A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated

Sponsor
University Hospital, Ghent
Study ID
NCT05683054
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels — BIOLOGICAL
    In the dose tapering arm, adalimumab dosing frequency will be lowered to 40 mg every 3 weeks in patients who have supratherapeutic serum trough levels of adalimumab (33% reduction). If patients still have a good clinical response and supratherapeutic adalimumab serum trough levels, will be further tapered to a dose regimen of 1 subcutaneous injection (40mg) every 4 weeks (50% dose reduction).
  • Venapuncture — PROCEDURE
    Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab
  • Dermatology Life Quality Index (DLQI) — OTHER
    The impact of the disease on the patient will be assessed using the dermatology life quality index (DLQI).
  • EQ-5D-5L questionnaire — OTHER
    The EQ-5D-5L which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments will be assessed.
  • Dried blood spot sampling — PROCEDURE
    A subset of patients will sample additionally by using dried blood sampling after the first drug injection post-inclusion.

Study Details

Recently, the optimal therapeutic serum trough level range of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab serum through level above this therapeutic range did not add to clinical response. Based on this therapeutic window, the introduction of dose adjustments based on serum trough levels (therapeutic drug monitoring) will be further validated in a prospective controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab STLs, dose reduction based on therapeutic drug monitoring (TDM) is able to maintain the initial clinical outcome.

Key Dates

Start date
Aug 11, 2020
Status verified
Jan 2023
Primary completion
Mar 22, 2022
Completion
Aug 22, 2022

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard dosing group
    In the standard based arm, patients will continue to receive adalimumab according to the standard dosing schedule of 40 mg every other week (maintenance phase).
  • Active Comparator: Dose tapering group
    In the dose tapering arm, adalimumab dosing frequency will be lowered to 40 mg every 3 weeks in patients who have supratherapeutic serum trough levels of adalimumab at three consecutive measurements.

Primary Outcome Measure

Clinical response [ Time Frame: 1 year after inclusion ]

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