E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis (UC) is a type of inflammatory bowel disease where inflammation develops in the large intestine (colon) and rectum. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009900 |
E.1.2 | Term | Colitis ulcerative |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 |
The primary objective is 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 or Study M06-827. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess pharmacokinetics of adalimumab following
subcutaneous administration. |
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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. Subject is judged to be in generally good health as determined by the principal investigator. |
|
E.4 | Principal exclusion criteria |
1. Subject has not responded to weekly adalimumab therapy in M06-826 or M06-827
2. Subject considered by the investigator, for any reason, to be an unsuitable candidate
3. Female subject who is pregnant or breast-feeding or considering becoming pregnant |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline in Mayo Scores and Partial Mayo Scores at the following time frames: Week 48, Week 96, Week 144, Week 192, Week 240 , Week 292, Week 304 and Week 388 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 48, Week 96, Week 144, Week 192, Week 240, Week 292, Week 304 and Week 388 |
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E.5.2 | Secondary end point(s) |
Change from Baseline in IBDQ & SF-36; Work Productivity and Activity
Impairment Questionnaire at the following time frames: Week 48, Week
96, Week 144, Week 192, Week 240 and Week 292; AEs, Laboratory data, physical
exams, and vital signs throughout course of the study |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 48, Week 96, Week 144, Week 192, Week 240 and Week 292; AEs, Laboratory
data, physical exams, and vital signs throughout course of the study |
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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 | Yes |
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 | 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) | 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.8.5.1 | Number of sites anticipated in the EEA | 62 |
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 | No |
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 |
Australia |
Austria |
Belgium |
Canada |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Israel |
Italy |
Netherlands |
New Zealand |
Norway |
Poland |
Portugal |
Puerto Rico |
Slovakia |
Sweden |
Switzerland |
|
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
|
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. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |