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

Sponsor
AbbVie
Study ID
NCT02499783
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    subcutaneous injections of adalimumab
  • placebo — OTHER
    subcutaneous injections of placebo

Study Details

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.

Key Dates

Start date
Aug 17, 2015
Status verified
May 2018
Primary completion
May 19, 2017
Completion
Dec 15, 2017

Study Design

Enrollment
205 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 [ Time Frame: Week 4 ]

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