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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Biological: adalimumab; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02499783

M14-233

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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205 participants in 2 patient groups

Placebo Induction Regimen

Experimental group

Description:

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.

Treatment:

Other: placebo

Biological: adalimumab

Adalimumab Induction Regimen

Experimental group

Description:

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.

Treatment:

Biological: adalimumab