E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
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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 |
Further evaluation and deineation of safety and efficacy profile of Adalimumab in subjects with moderate to savere Crohn Disease |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Diagnosis of moderate to severe Crohn s Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months 16 weeks . 2.Inadequate response to conventional therapy for Crohn s Disease in the opinion of and as documented by the treating physician. 3.Harvey Bradshaw Index score 7. 4.Males and females 18 and 75 years o age at the Baseline visit. 5.Negative pregnancy test 6.Use of reliable contraception 7.Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol 8.Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits. 9.Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication. |
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E.4 | Principal exclusion criteria |
1.History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma 8722; 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.Subjects with abscess or suspicion of abscess. 4.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. 5. Females who are pregnant or will not discontinue breast-feeding. 6.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. 7. Subject with a history of clinically significant drug or alcohol abuse in the last year. 8.Subjects with a poorly controlled medical condition. 9. Subjects with positive C. difficile stool assay. 10.Previous treatment with adalimumab or previous participation in an adalimumab clinical study. 11.Abnormal, clinically significant screening laboratory and other analyses including ECG . 12.Subjects with any prior exposure to Tysabri natalizumab . |
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E.5 End points |
E.5.1 | Primary end point(s) |
Long term safety and efficacy of Adalimumab in subjects with moderate to savere Crohn Disease |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |