Trial · NCT04633447
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Main Study: Number of Participants With Treatment-emergent Serious Adverse Event (SAEs) | Baseline (Day 1) up to Week 60 | Number of participants with treatment emergent SAEs were reported. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE occurred at or after the initial administration of study intervention through the end of the main study was considered to be treatment emergent. |
| Secondary | Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Baseline (Day 1) up to Week 60 | Number of participants with clinically significant abnormalities in vital signs were reported. Clinically significant abnormal vital signs criteria: Pulse rate: \<50 beats per minutes (bpm) and with greater than (\>) 20 bpm decrease from baseline, \>115 bpm and with \>30 bpm increase from baseline; Systolic blood pressure (SBP): \<90 millimeters of mercury \[mmHg\] and with \>30 mmHg decrease from baseline, \>150 mmHg and with \>40 mmHg increase from baseline; Diastolic blood pressure (DBP): \<50 mmHg and with \>20 mmHg decrease from baseline, \>95 mmHg and with \>30 mmHg increase from baseline; Interarm blood pressure: Interarm blood pressure difference greater than or equal to (\>=) 15 mmHg in systolic blood pressure at 3 consecutive visits; Temperature (Temp): \>38.4 Degree Celsius (C) and with \>=1 C increase from baseline; Weight (kilogram \[kg\]): decrease 10 percent (%) from baseline, increase 10% from baseline; Respiratory Rate: \>20 breaths per minute. |
| Secondary | Main Study: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Baseline (Day 1) up to Week 60 | Number of participants with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or 4 abnormalities in clinical laboratory tests: hematology and chemistry were reported. Clinical laboratory abnormalities of living participants were assessed as per NCI CTCAE version 5, grades (0-4), where Grade 0-Normal, Grade 1- Mild, Grade 2- Moderate, Grade 3- Severe or medically significant but not immediately life-threatening, Grade 4- Life-threatening consequences. Higher grades showed severe abnormality. As per the discretion of investigator, laboratory abnormalities with NCI CTCAE Grade 3 or 4 were considered clinically significant. Combined data of Grade 3 and 4 abnormalities are reported as planned. Only those categories in which at least 1 participant had data were reported. |
| Secondary | Main Study: Serum Concentrations of Guselkumab | Pre-dose and 1 hour post dose on Week 0 (Day 1), Week 4 (Day 28), and Week 8 (Day 56); Week 12 (Day 84), Week 16 (Day 112), Week 28 (Day 196), Week 52 (Day 364) | Serum concentrations of Guselkumab over time was reported. |
| Secondary | Main Study: Number of Participants With Antibodies to Guselkumab | Baseline (Day 1) up to Week 28, Week 52 | Number of participants with antibodies to Guselkumab were reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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