2. Patients with moderate to severely active Crohn’s disease with a Crohn’s Disease Activity Index (CDAI) of 220 to 450 and exhibiting objective evidence of inflammation, defined as endoscopic ulceration in the terminal ileum, colon or both with a minimal SES-CD is ≥ 6 (in colonic or ileocolonic disease) or ≥ 4 for isolated ileal disease. 3. Patients who had no response to, or had unacceptable side effects to one or more to the following: glucocorticoids or thiopurines (azathioprine/6-mercaptopurin/6-thioguanin) or methotrexate or adalimumab OR patients on the discretion of the treating physician immediately qualify for top-down treatment with IFX. 4. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. 5. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 6. Male or non-pregnant, non-lactating females. No wish to become pregnant in the coming 26 weeks

Exclusion criteria 1

1. 1. Patients at imminent need of surgery as judged by the treating clinician. 2. Patients with the short bowel syndrome, an ostomy or a symptomatic stricture. 3. Patients previously exposed to IFX. 4. Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate). 5. Treatment with adalimumab within 15 days and vedolizumab and ustekinumab within 30 days. 6. Patients who had had a primary non-response to adalimumab or had intolerable class-related side effects. 7. Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening. 8. Active participation in another interventional trial. 9. Patients with Ulcerative Colitis or IBD-UC. 10. Patients with ongoing abdominal or undrained perianal abscess. 11. Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed. 12. Active or latent tuberculosis (screening according to national guidelines). 13. Cardiac failure in NYHA stage III-IV. 14. History of demyelinating disease. 15. Recent live vaccination (≤ 4 weeks).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of patients in corticosteroid-free clinical remission (as defined by CDAI<150) AND endoscopic response (a drop of at least 50% in SES-CD compared to baseline) at week 26

Secondary endpoints 1

1. The proportion of patients in endoscopic remission at week 26 (defined as the absence of ulcerations larger then 5mm)  Proportion of patients with endoscopic remission at week 26 (as measured by SES-CD≤2)  Proportion of patients with endoscopic response at week 26 (as measured by at least 50% reduction in the SES-CD as compared to baseline)  Proportion of patients in corticosteroid-free clinical remission at week 26 (defined as a CDAI<150)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Dr. K. Gecse

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Dr. K. Gecse

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Results and documents

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

Documents 4 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