Back to resultsA Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
Primary Purpose
Giant Cell Arteritis
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
About this trial
This is an interventional treatment trial for Giant Cell Arteritis
Eligibility Criteria
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.
Sites / Locations
- Universitätsspital Basel; Rheumatologie
- Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TCZ IV Q4W
Arm Description
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.
Outcomes
Primary Outcome Measures
Maximum Serum Concentration (Cmax) of TCZ
Trough Serum Concentration (Ctrough) of TCZ at Steady State
Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State
Percentage of Participants With Adverse Events
Secondary Outcome Measures
Serum Concentration of Interleukin-6 (IL-6)
Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)
Serum Concentration of C-Reactive Protein (CRP)
Erythrocyte Sedimentation Rate (ESR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03923738
Brief Title
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
November 12, 2020 (Actual)
Study Completion Date
November 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TCZ IV Q4W
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
RoActemra/Actemra
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Serum Concentration (Cmax) of TCZ
Time Frame
Baseline; Weeks 4, 8, 12, 16-24
Title
Trough Serum Concentration (Ctrough) of TCZ at Steady State
Time Frame
Baseline; Weeks 4, 8, 12, 16-24
Title
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
Title
Percentage of Participants With Adverse Events
Time Frame
Baseline - Day 151
Secondary Outcome Measure Information:
Title
Serum Concentration of Interleukin-6 (IL-6)
Time Frame
Baseline; Weeks 12, 16, 20, 24
Title
Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)
Time Frame
Baseline; Weeks 12, 16, 20, 24
Title
Serum Concentration of C-Reactive Protein (CRP)
Time Frame
Baseline; Weeks 4, 8, 12, 16-24
Title
Erythrocyte Sedimentation Rate (ESR)
Time Frame
Baseline; Weeks 4, 8, 12, 16-24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsspital Basel; Rheumatologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Citations:
PubMed Identifier
35659282
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
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