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

Giant Cell Arteritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923738
• Other study ID #: WP41152
• Secondary ID: 2018-004718-17
• Status: Completed
• Phase: Phase 1
• Start date: August 5, 2019
• Est. completion date: November 12, 2020

Study information

• Verified date: November 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 12, 2020
• Est. primary completion date: November 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• Tocilizumab
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.

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel; Rheumatologie	Basel
Switzerland	Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Serum Concentration (Cmax) of TCZ		Baseline; Weeks 4, 8, 12, 16-24
Primary	Trough Serum Concentration (Ctrough) of TCZ at Steady State		Baseline; Weeks 4, 8, 12, 16-24
Primary	Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State		Baseline; Weeks 4, 8, 12, 16-24
Primary	Percentage of Participants With Adverse Events		Baseline - Day 151
Secondary	Serum Concentration of Interleukin-6 (IL-6)		Baseline; Weeks 12, 16, 20, 24
Secondary	Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)		Baseline; Weeks 12, 16, 20, 24
Secondary	Serum Concentration of C-Reactive Protein (CRP)		Baseline; Weeks 4, 8, 12, 16-24
Secondary	Erythrocyte Sedimentation Rate (ESR)		Baseline; Weeks 4, 8, 12, 16-24