Trial · NCT03600805
Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
NCT03600805, Phase 3, Terminated, Sanofi; results first posted 2022-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA. Trials, record NCT03600805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03600805
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
- NCT number
- NCT03600805
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 83 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Giant Cell Arteritis
- Interventions
- Sarilumab SAR153191, Sarilumab matching placebo, Prednisone, Prednisone matching placebo
- First posted
- 2018-07-26
- Last updated
- 2022-03-28
- Other registries' IDs
- eudract:2017-002988-18
- Results first posted
- 2022-01-14
- Limitations and caveats
- Study was prematurely discontinued due to protracted enrolment exacerbated by Covid-19 pandemic situation and not due to any safety issues from administration of sarilumab.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 | At Week 52 | Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (\<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid \[CS\] dose due to GCA or elevation of erythrocyte sedimentation rate \[ESR\] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalization of CRP (to \<10 mg/L, with absence of successive elevations to \>=10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52. |
| Primary | Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 | At Week 24 | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP \<10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalization of CRP (to \<10 mg/L, with an absence of successive elevations to \>=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24. |
| Secondary | Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set | Up to Week 12 | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (\< 10 mg/L). The status of normalization of CRP (\<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was \<10 mg/L, then it was considered as normalization of CRP. Participants who took rescue corticosteroid (CS) due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. |
| Secondary | Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population | Up to Week 12 | Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (\< 10 mg/L). The status of normalization of CRP (\<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was \<10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. |
| Secondary | Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set | From Week 12 through Week 52 | Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 52 were reported. |
| Secondary | Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population | From Week 12 through Week 24 | Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 24 were reported. |
| Secondary | Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set | From Week 12 through Week 52 | Normalization of CRP was defined as CRP levels \<10 mg/L. If there were two or more consecutive visits with CRP \>=10 mg/L, then it was categorized as no normalization of CRP. |
| Secondary | Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population | From Week 12 through Week 24 | Normalization of CRP was defined as CRP levels \<10 mg/L. If there were two or more consecutive visits with CRP \>=10 mg/L, then it was categorized as no normalization of CRP. |
| Secondary | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set | From Week 12 through Week 52 | Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of \<=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to GCA. |
| Secondary | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population | From Week 12 through Week 24 | Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as participants who did not take rescue therapy from Week 12 through Week 24 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of \<=100 mg (or equivalent), such as those employed to manage AE not related to GCA. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 | At Week 52 | Analysis was performed on Week 52 analysis set population that included randomized participants who had opportunity to complete the 52-week treatment period (randomized prior to October 16th, 2019). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 | At Week 24 | Analysis was performed on intent-to-treat (ITT) population that included participants who were allocated to a randomized treatment regardless of whether the treatment kit was used, and were analyzed according to the treatment group allocated by randomization. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set | Up to Week 12 | Analysis was performed on Week 52 analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population | Up to Week 12 | Analysis was performed on ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set | From Week 12 through Week 52 | Analysis was performed on Week 52 analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population | From Week 12 through Week 24 | Analysis was performed on ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set | From Week 12 through Week 52 | Analysis was performed on Week 52 analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population | From Week 12 through Week 24 | Analysis was performed on ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set | From Week 12 through Week 52 | Analysis was performed on Week 52 analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population | From Week 12 through Week 24 | Analysis was performed on ITT population. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group220
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 | Placebo+52 Week Taper | 30.0 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 | Placebo+26 Week Taper | 0 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 | Sarilumab 150mg q2w+26 Week Taper | 42.9 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 52 | Sarilumab 200mg q2w+26 Week Taper | 46.2 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 | Placebo+52 Week Taper | 39.3 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 | Placebo+26 Week Taper | 7.1 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 | Sarilumab 150mg q2w+26 Week Taper | 42.9 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Disease Remission at Week 24 | Sarilumab 200mg q2w+26 Week Taper | 48.1 | percentage of participants | ||
| Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set | Placebo+52 Week Taper | 7 | Participants | ||
| Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set | Placebo+26 Week Taper | 3 | Participants |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo+52 Week Taper | 28 | |
| Overall Study | STARTED | Placebo+26 Week Taper | 14 | |
| Overall Study | STARTED | Sarilumab 150mg q2w+26 Week Taper | 14 | |
| Overall Study | STARTED | Sarilumab 200mg q2w+26 Week Taper | 27 | |
| Overall Study | Week 52 Analysis Set Population | Placebo+52 Week Taper | 10 | |
| Overall Study | Week 52 Analysis Set Population | Placebo+26 Week Taper | 6 | |
| Overall Study | Week 52 Analysis Set Population | Sarilumab 150mg q2w+26 Week Taper | 7 | |
| Overall Study | Week 52 Analysis Set Population | Sarilumab 200mg q2w+26 Week Taper | 13 | |
| Overall Study | COMPLETED | Placebo+52 Week Taper | 9 | |
| Overall Study | COMPLETED | Placebo+26 Week Taper | 6 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events572
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 | Increased Tendency To Bruise | Blood and lymphatic system disorders | Placebo+52 Week Taper | 5 | 28 | 5 |
| other | Increased Tendency To Bruise | Blood and lymphatic system disorders | Placebo+26 Week Taper | 3 | 14 | 3 |
| other | Increased Tendency To Bruise | Blood and lymphatic system disorders | Sarilumab 150mg q2w+26 Week Taper | 3 | 14 | 3 |
| other | Increased Tendency To Bruise | Blood and lymphatic system disorders | Sarilumab 200mg q2w+26 Week Taper | 3 | 27 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo+52 Week Taper | 0 | 28 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo+26 Week Taper | 0 | 14 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab 150mg q2w+26 Week Taper | 2 | 14 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Sarilumab 200mg q2w+26 Week Taper | 0 | 27 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | Placebo+52 Week Taper | 0 | 28 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | Placebo+26 Week Taper | 2 | 14 | 2 |
1 to 10 of 572Source ClinicalTrials.gov
See all 572 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo+52 Week Taper | 0 | 28 |
| Total, all-cause mortality | Placebo+26 Week Taper | 1 | 14 |
| Total, all-cause mortality | Sarilumab 150mg q2w+26 Week Taper | 0 | 14 |
| Total, all-cause mortality | Sarilumab 200mg q2w+26 Week Taper | 2 | 27 |
| Total, other adverse events | Placebo+52 Week Taper | 22 | 28 |
| Total, other adverse events | Placebo+26 Week Taper | 13 | 14 |
| Total, other adverse events | Sarilumab 150mg q2w+26 Week Taper | 13 | 14 |
| Total, other adverse events | Sarilumab 200mg q2w+26 Week Taper | 20 | 27 |
| Total, serious adverse events | Placebo+52 Week Taper | 2 | 28 |
| Total, serious adverse events | Placebo+26 Week Taper | 3 | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37840134 | 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 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/NCT03600805
GET https://conductscience.org/api/trials/v1/NCT03600805/registered?page=2