Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-17

Study Completion Date

2017-12-15

Brief Summary

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This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Induction Regimen

Double-blind period (Weeks 0-8): Placebo at Weeks 0 and 2, followed by adalimumab 160 mg at Week 4, 80 mg at Week 6.

Open label period: adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

subcutaneous injections of adalimumab

placebo

Intervention Type OTHER

subcutaneous injections of placebo

Adalimumab Induction Regimen

Double-blind period (Weeks 0-8): adalimumab 160 mg at Weeks 0 and 80 mg at Week 2, followed by adalimumab 40 mg at Week 4 and Week 6.

Open label period: adalimumab 40 mg eow from Week 8 through last dose at Week 24.

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

subcutaneous injections of adalimumab

Interventions

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adalimumab

subcutaneous injections of adalimumab

Intervention Type BIOLOGICAL

placebo

subcutaneous injections of placebo

Intervention Type OTHER

Other Intervention Names

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Humira

Eligibility Criteria

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Inclusion Criteria

* Subjects of Chinese descent with full Chinese parentage.
* Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.
* Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.
* Subject has a negative Tuberculosis (TB) Screening Assessment.
* Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.

Exclusion Criteria

* Subject with ulcerative colitis or indeterminate colitis.
* Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.
* Subject with an ostomy or ileoanal pouch.
* Subject who has short bowel syndrome.
* Subject with symptomatic known obstructive strictures.
* Subject with an internal or external fistula (with the exception of an anal fistula without abscess).
* Active, or chronic or recurring infections, or active tuberculosis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No