Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis

Sponsor
Clalit Health Services
Study ID
NCT01494857
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — DRUG
    Adalimumab 40 mg from 4 to 1 injection once in two weeks. Total Treatment period - 10 weeks.

Study Details

The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with biologics.

Key Dates

Start date
Jan 31, 2012
Status verified
Oct 2012
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab
    Adalimumab 40 mg

Primary Outcome Measure

Proportion of subjects with clinical response per Mayo Score, at Week 12 [ Time Frame: week 12 ]

Central Contacts

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