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
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • Switzerland
Trial Identifier:

NCT03923738 2018-004718-17 WP41152

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      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.

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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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