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

NCT ID: NCT03923738

Last Updated: 2021-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2020-11-12

Brief Summary

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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

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Conditions

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Giant Cell Arteritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TCZ IV Q4W

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.

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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RoActemra/Actemra

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Universitätsspital Basel; Rheumatologie

Basel, , Switzerland

Site Status

Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 35659282 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-004718-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP41152

Identifier Type: -

Identifier Source: org_study_id