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. 2017 Dec 22;2017(12):CD011535. doi: 10.1002/14651858.CD011535.pub2
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

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
  • Enrollment: 217

  • Study start date: January 2014

  • Study completion date: April 2016


Abstract
  • Journal of the European Academy of Dermatology and Venereology 2016, 30:65


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