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New treatment option for Inflammatory Disease
Official title InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease
ClinicalTrials.gov ID: NCT06059989
What this study is testing
What is Infliximab subcutaneous?
Infliximab subcutaneous is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for inflammatory disease.
Also referred to as Remsima 120mg solution s.c..
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 during Induction treatment in Moderate to Severe Crohn's Disease. Primary endpoint: The proportion of patients in corticosteroid-free clinical remission (as defined by a Crohn's disease activity index (CDAI)\<150) and endoscopic response (as defined by a simple endoscopic score for Crohn's disease (SES-CD) drop of at least 50%) at week 26.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Patients who had no response or loss of response to or have had intolerable side effects to one or more to the following: glucocorticoids...
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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 ≥...
- 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...
- 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.
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.