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 |
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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 | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
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 |
To demonstrate the long-term safety and efficacy of adalimumab in the maintenance of
clinical remission in Japanese subjects with moderate to severe Crohn's disease who participated in clinical Study M04-729. |
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E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetics of adalimumab and the development of antibodies against adalimumab following sc injections of adalimumab. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A subject will be eligible for study participation if he/she meets the following criteria:
1. Subjects who successfully enrolled in and completed Study M04-729.
2. Subject who can continuously receive isoniazide (INH) for the prophylaxis of latent TB infection if they are receiving INH in Study M04-729 (INH must be administered for 9 months from starting administration of the drug).
3. 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 contraceptives for three months prior to study drug administration
- A vasectomized partner
4. If female of child bearing potential, the result of a urine pregnancy test performed at the screening and Week 0 visit are negative.
5. Subject must be able and willing to give written informed consent and to comply with the
requirements of this study protocol. For the subjects < 20 years old, the subject's parent or legal guardian must be willing to give written informed consent. |
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E.4 | Principal exclusion criteria |
Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 52 of double-blind treatment |
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E.5.2 | Secondary end point(s) |
- Number of Participants Who Had Clinical Response-70 (a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study Baseline Score)
- Number of Participants Who Had Clinical Response-100
- Change in Crohn's Disease Activity Index From Baseline of Lead-in Study
- Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- at Week 52 of Double-blind Treatment
- at Week 52 of Double-blind Treatment
- Week 52 of double-blind treatment
- Week 52 of Open-label Treatment |
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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 | 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) | Yes |
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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |