Trial · NCT01791153
An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
NCT01791153, Phase 3, Completed, Hoffmann-La Roche; results first posted 2017-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA). Trials, record NCT01791153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01791153
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
- NCT number
- NCT01791153
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 251 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Giant Cell Arteritis
- Interventions
- Tocilizumab, Prednisone, Tocilizumab Placebo, Prednisone Placebo, Corticosteroids, Methotrexate
- First posted
- 2013-02-13
- Last updated
- 2020-02-06
- Other registries' IDs
- eudract:2011-006022-25
- Results first posted
- 2017-05-18
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) | Week 52 | Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than \[\<\] 1 milligram per deciliter \[mg/dL\]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) attributable to GCA. A single CRP elevation (\>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (\>/=1 mg/dL) at the next study visit. |
| Secondary | Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper) | Week 52 | Remission was defined as the absence of flare and normalization of the CRP (\<1 mg/dL). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR \>/=30 mm/hr attributable to GCA. A single CRP elevation (\>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (\>/=1 mg/dL) at the next study visit. |
| Secondary | Time to First GCA Disease Flare | Up to 52 weeks | Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR \>/=30 mm/hr attributable to GCA. Participants who withdrew from the study prior to Week 52 were censored from the time of withdrawal. |
| Secondary | Total Cumulative Prednisone Dose | Up to 52 weeks | The median total cumulative prednisone dose over the 52 weeks for each treatment group and the corresponding 95% confidence intervals are presented. |
| Secondary | Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52 | Baseline, Week 52 | The SF-36 is a standardized questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Score (PCS) and Mental Component Score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A positive change from baseline indicates improvement. No imputation was used for missing data. Data was set to missing for participants who received escape therapy. |
| Secondary | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52 | Baseline, Week 52 | Participants assessed their current disease activity on a 0-100 millimeter (mm) VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity. A negative change from baseline indicates improvement. |
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab | Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) | AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval. AUCtau is measured in microgram\*day per milliliter (mcg\*day/mL). |
| Secondary | Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab | Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) | Cmax,ss is maximum model-predicted serum steady state concentration of tocilizumab measured in micrograms per milliliter (mcg/mL). |
| Secondary | Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab | Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) | Cmin,ss is minimum model-predicted serum steady state concentration of tocilizumab measured in mcg/mL. |
| Secondary | Minimum Observed Serum Concentration (Ctrough) of Tocilizumab | Predose (Hour 0) at Baseline and Week 52 | Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) | Week 52 | Intent-to-treat (ITT) population included all participants randomized into the study who received at least one administration of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper) | Week 52 | ITT population | percentage of participants | NUMBER |
| SECONDARY | Time to First GCA Disease Flare | Up to 52 weeks | ITT population | days | MEDIAN |
| SECONDARY | Total Cumulative Prednisone Dose | Up to 52 weeks | ITT Population | milligrams (mg) | MEDIAN |
| SECONDARY | Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52 | Baseline, Week 52 | ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52 | Baseline, Week 52 | ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively. | mm | MEAN |
| SECONDARY | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab | Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) | Pharmacokinetics (PK)-evaluable population included all participants who received at least one tocilizumab injection and had at least one PK sample with detectable results taken at any time during the study. | mcg*day/mL | MEAN |
| SECONDARY | Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab | Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) | PK-evaluable population | mcg/mL | MEAN |
| SECONDARY | Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab | Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0]) | PK-evaluable population | mcg/mL | MEAN |
| SECONDARY | Minimum Observed Serum Concentration (Ctrough) of Tocilizumab | Predose (Hour 0) at Baseline and Week 52 | PK-evaluable population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively. | mcg/mL | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 56.0 | percentage of participants | ||
| Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 53.1 | percentage of participants | ||
| Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) | Part 1: Placebo + 26 Weeks Prednisone Taper | 14.0 | percentage of participants | ||
| Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper) | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 56.0 | percentage of participants | ||
| Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper) | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 53.1 | percentage of participants | ||
| Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper) | Part 1: Placebo + 52 Weeks Prednisone Taper | 17.6 | percentage of participants | ||
| Time to First GCA Disease Flare | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | NA | 99% Confidence Interval NA to NA | days | |
| Time to First GCA Disease Flare | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | NA | 99% Confidence Interval NA to NA | days | |
| Time to First GCA Disease Flare | Part 1: Placebo + 26 Weeks Prednisone Taper | 165.0 | 99% Confidence Interval 120.0 to 260.0 | days | |
| Time to First GCA Disease Flare | Part 1: Placebo + 52 Weeks Prednisone Taper | 295.0 | 99% Confidence Interval 168.0 to NA | days |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Blinded Period | STARTED | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 100 | |
| Part 1: Blinded Period | STARTED | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 49 | |
| Part 1: Blinded Period | STARTED | Part 1: Placebo + 26 Weeks Prednisone Taper | 50 | |
| Part 1: Blinded Period | STARTED | Part 1: Placebo + 52 Weeks Prednisone Taper | 51 | |
| Part 1: Blinded Period | STARTED | Part 2: No Tocilizumab (Placebo in Part 1) | 0 | |
| Part 1: Blinded Period | STARTED | Part 2: No Tocilizumab (Tocilizumab in Part 1) | 0 | |
| Part 1: Blinded Period | STARTED | Part 2: Tocilizumab (Placebo in Part 1) | 0 | |
| Part 1: Blinded Period | STARTED | Part 2: Tocilizumab (Tocilizumab in Part 1) | 0 | |
| Part 1: Blinded Period | COMPLETED | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 85 | |
| Part 1: Blinded Period | COMPLETED | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 41 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events1,624
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 | Palpitations | Cardiac disorders | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 2 | 100 | |
| other | Palpitations | Cardiac disorders | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 2 | 49 | |
| other | Palpitations | Cardiac disorders | Part 1: Placebo + 26 Weeks Prednisone Taper | 4 | 50 | |
| other | Palpitations | Cardiac disorders | Part 1: Placebo + 52 Weeks Prednisone Taper | 2 | 51 | |
| other | Palpitations | Cardiac disorders | Part 2: No Tocilizumab (Placebo in Part 1) | 0 | 40 | |
| other | Palpitations | Cardiac disorders | Part 2: No Tocilizumab (Tocilizumab in Part 1) | 0 | 58 | |
| other | Palpitations | Cardiac disorders | Part 2: Tocilizumab (Placebo in Part 1) | 0 | 50 | |
| other | Palpitations | Cardiac disorders | Part 2: Tocilizumab (Tocilizumab in Part 1) | 0 | 67 | |
| other | Vertigo | Ear and labyrinth disorders | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 2 | 100 | |
| other | Vertigo | Ear and labyrinth disorders | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 1 | 49 |
1 to 10 of 1,624Source ClinicalTrials.gov
See all 1,624 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | ||
| Total, all-cause mortality | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | ||
| Total, all-cause mortality | Part 1: Placebo + 26 Weeks Prednisone Taper | ||
| Total, all-cause mortality | Part 1: Placebo + 52 Weeks Prednisone Taper | ||
| Total, all-cause mortality | Part 2: No Tocilizumab (Placebo in Part 1) | ||
| Total, all-cause mortality | Part 2: No Tocilizumab (Tocilizumab in Part 1) | ||
| Total, all-cause mortality | Part 2: Tocilizumab (Placebo in Part 1) | ||
| Total, all-cause mortality | Part 2: Tocilizumab (Tocilizumab in Part 1) | ||
| Total, other adverse events | Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper | 87 | 100 |
| Total, other adverse events | Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper | 44 | 49 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01791153
GET https://conductscience.org/api/trials/v1/NCT01791153/results?page=2