E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038283 |
E.1.2 | Term | Regional enteritis of small intestine with large intestine |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of effects on angiogenesis by adalimumab after 12 weeks of therapy |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 . |
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E.4 | Principal 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; |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of effects on angiogenesis by adalimumab after 12 weeks of therapy |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
verificare effetto delAdalimumab sul VEGF |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 13 |