Trial · NCT04633447
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
NCT04633447, Phase 2, Terminated, Janssen Research & Development, LLC; results first posted 2025-07-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis. Trials, record NCT04633447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04633447
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
- NCT number
- NCT04633447
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Giant Cell Arteritis
- Interventions
- Guselkumab, Placebo
- First posted
- 2020-11-18
- Last updated
- 2025-07-01
- Other registries' IDs
- eudract:2020-000622-26
- Results first posted
- 2025-07-01
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28 | Week 28 | GC free remission at Week 28 was defined as (1) no signs or symptoms of active Giant cell arteritis (GCA) at Week 28; (2) absence of GCA flare from first dose of the study drug through Week 28; and (3) adherence to the protocol specified 26-week GC taper regimen. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. |
| Secondary | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | GC free remission was defined as (1) no signs or symptoms of active GCA at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively; (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52; (3) adherence to the protocol specified 26-week GC taper regimen. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. |
| Secondary | Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active GCA at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52 (3) adherence to the protocol specified 26-week GC taper regimen. Normalization of ESR was defined as ESR less than (\<) 30 millimeter per hour (mm/hr) at Weeks 28, 32, 36, 40, 44, 48 and 52. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. |
| Secondary | Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active Giant cell arteritis (GCA) at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52 (3) adherence to the protocol specified 26-week GC taper regimen. Normalization of CRP is defined as CRP \<10 milligrams per liter (mg/L) or \<1 milligrams per deciliter (mg/dL). GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. |
| Secondary | Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | GC-free remission at Weeks 28, 32, 36, 40, 44, 48 and 52 was defined as (1) no signs or symptoms of active GCA at Weeks 28, 32, 36, 40, 44, 48 and 52 respectively; (2) absence of GCA flare from first dose of the study drug through Weeks 28, 32, 36, 40, 44, 48 and 52; (3) adherence to the protocol specified 26-week GC taper regimen. Normalization of ESR is defined as ESR \< 30 mm/hr at Weeks 28, 32, 36, 40, 44, 48 and 52. Normalization of CRP is defined as CRP \<10 mg/L or \<1 mg/dL. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. |
| Secondary | Main Study: Cumulative Glucocorticoid (GC) Dose | Baseline (Day 1) up to Weeks 28 and 52 | Total cumulative GC dose administered included GCA taper, GC rescue therapy as well as for all other indications (any oral GC) from baseline (Day 1) up to Weeks 28 and 52 was reported. |
| Secondary | Main Study: Time to First GCA Disease Flare or Discontinuation of Study Intervention Due to Adverse Event (AE) of Worsening of GCA | Baseline (Day 1) up to Week 30 and Week 52 | Time to occurrence of GCA disease flare was defined as the time from first dose of the study agent to the occurrence of the first observation of GCA disease flare or discontinuation due to adverse event (AE) of worsening of GCA. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. |
| Secondary | Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA | Baseline (Day 1) up to Week 30 and Week 52 | Number of participants with GCA disease flares or discontinuation of study intervention due to AE of worsening of GCA were reported. GCA flare was defined as the recurrence of signs and symptoms of active GCA, with or without elevation of inflammatory markers, and with the necessity for an increase in GC dose for GCA. |
| Secondary | Main Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline (Day 1) up to Week 60 | Number of participants with TEAEs (including serious and non-serious AEs) were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent. |
| Secondary | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Baseline (Day 1) up to Week 60 | Number of participants with TEAEs (including serious and non-serious AEs) by SOC with a frequency threshold of 5 percent (%) or more were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent. |
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 | Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28 | Week 28 | Full analysis set (FAS) included all randomized participants who received at least 1 administration of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | FAS included all randomized participants who received at least 1 administration of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Erythrocyte Sedimentation Rate (ESR) at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | FAS included all randomized participants who received at least 1 administration of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of C-Reactive Protein (CRP) at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | FAS included all randomized participants who received at least 1 administration of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving Both GC-Free Remission and Normalization of Both ESR and CRP at Weeks 28, 32, 36, 40, 44, 48 and 52 | Weeks 28, 32, 36, 40, 44, 48 and 52 | FAS included all randomized participants who received at least 1 administration of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | Main Study: Cumulative Glucocorticoid (GC) Dose | Baseline (Day 1) up to Weeks 28 and 52 | FAS included all randomized participants who received at least 1 administration of study intervention. | Milligrams (mg) | MEDIAN |
