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

NCT03923738 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: WP411522018-004718-17
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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).

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (4)

• Maximum Serum Concentration (Cmax) of TCZ

  Baseline; Weeks 4, 8, 12, 16-24

• Trough Serum Concentration (Ctrough) of TCZ at Steady State

  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

• Percentage of Participants With Adverse Events

  Baseline - Day 151

Secondary Outcomes (4)

• 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

Study Arms (1)

TCZ IV Q4W

EXPERIMENTAL

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.

Drug: Tocilizumab

Interventions

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.

Also known as: RoActemra/Actemra

TCZ IV Q4W

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Universitätsspital Basel; Rheumatologie

Basel, 4031, Switzerland

Location

Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie

Bern, 3010, Switzerland

Location

Related Publications (1)

• Schmitt C, Brockwell L, Giraudon M, Zucchetto M, Christ L, Bannert B, Daikeler T, Villiger PM. Intravenous tocilizumab for the treatment of giant cell arteritis: a phase Ib dose-ranging pharmacokinetic bridging study. Arthritis Res Ther. 2022 Jun 4;24(1):133. doi: 10.1186/s13075-022-02815-9.

  PMID: 35659282 DERIVED

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 23, 2019
• Study Start: August 5, 2019
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: December 22, 2021
• Results First Posted: December 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

CH (2)