Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

Sponsor
AbbVie
Study ID
NCT02015793
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab pre-filled syringe, administered by subcutaneous injection.
  • Placebo for adalimumab — BIOLOGICAL
    Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind.

Study Details

The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.

Key Dates

Start date
Dec 31, 2013
Status verified
Apr 2016
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

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

Arms

  • Experimental: Low Induction Dose
    Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
  • Experimental: Standard Induction Dose
    Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.

Primary Outcome Measure

Mean Serum Adalimumab Concentration at Week 8 [ Time Frame: Week 8 ]

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