Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity

Sponsor
Reade Rheumatology Research Institute
Study ID
NCT04222920
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dose reduction to 2mg/L — OTHER
    Adalimumab dose reduction aiming drug concentration of 2mg/L
  • Dose reduction to 5mg/L — OTHER
    Adalimumab dose reduction aiming drug concentration of 5mg/L
  • Adalimumab — DRUG
    Adalimumab

Study Details

Several prior studies have shown that dose reduction or discontinuation of tumor necrosis factor (TNF)-inhibitors, like adalimumab, is possible in substantial number of patients with a rheumatic disease without an increase in disease activity. Prior studies showed that patients with concentrations higher than 5 mg/L are overexposed to adalimumab and can safely reduce the dose. In the first phase of treatment, an adalimumab concentration of 5mg/L is needed to achieve adequate clinical response. However to control disease activity after 28 weeks, lower concentration than 5 mg/L are probably sufficient. Recent published data suggest that concentrations of 0.1-0.5 mg/L are enough to control TNF blockade in this state. Yet, a study which investigates the lowest effective drug serum concentration is missing so far. The hypothesis is that serum adalimumab concentration of 2 mg/L is sufficient to control disease activity.

Key Dates

Start date
Mar 1, 2020
Status verified
Nov 2023
Primary completion
Sep 11, 2023
Completion
Sep 11, 2023

Study Design

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

Arms

  • Experimental: Low serum drug concentration
    Adalimumab dose reduction aiming a drug level of 2 mg/L
  • Active Comparator: High serum drug concentration
    Adalimumab dose reduction aiming a drug level of 5 mg/L

Primary Outcome Measure

Mean time weighted DAS28-CRP [ Time Frame: after 24 weeks ]

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