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

Phase 1

Completed

• Conditions: Giant Cell Arteritis
• Interventions: Drug: Tocilizumab

• Registration Number: NCT03923738
• Lead Sponsor: Hoffmann-La Roche

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-23
• Study Start: 2019-08-05
• Primary Completion: 2020-11-12
• Study Completion: 2020-11-12
• Status Verified: 2021-11
• Results First Submitted: 2021-11-04
• Results First Submitted QC: 2021-11-04
• Last Update Submitted: 2021-11-04
• Results First Posted: 2021-12-22
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TCZ IV Q4W	Tocilizumab	Participants will receive up to 6 doses of Dose 1 of TCZ IV Q4W followed by up to 6 doses of Dose 2 of TCZ IV Q4W.

Primary Outcome Measures

Name	Time	Method
Trough Serum Concentration (Ctrough) of TCZ at Steady State	Baseline; Weeks 4, 8, 12, 16-24
Percentage of Participants With Adverse Events	Baseline - Day 151
Maximum Serum Concentration (Cmax) of TCZ	Baseline; Weeks 4, 8, 12, 16-24
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

Secondary Outcome Measures

Name	Time	Method
Serum Concentration of Interleukin-6 (IL-6)	Baseline; Weeks 12, 16, 20, 24
Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)	Baseline; Weeks 12, 16, 20, 24
Serum Concentration of C-Reactive Protein (CRP)	Baseline; Weeks 4, 8, 12, 16-24
Erythrocyte Sedimentation Rate (ESR)	Baseline; Weeks 4, 8, 12, 16-24

Trial Locations

Locations (2)

Universitätsspital Basel; Rheumatologie; 🇨🇭 Basel, Switzerland

Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie; 🇨🇭 Bern, Switzerland