A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease

Sponsor
AbbVie
Study ID
NCT01958827
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab pre-filled syringe, administered by subcutaneous injection.

Study Details

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.

Key Dates

Start date
Sep 30, 2013
Status verified
Mar 2016
Primary completion
Mar 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab 80 mg
    All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.

Primary Outcome Measure

Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8 [ Time Frame: Week 8 ]

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