A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
- Giant Cell Arteritis
NCT03923738 2018-004718-17 WP41152
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
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).
A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis
- Diagnosis of GCA as classified according to protocol-specified criteria;
- Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.
- Treatment with any other investigational agent besides TCZ within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening;
- Evidence of serious uncontrolled disease;
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections;
- Active TB requiring treatment within the previous 3 years.
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