This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.
Universitätsspital Basel; Rheumatologie
Basel, Switzerland
Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie
Bern, Switzerland
Maximum Serum Concentration (Cmax) of TCZ
Time frame: Baseline; Weeks 4, 8, 12, 16-24
Trough Serum Concentration (Ctrough) of TCZ at Steady State
Time frame: Baseline; Weeks 4, 8, 12, 16-24
Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State
Time frame: Baseline; Weeks 4, 8, 12, 16-24
Percentage of Participants With Adverse Events
Time frame: Baseline - Day 151
Serum Concentration of Interleukin-6 (IL-6)
Time frame: Baseline; Weeks 12, 16, 20, 24
Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)
Time frame: Baseline; Weeks 12, 16, 20, 24
Serum Concentration of C-Reactive Protein (CRP)
Time frame: Baseline; Weeks 4, 8, 12, 16-24
Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline; Weeks 4, 8, 12, 16-24
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