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:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT02048618
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects between 18 and 75 years
* Documented history of ileal, colonic, or ileocolonic CD
* CDAI score ≥ 220 to ≤ 450
* Evidence of active inflammation as demonstrated by endoscopic confirmation of active disease
* Subjects previously not exposed to anti-TNF treatment (TNF-naïve) or subjects previously exposed to anti-TNF therapy at a registered dose, that has been discontinued at least 8 weeks prior to Screening and deemed by the treating physician as a primary or secondary non-responder or intolerant (TNF-experienced)
* Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), mesalazine, olsalazine, CD-related antibiotics and probiotics at stable dose is allowed
* Previous exposure to immunomodulators is permitted, but must be discontinued
* Haematology and biochemistry lab parameters within predefined ranges as stated in the protocol
Exclusion Criteria:
* Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC
* Stoma, gastric or ileoanal pouch, procto- or total colectomy, symptomatic stenosis or obstructive strictures, history of bowel perforation, (suspected) abscess; actively draining fistulae
* Subject who has had surgical bowel resections within the past 6 months, short bowel syndrome or is receiving tube feeding, defined formula diets, or parenteral alimentation
* Subject with positive Clostridium difficile toxin stool assay or evidence of any other gastrointestinal infection
* Subject who has received non-permitted IBD therapies within specified timeframes, depending on the medication, as stated in the protocol
* Subject with a (previous history of) dysplasia of the gastrointestinal tract
* Concurrent gastro-intestinal malignancy or a history of cancer elsewhere
* History of lymphoproliferative disease
* Known active infection of any kind, current therapy for chronic infection or history of specific infections as stated in the protocol
* Subject who is pregnant, lactating or not willing to maintain highly effective birth control methods during the course of the study and 12 weeks thereafter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02048618
Study Brief:
Protocol Section:
NCT02048618