E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis
Colitis Ulcerosa |
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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 | 10009900 |
E.1.2 | Term | Colitis ulcerative |
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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 |
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with ulcerative colitis who participated in and successfully completed Study M06-826 (EudraCT number 2006-002781-20) or Study M06-827 (EudraCT number 2006-002782-40). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject must have successfully enrolled in and completed either the M06-826 study or the M06-827 study. 2. Female must be either not of childbearing potential, defined as postmenopausal for at least 1 year prior to the previous study (M06-826 study or M06-827 study), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following: ● Condoms, sponge, foam, jellies, diaphragm or intrauterine device ● Oral, parenteral or intravaginal contraceptives ● A vasectomized partner 3. Subject has voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC). 4. Subject must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication. 5. Subject is judged to be in generally good health as determined by the principal investigator based upon clinical evaluations performed during the preceding adalimumab ulcerative colitis study (M06-826 study or the M06-827 study).
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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: 1. For any reason, subject is considered by the investigator to be an unsuitable candidate for participation in the M10-223 study. 2. Female who is pregnant will be excluded from this study. 3. Has not responded to weekly adalimumab therapy from Study M06-826 or M06-827. 4. Female subject considering becoming pregnant during the study. There should be at least a 150-day period between the last dose of study drug and conception. 5. History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma and/or localized carcinoma in situ of the cervix. If the Week 52 (Study M06-826 or M06-827) colonoscopy/flexible sigmoidoscopy shows evidence of dysplasia or a malignancy, subject must not be enrolled in the study. 6. History of listeriosis, histoplasmosis, chronic or active hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, central nervous system (CNS) demyelinating disease, or untreated tuberculosis (TB) (active and latent). 7. Currently receiving total parenteral nutrition (TPN). 8. Subject is not in compliance with prior and concomitant medication requirements (Section 5.2.3). 9. Subjects with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe 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. 10. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline. 11. Subjects with known hypersensitivity to the excipients of adalimumab as stated in the label. 12. Current diagnosis of fulminant colitis and/or toxic megacolon. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate long-term maintanence of response, safety and tolerability of repeated administration of adalimumab in subjects with ulcerative colitis. |
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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 | Yes |
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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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 | 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
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This study will conclude approximately 12 weeks after the following criteria have been satisfied: ● Study drug receives country and local (if applicable) regulatory approval for UC. ● All applicable local reimbursement procedures are completed. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |