A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease.

• Conditions: Crohn's Disease; MedDRA version: 17.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-004531-39-Outside-EU/EEA
• Lead Sponsor: Abbott Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-12
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 80

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified