Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT00573794
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    adalimumab prefilled syringes administered as subcutaneous injection EW or EOW

Study Details

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).

Key Dates

Start date
Nov 28, 2007
Status verified
Jul 2021
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

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

Arms

  • Experimental: Adalimumab 40 mg EOW/EW
    Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.

Primary Outcome Measure

Partial Mayo Score: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]

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