Trial · NCT03923738

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

NCT03923738, Phase 1, Completed, Hoffmann-La Roche; results first posted 2021-12-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA). Trials, record NCT03923738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03923738

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
NCT number: NCT03923738
Status: Completed
Phases: Phase 1
Enrollment: 24 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Giant Cell Arteritis
Interventions: Tocilizumab
First posted: 2019-04-23
Last updated: 2021-12-22
Other registries' IDs: eudract:2018-004718-17
Results first posted: 2021-12-22

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Maximum Serum Concentration (Cmax) of TCZ	Baseline; Weeks 4, 8, 12, 16-24
Primary	Trough Serum Concentration (Ctrough) of TCZ at Steady State	Baseline; Weeks 4, 8, 12, 16-24
Primary	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
Primary	Percentage of Participants With Adverse Events	Baseline - Day 151
Secondary	Serum Concentration of Interleukin-6 (IL-6)	Baseline; Weeks 12, 16, 20, 24
Secondary	Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)	Baseline; Weeks 12, 16, 20, 24
Secondary	Serum Concentration of C-Reactive Protein (CRP)	Baseline; Weeks 4, 8, 12, 16-24
Secondary	Erythrocyte Sedimentation Rate (ESR)	Baseline; Weeks 4, 8, 12, 16-24

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Serum Concentration (Cmax) of TCZ	Baseline; Weeks 4, 8, 12, 16-24	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.	ug/mL	MEDIAN
PRIMARY	Trough Serum Concentration (Ctrough) of TCZ at Steady State	Baseline; Weeks 4, 8, 12, 16-24	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.	ug/mL	MEDIAN
PRIMARY	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	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.	day*ug/mL	MEDIAN
PRIMARY	Percentage of Participants With Adverse Events	Baseline - Day 151		Percentage of Participants	NUMBER
SECONDARY	Serum Concentration of Interleukin-6 (IL-6)	Baseline; Weeks 12, 16, 20, 24	The pharmacodynamic (PD) population was identical to the safety analysis population, which consisted of participants who received at least one dose of study drug and had at least one safety assessment.	pg/mL	MEAN
SECONDARY	Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)	Baseline; Weeks 12, 16, 20, 24	The pharmacodynamic (PD) population was identical to the safety analysis population, which consisted of participants who received at least one dose of study drug and had at least one safety assessment.	ng/mL	MEAN
SECONDARY	Serum Concentration of C-Reactive Protein (CRP)	Baseline; Weeks 4, 8, 12, 16-24	The pharmacodynamic (PD) population was identical to the safety analysis population, which consisted of participants who received at least one dose of study drug and had at least one safety assessment.	mg/L	MEAN
SECONDARY	Erythrocyte Sedimentation Rate (ESR)	Baseline; Weeks 4, 8, 12, 16-24	The pharmacodynamic (PD) population was identical to the safety analysis population, which consisted of participants who received at least one dose of study drug and had at least one safety assessment.	mm/h	MEAN

Source ClinicalTrials.gov

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Maximum Serum Concentration (Cmax) of TCZ	TCZ IV Q4W 7 mg/kg		197	Full Range 118 to 352	ug/mL
Maximum Serum Concentration (Cmax) of TCZ	TCZ IV Q4W 6 mg/kg		178	Full Range 115 to 320	ug/mL
Trough Serum Concentration (Ctrough) of TCZ at Steady State	TCZ IV Q4W 7 mg/kg		37.2	Full Range 6.59 to 69.0	ug/mL
Trough Serum Concentration (Ctrough) of TCZ at Steady State	TCZ IV Q4W 6 mg/kg		22.7	Full Range 3.38 to 54.5	ug/mL
Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State	TCZ IV Q4W 7 mg/kg		2130	Full Range 1120 to 4300	day*ug/mL
Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State	TCZ IV Q4W 6 mg/kg		1610	Full Range 921 to 3070	day*ug/mL
Percentage of Participants With Adverse Events	TCZ IV Q4W 7 mg/kg		79.2		Percentage of Participants
Percentage of Participants With Adverse Events	TCZ IV Q4W 6 mg/kg		40.9		Percentage of Participants
Serum Concentration of Interleukin-6 (IL-6)	TCZ IV Q4W 7 mg/kg	Baseline	57.80	Standard Deviation 61.149	pg/mL
Serum Concentration of Interleukin-6 (IL-6)	TCZ IV Q4W 6 mg/kg	Baseline	39.46	Standard Deviation 25.989	pg/mL

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	TCZ IV Q4W	24
Period 1	COMPLETED	TCZ IV Q4W	22
Period 1	NOT COMPLETED	TCZ IV Q4W	2
Period 2	STARTED	TCZ IV Q4W	22
Period 2	COMPLETED	TCZ IV Q4W	22
Period 2	NOT COMPLETED	TCZ IV Q4W	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	TCZ IV 7 mg/kg Q4W	3	24	3
other	Nasopharyngitis	Infections and infestations	TCZ IV 6 mg/kg Q4W	1	22	1
other	Respiratory tract infection viral	Infections and infestations	TCZ IV 7 mg/kg Q4W	1	24	1
other	Respiratory tract infection viral	Infections and infestations	TCZ IV 6 mg/kg Q4W	2	22	2
other	Upper respiratory tract infection	Infections and infestations	TCZ IV 7 mg/kg Q4W	2	24	2
other	Upper respiratory tract infection	Infections and infestations	TCZ IV 6 mg/kg Q4W	0	22	0
serious	Vertigo positional	Ear and labyrinth disorders	TCZ IV 7 mg/kg Q4W	0	24	0
serious	Vertigo positional	Ear and labyrinth disorders	TCZ IV 6 mg/kg Q4W	1	22	1
serious	Lower gastrointestinal haemorrhage	Gastrointestinal disorders	TCZ IV 7 mg/kg Q4W	1	24	1
serious	Lower gastrointestinal haemorrhage	Gastrointestinal disorders	TCZ IV 6 mg/kg Q4W	0	22	0

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TCZ IV 7 mg/kg Q4W	0	24
Total, all-cause mortality	TCZ IV 6 mg/kg Q4W	0	22
Total, other adverse events	TCZ IV 7 mg/kg Q4W	6	24
Total, other adverse events	TCZ IV 6 mg/kg Q4W	3	22
Total, serious adverse events	TCZ IV 7 mg/kg Q4W	3	24
Total, serious adverse events	TCZ IV 6 mg/kg Q4W	1	22

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35659282	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
TCZ IV 7 mg/kg Q4W vs TCZ IV 6 mg/kg Q4W: deaths from any cause	Trial comparisons
TCZ IV 7 mg/kg Q4W vs TCZ IV 6 mg/kg Q4W: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03923738

GET https://conductscience.org/api/trials/v1/NCT03923738/results?page=2

API reference For AI assistants