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OpenTrials
Completed

NCT Number: NCT03923738

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

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).

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Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitätsspital Basel; Rheumatologie, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tocilizumab

Drug

TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.

Other names: RoActemra/Actemra

Primary outcomes

  1. Maximum Serum Concentration (Cmax) of TCZ

    Time frame: Baseline; Weeks 4, 8, 12, 16-24

  2. Trough Serum Concentration (Ctrough) of TCZ at Steady State

    Time frame: Baseline; Weeks 4, 8, 12, 16-24

  3. Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State

    Time frame: Baseline; Weeks 4, 8, 12, 16-24

  4. Percentage of Participants With Adverse Events

    Time frame: Baseline - Day 151

Secondary outcomes

  1. Serum Concentration of Interleukin-6 (IL-6)

    Time frame: Baseline; Weeks 12, 16, 20, 24

  2. Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)

    Time frame: Baseline; Weeks 12, 16, 20, 24

  3. Serum Concentration of C-Reactive Protein (CRP)

    Time frame: Baseline; Weeks 4, 8, 12, 16-24

  4. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline; Weeks 4, 8, 12, 16-24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 23, 2019
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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