Use of Tocilizumab Drug Levels to Optimize Treatment in RA

Sponsor
Reade Rheumatology Research Institute
Study ID
NCT03895879
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Tocilizumab sc (162 mg) once every 2 weeks
  • Tocilizumab — DRUG
    Tocilizumab sc (162 mg) once every week

Study Details

Tocilizumab concentrations above 1 mg/L are likely to be sufficient for normalizing C-reactive protein (CRP) production in patients with rheumatoid arthritis (RA). In practice, however, a large variability in the concentrations of tocilizumab is found, and a large proportion of patients treated with tocilizumab subcutaneously (sc) have concentrations far above 1 mg/L. These patients can probably lower their doses without losing clinical response. A 52 weeks non-inferiority, multicenter, randomized controlled study will be performed to investigate whether patients with RA with serum trough concentrations of tocilizumab higher than 15 mg/L can increase their dosing interval to every two weeks without losing clinical response. Patients with relatively high trough concentrations will be randomly assigned to continuation of the standard dose or to increase dosing interval to every two weeks. The main objective is to investigate the difference in mean time weighted Disease Activity Score in 28 joints, including erythrocyte sedimentation rate (DAS28-ESR) between the two groups after 28 weeks. It is expected that patients with relatively high trough concentrations can safely increase their dosing interval without losing response.

Key Dates

Start date
Mar 1, 2020
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Tocilizumab administered every 2 weeks
  • Active Comparator: Control
    Tocilizumab administered every week
  • Active Comparator: Standard dose (screening < 15 mg/L)
    Tocilizumab administered every week

Primary Outcome Measure

DAS28-ESR [ Time Frame: 28 weeks ]

Central Contacts

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