THE ANTI-ANGIOGENIC EFFECTS OF ADALIMUMAB INCROHN`S DISEASE - ND

• Conditions: Crohn`s Disease; MedDRA version: 9.1Level: LLTClassification code 10038283Term: Regional enteritis of small intestine with large intestine

• Registration Number: EUCTR2009-011763-37-IT
• Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

A subject will be eligible for study participation if he/she meets the following criteria:
1. Diagnosis of moderate to severe Crohn`s Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months
(16 weeks).
2. According to Italian summary of product characteristics .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject will be excluded from the study if he/she meets any of the following criteria:
A subject will be excluded from the study if he/she meets any of the following criteria:
1. History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal
cell carcinoma or carcinoma − in-situ of the cervix.
2. History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central
nervous system (CNS) demyelinating disease or active TB.
3. Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the investigator
4. Subject with symptomatic known obstructive strictures.
5. Subjects with abscess or suspicion of abscess, defined as fever and/or anal pain.
6. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled
in the study.
7. Subject with an ostomy or ileoanal pouch.
8. Subject who has short bowel syndrome as determined by the investigator.
9. Subject who is currently receiving total parenteral nutrition (TPN).
10. Females who are pregnant or will not discontinue breast-feeding.
11. Subject who has received any investigational chemical agent in the past 30 days or 5 half-lives prior to Baseline (whichever is
longer).
12. Subject who has received any investigational biological agent within 5 half-lives prior to Baseline.
13. Subject who has an active infection or has had systemic antibiotic, antiviral, or antifungal treatment within 3 weeks prior to Baseline
for infection. Subjects are allowed to be on ciprofloxacin or metronidazole for their non-infectious Crohn`s symptoms.
14. Subject with a history of clinically significant drug or alcohol abuse in the last year.
15. Subjects with a poorly controlled medical condition such as: uncontrolled diabetes with documented history of recurrent infections,
unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the
opinion of the investigator or the sponsor, would put the subject at risk by participation in the protocol.
16. Subjects with positive C. difficile stool assay.
17. Subject who has previously used infliximab or any anti-TNF within 8 weeks of Baseline.
18. Previous treatment with adalimumab or previous participation in an adalimumab clinical study.
19. Screening laboratory and other analyses show any of the following abnormal results:
● Electrocardiogram (ECG) - with clinically significant abnormalities;
● Aspartate transaminase (AST) or alanine transaminase (ALT) >1.75 x the upper limit of the reference range;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of effects on angiogenesis by adalimumab after 12 weeks of therapy;Secondary Objective: ;Primary end point(s): Evaluation of effects on angiogenesis by adalimumab after 12 weeks of therapy