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
- Adalimumab — BIOLOGICAL
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
- First listed
- Jul 19, 2012
- 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: AdalimumabParticipants 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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