| SECONDARY | Main Study: Time to First GCA Disease Flare or Discontinuation of Study Intervention Due to Adverse Event (AE) of Worsening of GCA | Baseline (Day 1) up to Week 30 and Week 52 | FAS included all randomized participants who received at least 1 administration of study intervention. Here, N (Overall Number of Participants analyzed) signifies participants with at least 1 disease flare or discontinuation of study intervention due to AE of Worsening of GCA. | Weeks | MEDIAN |
| SECONDARY | Main Study: Number of Participants With GCA Disease Flares or Discontinuation of Study Intervention Due to AE of Worsening of GCA | Baseline (Day 1) up to Week 30 and Week 52 | FAS included all randomized participants who received at least 1 administration of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Main Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline (Day 1) up to Week 60 | Safety analysis set included all participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | Baseline (Day 1) up to Week 60 | Safety analysis set included all participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group158
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28 | Main Study: Guselkumab | 40.0 | Percentage of Participants | ||
| Main Study: Percentage of Participants Achieving Glucocorticoid (GC)-Free Remission at Week 28 | Main Study: Placebo | 33.3 | Percentage of Participants | ||
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Main Study: Guselkumab | At Week 28 | 40.0 | Percentage of Participants | |
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Main Study: Placebo | At Week 28 | 33.3 | Percentage of Participants | |
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Main Study: Guselkumab | At Week 32 | 34.3 | Percentage of Participants | |
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Main Study: Placebo | At Week 32 | 33.3 | Percentage of Participants | |
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Main Study: Guselkumab | At Week 36 | 34.3 | Percentage of Participants | |
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Main Study: Placebo | At Week 36 | 33.3 | Percentage of Participants | |
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Main Study: Guselkumab | At Week 40 | 34.3 | Percentage of Participants | |
| Main Study: Percentage of Participants Achieving GC-Free Remission at Weeks 28, 32, 36, 40, 44, 48 and 52 | Main Study: Placebo | At Week 40 | 33.3 | Percentage of Participants |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study (From Week 0 up to Week 60) | STARTED | Guselkumab | 35 | |
| Main Study (From Week 0 up to Week 60) | STARTED | Placebo | 18 | |
| Main Study (From Week 0 up to Week 60) | Participants Enrolled Post PA-5 Who Received Placebo Matching to Guselkumab 200 mg From Week 0 | Guselkumab | 0 | |
| Main Study (From Week 0 up to Week 60) | Participants Enrolled Post PA-5 Who Received Placebo Matching to Guselkumab 200 mg From Week 0 | Placebo | 11 | |
| Main Study (From Week 0 up to Week 60) | Participants Enrolled Post PA-5 Who Received Guselkumab 200 mg From Week 0 | Guselkumab | 19 | |
| Main Study (From Week 0 up to Week 60) | Participants Enrolled Post PA-5 Who Received Guselkumab 200 mg From Week 0 | Placebo | 0 | |
| Main Study (From Week 0 up to Week 60) | COMPLETED | Guselkumab | 22 | |
| Main Study (From Week 0 up to Week 60) | COMPLETED | Placebo | 12 | |
| Main Study (From Week 0 up to Week 60) | NOT COMPLETED | Guselkumab | 13 | |
| Main Study (From Week 0 up to Week 60) | NOT COMPLETED | Placebo | 6 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events412
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 | Myocarditis | Cardiac disorders | Main Study: Guselkumab | 0 | 35 | |
| other | Myocarditis | Cardiac disorders | Main Study: Placebo | 1 | 18 | |
| other | Myocarditis | Cardiac disorders | LTE Period: Guselkumab | 0 | 9 | |
| other | Myocarditis | Cardiac disorders | LTE Period: Placebo | 0 | 6 | |
| other | Ventricular Extrasystoles | Cardiac disorders | Main Study: Guselkumab | 0 | 35 | |
| other | Ventricular Extrasystoles | Cardiac disorders | Main Study: Placebo | 1 | 18 | |
| other | Ventricular Extrasystoles | Cardiac disorders | LTE Period: Guselkumab | 0 | 9 | |
| other | Ventricular Extrasystoles | Cardiac disorders | LTE Period: Placebo | 0 | 6 | |
| other | Ventricular Tachycardia | Cardiac disorders | Main Study: Guselkumab | 0 | 35 | |
| other | Ventricular Tachycardia | Cardiac disorders | Main Study: Placebo | 1 | 18 |
1 to 10 of 412Source ClinicalTrials.gov
See all 412 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Main Study: Guselkumab | 1 | 35 |
| Total, all-cause mortality | Main Study: Placebo | 0 | 18 |
| Total, all-cause mortality | LTE Period: Guselkumab | 0 | 9 |
| Total, all-cause mortality | LTE Period: Placebo | 0 | 6 |
| Total, other adverse events | Main Study: Guselkumab | 31 | 35 |
| Total, other adverse events | Main Study: Placebo | 17 | 18 |
| Total, other adverse events | LTE Period: Guselkumab | 6 | 9 |
| Total, other adverse events | LTE Period: Placebo | 5 | 6 |
| Total, serious adverse events | Main Study: Guselkumab | 6 | 35 |
| Total, serious adverse events | Main Study: Placebo | 0 | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Main Study: Guselkumab vs Main Study: Placebo: Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs) | Trial comparisons |
| Main Study: Guselkumab vs Main Study: Placebo: Main Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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.
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/NCT04633447
GET https://conductscience.org/api/trials/v1/NCT04633447/results?page=2