An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01644396
Phase
PHASE4
Status
Completed

Conditions

  • Moderate to Severe Plaque Psoriasis

Eligibility Criteria

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

Interventions

Study Details

This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.

Key Dates

Start date
May 31, 2012
Status verified
Sep 2014
Primary completion
Sep 30, 2013
Completion
Sep 30, 2013

Study Design

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

Arms

  • Other: Adalimumab
    Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.

Primary Outcome Measure

Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 [ Time Frame: Baseline and Week 24 ]

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