Giant Cell ArteritisPhase 1NCT03923738

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

A Phase 1 study testing Tocilizumab in people with Giant Cell Arteritis, run by Hoffmann-La Roche at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Giant Cell Arteritis
What is being tested?: Tocilizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesSwitzerland
Study dates: 5 Aug 2019to 12 Nov 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

Universitätsspital Basel; Rheumatologie
Basel, 4031
Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie
Bern, 3010

Other trials in Switzerland

About this study

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

Conditions: Giant Cell Arteritis
Being tested: Tocilizumab
Medical subject headings: Giant Cell Arteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TocilizumabDrug
Also called RoActemra/Actemra
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.

Study groups in NCT03923738
Study group	Role	What they receive
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. Receives: Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 201912 Nov 2020

First posted23 Apr 2019
Study start5 Aug 2019
Primary completion12 Nov 2020
Study completion12 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03923738
Sponsor's protocol ID: WP41152
Other IDs: 2018-004718-17, 2018
Status last verified: Nov 2021
First submitted: 19 Apr 2019
Last updated: 22 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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).

Publications

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.
PubMed 35659282

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
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Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
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RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis

All Giant Cell Arteritis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03923738
Acronym / sponsor ID: WP41152
Conditions: Giant Cell Arteritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 5 Aug 2019 (actual)
Primary completion: 12 Nov 2020 (actual)
Study completion: 12 Nov 2020 (actual)
First posted: 23 Apr 2019 (actual)
Results: Posted 22 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TCZ IV Q4W	Experimental	Drug: TocilizumabParticipants 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TocilizumabAlso: RoActemra/ActemraTCZ 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.	Drug	TCZ IV Q4W

Primary outcome

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

4 secondary outcomes

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

Results and safety

Results posted to the registry on 22 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TCZ IV Q4W	24	22

Primary outcome: Maximum Serum Concentration (Cmax) of TCZ

Time frame: Baseline; Weeks 4, 8, 12, 16-24. Median (Full Range). Unit: ug/mL

Measure	TCZ IV Q4W 7 mg/kg n = 21	TCZ IV Q4W 6 mg/kg n = 22
Value	197 (118 to 352)	178 (115 to 320)

Population analysed: The pharmacokinetic (PK) population consisted of participants who received one dose of TCZ and had one valid PK sample, with participants grouped according to treatment received.

Primary outcome: Trough Serum Concentration (Ctrough) of TCZ at Steady State

Time frame: Baseline; Weeks 4, 8, 12, 16-24. Median (Full Range). Unit: ug/mL

Measure	TCZ IV Q4W 7 mg/kg n = 22	TCZ IV Q4W 6 mg/kg n = 22
Value	37.2 (6.59 to 69.0)	22.7 (3.38 to 54.5)

Population analysed: The pharmacokinetic (PK) population consisted of participants who received one dose of TCZ and had one valid PK sample, with participants grouped according to treatment received.

Primary outcome: 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. Median (Full Range). Unit: day*ug/mL

Measure	TCZ IV Q4W 7 mg/kg n = 22	TCZ IV Q4W 6 mg/kg n = 22
Value	2130 (1120 to 4300)	1610 (921 to 3070)

Population analysed: The pharmacokinetic (PK) population consisted of participants who received one dose of TCZ and had one valid PK sample, with participants grouped according to treatment received.

Primary outcome: Percentage of Participants With Adverse Events

Time frame: Baseline - Day 151. Number. Unit: Percentage of Participants

Measure	TCZ IV Q4W 7 mg/kg n = 24	TCZ IV Q4W 6 mg/kg n = 22
Value	79.2	40.9

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline - Day 151. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TCZ IV 7 mg/kg Q4W	3 of 24 (12.5%)	6 of 24 (25%)	0 of 24
TCZ IV 6 mg/kg Q4W	1 of 22 (4.5%)	3 of 22 (13.6%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35659282Schmitt 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.
Individual participant dataSharing planned: Yes. 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).

Related trials for Giant Cell Arteritis

Recruiting
Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
Polymyalgia Rheumatica (PMR)
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tocilizumab in people with Giant Cell Arteritis, run by Hoffmann-La Roche at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Serum Concentration (Cmax) of TCZ (time frame: Baseline; Weeks 4, 8, 12, 16-24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03923738, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.