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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Biological: adalimumab
* Biological: adalimumab
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab 160 mg/80 mg<br> | Biological: adalimumab<br>* 160 mg at Week 0, 80 mg at Week 2<br>* Other names: Humira;|
| Experimental: Adalimumab 80 mg/40 mg<br> | Biological: adalimumab<br>* 80 mg at Week 0, 40 mg at Week 2<br>* Other names: Humira;|
| Placebo Comparator: Placebo<br> | Biological: placebo<br>* Placebo at Week 0 and Week 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 | CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4. | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission (CDAI < 150) at Week 2 | Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2. | Week 2 | 
| Clinical Response (CR-70 and CR-100) in Period A | The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4. | Weeks 2 and Week 4 | 
| Clinical Response (CR-70 and CR-100) in Period B | The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8. | Week 6 and Week 8 | 
| Clinical Remission (CDAI <150) at Week 6 and Week 8 | The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8 | Week 6 and Week 8 |