Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT03629379
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ustekinumab — DRUG
    Patients will receive standard dosing of ustekinumab with a single intravenous infusion of about 6mg/kg ustekinumab at week 0, followed by ustekinumab 90mg subcutaneously every 8 weeks.
  • Vedolizumab — DRUG
    Patients will receive standard dosing of vedolizumab 300mg at weeks 0, 2, 6, and 14. Patients with Crohn's disease could receive an extra infusion at week 10.

Study Details

Using transcriptomics and proteomics to gain insights in the development of psoriasiform skin lesions under anti-tumor necrosis factor (TNF) therapy, and predicting response to ustekinumab.

Key Dates

Start date
Jan 22, 2019
Status verified
Apr 2018
Primary completion
Jan 1, 2021
Completion
Jul 1, 2021

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: ustekinumab arm
    First 10 patients who are switched from anti-TNF to ustekinumab because of psoriasiform skin lesions refractory to 12 weeks of topical therapy.
  • Active Comparator: vedolizumab arm
    First 10 patients who are switched from anti-TNF to vedolizumab because of psoriasiform skin lesions refractory to 12 weeks of topical therapy.

Primary Outcome Measure

Transcriptomic features [ Time Frame: 3 years ]

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