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 evaluate the long-term maintenance response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in Protocol M02-404 and Protocol M04-691. |
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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 |
A patient will be eligible for study participation if he/she meets the following criteria: Patients must have successfully enrolled and completed the M02 − 404 or M04-691 study. Female patients: Must continue to utilize a highly effective method of birth control throughout the study and for 70 days after study completion or must not be of childbearing potential, defined as postmenopausal at least two years, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Patients must be able and willing to give written informed consent and to comply with the requirements of this study protocol. 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. |
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E.4 | Principal exclusion criteria |
A subject will be excluded from this study if he/she did not meet all inclusion criteria or met any of the exclusion criteria from the M02-404 study or the M04 − 691 study. In addition a subject will be excluded from this study if he/she does not complete the M02-404 study or the M04-691 study. Female who is pregnant or breast-feeding will be excluded from this study. For any reason, subject is considered by the investigator to be an unsuitable candidate for continuing therapy in the M04-690 study. Subject has abnormal laboratory or other test results that, in the opinion of the investigator, would make it unsuitable for the subject to participate in this study. 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. History of listeria, human immunodeficiency virus (HIV), central nervous system (CNS) demyelinating disease or untreated TB. Subject with ulcerative colitis, symptomatic known obstructive strictures. Subject who has had surgical bowel resections within 6 months prior to the previous study (M02-404 or M04-691) or is planning any resection at any time point while enrolled in the study. Subject with an ostomy or ileoanal pouch. Subject who has short bowel syndrome as determine by the investigator and is currently receiving total parenteral nutrition (TPN). Subject with a history of clinically significant drug or alcohol abuse within one year prior to the previous study (M02-404 or M04-691). Subjects on prednisone > 40 mg/day (or equivalent) or budesonide > 9 mg/day. Subjects currently taking both budesonide and prednisone (or equivalent) are excluded. Subject is not in compliance with prior and concomitant medication requirements 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 sponsor, would put the subject at risk by participation in this study. There were no exclusion criteria for this study since patients participated in the M02-404 and M04-691 studies and were screened against the exclusion criteria of that study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical assessment of CDAI scores and other efficacy measures for maintenance of clinical response and remission during the open-label extension period following year one (1) will be evaluated. Quality of life parameters, including IBDQ, will also be summarized. |
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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 | 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 | 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 | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |