Trial · NCT01450137

Tocilizumab for Patients With Giant Cell Arteritis

NCT01450137, Phase 2, Completed, Insel Gruppe AG, University Hospital Bern; results first posted 2019-02-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Tocilizumab for Patients With Giant Cell Arteritis. Trials, record NCT01450137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01450137

On this page

Trial

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

Title: Tocilizumab for Patients With Giant Cell Arteritis
NCT number: NCT01450137
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Conditions: Giant Cell Arteritis
Interventions: Tocilizumab + Glucocorticoids (GCs), Placebo + Glucocorticoids (GCs)
First posted: 2011-10-12
Last updated: 2019-02-12
Results first posted: 2019-02-12

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Number of Patients That Have Achieved Complete Remission of Disease	12 weeks
Secondary	Number of Relapse Free Patients	12 months
Secondary	Cumulative Dose of GCs in mg/kg	12 months	cumulative weight-adapted prednisolone dose
Secondary	Restricted Mean Survival Time to First Relapse After Induction of Remission	12 months

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients That Have Achieved Complete Remission of Disease	12 weeks	All randomized patients, intention-to-treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Relapse Free Patients	12 months	All randomized patients, intention-to-treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cumulative Dose of GCs in mg/kg	12 months	All randomized patients, intention-to-treat	mg/kg	MEDIAN
SECONDARY	Restricted Mean Survival Time to First Relapse After Induction of Remission	12 months	All randomized patients, intention-to-treat	Weeks	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Number of Patients That Have Achieved Complete Remission of Disease	Tocilizumab	17		Participants
Number of Patients That Have Achieved Complete Remission of Disease	Placebo	4		Participants
Number of Relapse Free Patients	Tocilizumab	17		Participants
Number of Relapse Free Patients	Placebo	2		Participants
Cumulative Dose of GCs in mg/kg	Tocilizumab	43	Inter-Quartile Range 39 to 52	mg/kg
Cumulative Dose of GCs in mg/kg	Placebo	110	Inter-Quartile Range 88 to 150	mg/kg
Restricted Mean Survival Time to First Relapse After Induction of Remission	Tocilizumab	50	95% Confidence Interval 46 to 54	Weeks
Restricted Mean Survival Time to First Relapse After Induction of Remission	Placebo	25	95% Confidence Interval 11 to 38	Weeks

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Up to Week 12	STARTED	Tocilizumab	20
Up to Week 12	STARTED	Placebo	10
Up to Week 12	COMPLETED	Tocilizumab	18
Up to Week 12	COMPLETED	Placebo	7
Up to Week 12	NOT COMPLETED	Tocilizumab	2
Up to Week 12	NOT COMPLETED	Placebo	3
Week 12 to Study End	STARTED	Tocilizumab	18
Week 12 to Study End	STARTED	Placebo	7
Week 12 to Study End	COMPLETED	Tocilizumab	18
Week 12 to Study End	COMPLETED	Placebo	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events30

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	Cardiovascular disease	Cardiac disorders	Tocilizumab	0	20	0
other	Cardiovascular disease	Cardiac disorders	Placebo	2	10	2
other	Cystic lesion mamma	Reproductive system and breast disorders	Tocilizumab	1	20	1
other	Cystic lesion mamma	Reproductive system and breast disorders	Placebo	0	10	0
other	Gastrointestinal disease	Gastrointestinal disorders	Tocilizumab	1	20	1
other	Gastrointestinal disease	Gastrointestinal disorders	Placebo	0	10	0
other	Glucocorticoid-related hyperglycaemia and myopathia	Blood and lymphatic system disorders	Tocilizumab	1	20	2
other	Glucocorticoid-related hyperglycaemia and myopathia	Blood and lymphatic system disorders	Placebo	1	10	1
other	Infectious disease	Infections and infestations	Tocilizumab	7	20	9
other	Infectious disease	Infections and infestations	Placebo	1	10	1

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tocilizumab	0	20
Total, all-cause mortality	Placebo	1	10
Total, other adverse events	Tocilizumab	11	20
Total, other adverse events	Placebo	6	10
Total, serious adverse events	Tocilizumab	7	20
Total, serious adverse events	Placebo	5	10

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26952547	RESULT	PubMed
29961816	DERIVED	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 comparisons4

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

Comparison	Source
Tocilizumab vs Placebo: Number of Relapse Free Patients	Trial comparisons
Tocilizumab vs Placebo: Number of Patients That Have Achieved Complete Remission of Disease	Trial comparisons
Tocilizumab vs Placebo: deaths from any cause	Trial comparisons
Tocilizumab vs Placebo: 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/NCT01450137

GET https://conductscience.org/api/trials/v1/NCT01450137/events?page=2

API reference For AI assistants