Status:
RECRUITING
InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Celltrion
Conditions:
Inflammatory Disease
Disease Crohn
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Study Design: A Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators dur...
Detailed Description
Permitted concomitant medications: Oral prednisone (≤40 mg per day) or budesonide (≤9 mg per day) are permitted if on stable dose 2 weeks prior to screening. After 2 weeks into treatment, systemic co...
Eligibility Criteria
Inclusion
- Patients 18 years or older diagnosed with Crohn's disease
- Patients with moderate to severely active Crohn's disease with a Crohn's Disease Activity Index (CDAI) of 250 to 450 and presence of endoscopic ulceration in the terminal ileum, colon or both. Minimal SES-CD is ≥ 6 or ≥ 4 for isolated ileal disease.
- Patients who had no response or loss of response to or have had intolerable side effects to one or more to the following: glucocorticoids, thiopurines (azathioprine/6-mercaptopurine/6-thioguanin), methotrexate , adalimumab, vedolizumab or ustekinumab OR patients in need of immediate top-down treatment with IFX at the discretion of the treating physician.
- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
- The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedure.
- Male or non-pregnant, non-lactating females. No wish to become pregnant in the coming 26 weeks.
Exclusion
- Patients at imminent need of surgery as judged by the treating clinician
- Patients with the short bowel syndrome, an ostomy or a symptomatic non-inflammatory stricture
- Patients previously exposed to IFX (intravenous or subcutaneous)
- Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate)
- Treatment with adalimumab or vedolizumab or ustekinumab within 30 days
- Patients who have had a primary non-response to adalimumab or had intolerable class-related side effects (as evaluated at the discretion of the treating physician)
- Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening
- Ongoing participation in another interventional trial
- Patients with Ulcerative Colitis or Inflammatory bowel disease unclassified (IBD-U)
- Patients with ongoing abdominal or undrained perianal abscess
- Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed
- Active or latent tuberculosis (screening according to national guidelines). Except when the latter has been treated appropriately according to national guidelines.
- Cardiac failure in the New York heart Association (NYHA) stage III-IV
- History of demyelinating disease
- Recent live vaccination (≤ 4 weeks)
- Patients with ongoing acute/chronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical human papillomavirus (HPV)
- History of cancer in the last 5 years with the exception of non-melanoma skin cancer
- Male patients with Epstein-Barr virus (EBV) negative serology
- A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures
- Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures
- Patients unable to attend all study visits
- Patients with a history of non-compliance with clinical study protocols
- Contraindication for endoscopy
- Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer
- Pregnancy or lactation or wish to become pregnant in the coming 26 weeks
Key Trial Info
Start Date :
November 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT06059989
Start Date
November 25 2021
End Date
December 1 2025
Last Update
December 10 2024
Active Locations (1)
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1
Amsterdam UMC AMC
Amsterdam, North Holland, Netherlands, 1105AZ