A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
- Autoimmune Disorder
- Giant Cell Arteritis
NCT03923738 2018-004718-17 WP41152
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., 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.
For the latest version of this information please go to www.forpatients.roche.com