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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).

NCT03923738

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Giant Cell Arteritis

Interventions: Tocilizumab

Countries: Switzerland

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).

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (2)

Basel, Switzerland
Bern, Switzerland