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Medical research to compare the effectiveness of infliximab injections alone or in combination with immunosuppressive drugs in the treatment of Crohn's disease.
EU CTIS ID: 2024-517171-20-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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).
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.