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Completed

NCT Number: NCT00445939

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Biological

160 mg at Week 0, 80 mg at Week 2

Other names: ABT-D2E7, Humira

Placebo

Biological

Placebo at Week 0 and Week 2

Primary outcomes

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

    Time frame: 4 Weeks

    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.

Secondary outcomes

  1. Clinical Remission (CDAI < 150) at Week 2

    Time frame: 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.

  2. Clinical Response (CR-70 and CR-100) in Period A

    Time frame: Weeks 2 and Week 4

    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.

  3. Clinical Response (CR-70 and CR-100) in Period B

    Time frame: Week 6 and Week 8

    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.

  4. Clinical Remission (CDAI <150) at Week 6 and Week 8

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Abbott Japan Co.,Ltd
  • Eisai Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
First posted
Mar 9, 2007
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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