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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT01183403
Eligibility Criteria:
Inclusion Criteria:
* Crohn's disease defined according to the usual endoscopic, histological, and radiological criteria
* Small bowel (jejunum or ileum) stricture identified by radiography or endoscopy
* Obstructive symptoms greater than or equal to 3 on a scale from 0 to 6 evaluated over the last 8 weeks
* Failure of corticosteroids and/or immunosuppressives and indication for anti-TNF therapy
Exclusion Criteria:
* Nonresolving complete bowel obstruction
* Previous anti-TNF therapy
* Contraindication to anti-TNF therapy:
* Intra-abdominal, intra-mural or extramural abscess
* Active infection
* Severe infection during the previous 2 months
* Nontreated latent tuberculosis
* Heart failure
* Active malignancy during the previous 5 years
* Demyelinating neurological disease
* Modification of the treatment of Crohn's disease during the previous two months: azathioprine, mercaptopurine, methotrexate, thalidomide
* Contraindication to MR enterography or contrast-enhanced ultrasonography
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01183403
Study Brief:
Protocol Section:
NCT01183403