Methods |
Randomised, placebo‐controlled, double‐blind trial date: January 2014 to April 2016 Location: worldwide |
Participants |
Total sample size: 217 Inclusion criteria
Adults with clinical diagnosis of chronic plaque psoriasis (with a disease duration of ≥ 6 months) and ≥ 1 fingernail with nail psoriasis
BSA ≥ 10% and a target fingernail mNAPSI ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail Nail Psoriasis Severity index (NAPSI) ≥ 8 and a total mNAPSI score of ≥ 20 at Week 0
Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain score of > 3
PGA of fingernail psoriasis and a PGA of skin psoriasis of ≥ moderate
Must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for ≥ 4 weeks prior to Week 0, ustekinumab must have been discontinued ≥ 12 weeks prior to Week 0
Target fingernail must have mNAPSI score of ≥ 8
Exclusion Criteria
Prior adalimumab therapy
Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis
Recent infection requiring treatment
Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse
Women who are pregnant or breast‐feeding or considering becoming pregnant during the study
History of cancer, except successfully treated skin cancer
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Interventions |
Intervention Adalimumab, SC, 40 mg, eow for 25 weeks starting 1 week after initial loading dose of 80 mg Control intervention Placebo |
Outcomes |
At week 12 mNAPSI 75, PGA of fingernails of clear or minimal PASI 75/90/100 for participants with baseline PASI at 5 |
Notes |
NCT02016482
Abstract
No original paper published. We emailed the study authors (3 and 12 January 2017) for the protocol and results. Abbvie response: "As this data has not been published in a manuscript at this time I am providing the link below for you to submit a request for this data. Please let me know if you have any further questions". Will be included when published |