E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 in the treatment of subjects with Crohn's disease who either initially responded to administration of infliximab but stopped responding or were intolerant to infliximab; to delineate the safety of adalimumab when administered to subjects with Crohn's disease; to assess the pharmacokinetics (PK) of adalimumab following subcutaneous administration. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. A diagnosis of Crohn's disease confirmed by endoscopy or radiologic evaluation. 2. Crohn's Disease Activity Index (CDAI) score of ³220 and £450. 3. Males and females ³18 and £75 years of age at the screening visit. 4. If female, subject is either not of child bearing potential, defined as post menopausal for at least (1) year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control during the study and for 150 days after the last dose: ● Condoms, sponge, foam, jellies, diaphragm or intrauterine device ● Oral or parenteral contraceptives for three months prior to study drug administration ● A vasectomized partner 5. If female, subject is not breast-feeding throughout the study and for 150 days after the last dose. 6. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol. 7. Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits. 8. Subjects must have previously been administered infliximab and discontinued use due to a loss of response or intolerance to infliximab therapy. (See Appendix A for definitions).
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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-in-situ of the cervix. 2. History of listeria, human immunodeficiency virus (HIV), an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or untreated TB. 3. Subject with ulcerative colitis. 4. Subject with symptomatic known obstructive strictures. 5. 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. 6. Subject with an ostomy or ileoanal pouch. 7. Subject who has short bowel syndrome as determine by the investigator. 8. Subject who is currently receiving total parenteral nutrition (TPN). 9. Females who are pregnant or breast-feeding. 10. Subject who has received any investigational chemical agent in the past 30 days or 5 half-lives prior to Screening (whichever is longer). 11. Subject who has received any investigational biological agent in the past 3 months or 5 half-lives prior to Screening (whichever is longer). 12. Subject who has had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to Screening for all non-Crohn's related infections. 13. Subject with a history of clinically significant drug or alcohol abuse in the last year.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable will be the induction of clinical remission, which is defined as a CDAI score of <150 at week 4. |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
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 | No |
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 | Yes |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
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 | 11 |