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

  • Giant Cell Arteritis
Trial Status:


This trial runs in
  • Switzerland
Trial Identifier:

NCT03923738 2018-004718-17 WP41152

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      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.

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      Trial Summary

      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).

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03923738 , WP41152 , 2018-004718-17 Trial Identifier
      Tocilizumab Treatments
      Giant Cell Arteritis Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥50 Years Age
      No Healthy Volunteers
      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.

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