Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT02768532
Eligibility Criteria:
Inclusion Criteria :
* Aged over 18 years
* Men or non-pregnant women
* Patients with a diagnosis of Crohn's disease who requires to start Vedolizumab
* Crohn's disease defined as a Crohn's disease Activity Index (CDAI) \> 150 points and/or fecal calprotectin levels \> 250 µg/g of stool
* Crohn's Disease patients with previous failure with TNF (Tumor Necrosis Factor) antagonist agents and unacceptable side-effects from steroids, and/or immunosuppressive agents (i.e., azathioprine, 6-mercaptopurine, or methotrexate). In France, Vedolizumab has to be prescribed only in patients in failure or intolerant to anti-TNF.
* Patient taking corticosteroids orally, concomitant immunosuppressive agents, mesalamine, and antibiotics are allowed at stable dose for at least three months before inclusion. Steroid tapering has to be set up at Week 10 after starting Vedolizumab, according to the European Crohn and Colitis Organisation (ECCO) recommendations with a progressive decrease of steroids of 5 mg/day every week until complete withdrawn.
* Informed written consent given.
Exclusion Criteria:
* Existing pregnancy, lactation, or intended pregnancy within the next 15 months
* Minors or History of disease, including mental/emotional disorder that might interfere with their participation in the study
* Serious secondary illnesses of an acute or chronic nature, which in the opinion of the investigator renders the patient unsuitable for inclusion into the study
* Inability to comply with the protocol requirements
* Inability to fill in the diary cards during the last 7 days before each visit
* Presence of an ileo-/colonic stoma
* Patients with known colonic stricture and exclusive or predominant anal or perineal Crohn's disease lesions
* Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years)
* Short bowel syndrome
* Previous treatments with natalizumab, efalizumab or rituximab.
* Prior extensive colonic resection, obstructive (symptomatic) intestinal stricture, abdominal abscess, active or latent tuberculosis,
* Documented Clostridium difficile superinfection;
* Indeterminate colitis
* Concomitant leukocyte apheresis.
* Any contraindication to vedolizumab therapy
* Patients who denied the protocol, not ability to accept or sign consent of the protocol
* Subject involved in another interventional clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02768532
Study Brief:
Protocol Section:
NCT02768532