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 | 10011401 |
E.1.2 | Term | Crohn's disease |
|
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 |
To demonstrate the efficacy of adalimumab on mucosal healing in subjects with moderate to severe ileocolonic Crohn s disease. |
|
E.2.2 | Secondary objectives of the trial |
To delineate the safety of adalimumab when administered to subjects with Crohn s disease. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Diagnosis of Crohn s Disease for greater than 4 months. 2.A diagnosis of ileocolonic Crohn s Disease confirmed by endoscopy or radiologic evaluation within 3 years of Baseline. 3.For subjects that have had operations in the ileocolonic region of the intestine after documented diagnosis of ileocolonic disease, postoperative recurrence of the disease must be documented. 4. Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3 on the Ulcerated Surface subscore of the SES-CD. 5.Crohn s Disease Activity Index CDAI score of 220 and 450. 6.Males and females 18 and 75 years of age at the Baseline visit. 7.Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication. 8.Subjects must agree to undergo up to 4 endoscopies. |
|
E.4 | Principal exclusion criteria |
1.History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneos squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix. 2.History of listeria, human immunodeficiency virus HIV , Hepatitis B, an immunodeficiency syndrome, central nervous system CNS demyelinating disease or untreated TB. 3.Subjects with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the investigator and Abbott Medical Monitor. 4.Subjects 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.Subjects with an ostomy or ileoanal pouch. Subjects with a previous ileo-rectal anastomosis are not excluded . 6.Subjects who has previously used infliximab or any anti-TNF agent and has not clinically responded. 7.Previous treatment with adalimumab or previous participation in an adalimumab clinical study. 8.Subjects on prednisone 40 mg/day or equivalent . 9.Subjects on budesonide 9 mg/day. 10.Subjects with any prior exposure to Tysabri natalizumab . |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the presence or absence of mucosal ulceration by endoscopy. The primary outcome analysis will be a comparison of the proportions of subjects without mucosal ulceration on endoscopy in the adalimumab and placebo groups at Week 12. |
|
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 |
|
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
| |
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 | 8 |
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 | 9 |