The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

• Register: EUCTR
• Last refreshed on: 17 November 2014
• Main ID: EUCTR2014-004560-38-Outside-EU/EEA
• Date of registration: 12/11/2014
• Prospective Registration: Yes
• Primary sponsor: Abbott Deutschland GmbH & Co. KG
• Public title: The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
• Scientific title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease.
• Target sample size: 80
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004560-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Japan

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
•Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450.
•If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy.

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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
•Ulcerative colitis or indeterminate colitis
•History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
•Body weight is below 30 kg
•Surgical bowel resections within the past 6 months
•Females who are pregnant or breast-feeding or considering becoming pregnant during the study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Crohn's Disease
MedDRA version: 17.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: 4 weeks

Main Objective: To demonstrate the efficacy and safety of two doses of adalimumab, 160 mg at Week 0 and 80 mg at Week 2 and 80 mg at Week 0 and 40 mg at Week 2 for the induction of clinical remission in Japanese subjects with moderate to severe Crohn's disease and to assess the pharmacokinetics of adalimumab and the development of antibodies against adalimumab following sc injections of adalimumab.

Primary end point(s): The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4.

Secondary Outcome(s)

Secondary end point(s): 1. Proportion of subjects in each treatment group in clinical remission (CDAI < 150) at Week 2, Week 6 and Week 8.
2. Proportion of subjects in each treatment group with a clinical response (CDAI decrease of > 70 compared to Baseline) at Week 2, Week 4, Week 6, and Week 8.
3. Proportion of subjects in each treatment group with a clinical response (CDAI decrease of > 100 compared to Baseline) at Week 2, Week 4, Week 6 and Week 8.
4. Changes from Baseline in CDAI scores in each treatment group at Week 2, Week 4, Week 6, and Week 8.
5. Changes from Baseline in IOIBD scores in each treatment group at Week 2, Week 4, Week 6, and Week 8.
6. Changes from Baseline in IBDQ scores in each treatment group at Week 4, and Week 8.
7. Changes from Baseline in outcomes variables in the SF-36 Health Survey in each treatment group at Week 4, and Week 8.

Timepoint(s) of evaluation of this end point: Multiple timepoints

Secondary ID(s)

NCT00445939

M04-729

Source(s) of Monetary Support

Abbott Japan