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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004061-39 | EudraCT Number | ||
| CNTO1959PSO4015 | Other Identifier | Janssen-Cilag Ltd. |
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Terminated (A strategic decision was made not to further execute the study. This decision was not based on a safety concern)
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The purpose of this study is to evaluate the effect of guselkumab on coronary flow reserve (CFR), measured by transthoracic doppler-echocardiography, in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk.
Psoriasis is a common chronic inflammatory disease that affects 2 percent (%)-3% of the population and has an impact on physical and emotional health-related quality-of-life that is comparable to major illnesses such as cancer, heart disease and depression. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to the p19 protein subunit of human interleukin 23 (IL-23) with high specificity and affinity. Binding of guselkumab to the IL-23 p19 subunit blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling and subsequent cytokine production. Guselkumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. This study aims to investigate the efficacy of guselkumab in reducing surrogate parameters of vascular dysfunction and cardiovascular risk. This study will consist of two Screening Visits (Screening Visit S1 at a maximum of 2 weeks prior to Screening Visit S2, to occur at a minimum of 2 weeks and maximum of 4 weeks prior to Week 0), a Treatment Phase (up to 28 weeks), Final Efficacy Visit 4 weeks later (Week 32), and Final Safety Visit (Week 40). The efficacy assessments will be done locally at the sites and safety will be monitored by assessment of adverse events, clinical laboratory tests, physical examinations, vital signs, and concomitant medication review. The total duration of the study will be 40 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guselkumab | Experimental | Participants will receive guselkumab 100 milligrams (mg) by subcutaneous injection at Weeks 0, 4, 12, 20 and 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered by subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Coronary Flow Reserve (CFR) at Week 32 | Change from baseline in CFR at Week 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 micrograms per kilogram per minute (mcg/kg/min; coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest. | Baseline (Week 0) and Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CFR at Week 16 | Change from baseline in CFR at Week 16 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd Clinical Trial | Janssen-Cilag Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinikum Frankfurt | Frankfurt | 60590 | Germany | |||
| Universitatsklinikum Leipzig AOR |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
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A total of 15 adult participants diagnosed with moderate-to-severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months prior to the first dose of guselkumab at Week 0 (baseline) of the study entry were enrolled and treated with at least one dose of guselkumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Guselkumab 100 mg: Nicotine Users | Participants who were nicotine users (who had used tobacco products and/or nicotine products) received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, 20, and 28. |
| FG001 | Guselkumab 100 mg: Non-Nicotine Users | Participants who were non-nicotine users (who had refrained from using tobacco/nicotine products for at least 3 months prior to screening visit 1 [4 to 6 weeks prior to Week 0]) received guselkumab 100 mg SC injection at Weeks 0, 4, 12, 20, and 28. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Guselkumab 100 mg: Nicotine Users | Participants who were nicotine users (who had used tobacco products and/or nicotine products) received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, 20, and 28. |
| BG001 | Guselkumab 100 mg: Non-Nicotine Users |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Coronary Flow Reserve (CFR) at Week 32 | Change from baseline in CFR at Week 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 micrograms per kilogram per minute (mcg/kg/min; coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest. | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0). | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 32 |
Week 0 up to 12 weeks post last dose of study drug (up to Week 40)
The safety analysis set included all participants who received at least 1 dose of guselkumab.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guselkumab 100 mg: Nicotine Users | Participants who were nicotine users (who had used tobacco products and/or nicotine products) received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, 20, and 28. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 26.0 | Non-systematic Assessment |
Sponsor terminated the study solely due to lack of enrolment. Due to small number of enrolled participants, it was not possible to evaluate the primary or secondary objectives for this study as planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior EMEA Medical Advisor Immunology | Janssen-Cilag Limited | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2022 | Jul 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2023 | Jul 22, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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| Baseline (Week 0) and Week 16 |
| Change From Baseline in Absolute Global Longitudinal Strain (GLS) at Week 16 | Change from baseline in absolute GLS at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. | Baseline (Week 0) and Week 16 |
| Change From Baseline in Absolute GLS at Week 32 | Change from baseline in absolute GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. | Baseline (Week 0) and Week 32 |
| Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 16 | Change from baseline in cfPWV at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds). | Baseline (Week 0) and Week 16 |
| Change From Baseline in cfPWV at Week 32 | Change from baseline in cfPWV at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds). | Baseline (Week 0) and Week 32 |
| Change From Baseline in CFR at Week 16 Among Participants With CFR >=2 to Less Than (<) 2.75 at Baseline | Change from baseline in CFR at Week 16 among participants with CFR >=2 to <2.75 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | Baseline (Week 0) and Week 16 |
| Change From Baseline in CFR at Week 32 Among Participants With CFR >=2 to <2.75 at Baseline | Change from baseline in CFR at Week 32 among participants with CFR >=2 to <2.75 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | Baseline (Week 0) and Week 32 |
| Change From Baseline in CFR at Week 16 Among Participants With CFR >=2.75 to <=3.5 at Baseline | Change from baseline in CFR at Week 16 among participants with CFR >=2.75 to <=3.5 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | Baseline (Week 0) and Week 16 |
| Change From Baseline in CFR at Week 32 Among Participants With CFR >=2.75 to <=3.5 at Baseline | Change from baseline in CFR at Week 32 among participants with CFR >=2.75 to <=3.5 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | Baseline (Week 0) and Week 32 |
| Change From Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 16 | Change from baseline in CFR among nicotine users and non-users at Week 16 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | Baseline (Week 0) and Week 16 |
| Change From Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 32 | Change from baseline in CFR among nicotine users and non-nicotine users at Weeks 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | Baseline (Week 0) and Week 32 |
| Change From Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 16 | Change from baseline in absolute GLS among nicotine users and non-nicotine users at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. | Baseline (Week 0) and Week 16 |
| Change From Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 32 | Change from baseline in absolute GLS among nicotine users and non-nicotine users at Week 32 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. | Baseline (Week 0) and Week 32 |
| Change From Baseline in cfPWV Among Nicotine Users and Non-users at Week 16 | Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds). | Baseline (Week 0) and Week 16 |
| Change From Baseline in cfPWV Among Nicotine Users and Non-users at Week 32 | Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds). | Baseline (Week 0) and Week 32 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Number of participants with TEAEs 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 initial administration study intervention (guselkumab) through the day of last dose within the study phase plus 12 weeks or the date of the Final Safety visit, whichever was the latest, was considered to be TEAE. | Week 0 up to 12 weeks post last dose of study drug (up to Week 40) |
| Leipzig |
| 4103 |
| Germany |
| Attikon Hospital | Athens | 12462 | Greece |
| Ospedale San Giovanni di Dio | Cagliari | 09123 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
Participants who were non-nicotine users (who had refrained from using tobacco/nicotine products for at least 3 months prior to screening visit 1 [4 to 6 weeks prior to Week 0]) received guselkumab 100 mg SC injection at Weeks 0, 4, 12, 20, and 28. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Change From Baseline in CFR at Week 16 | Change from baseline in CFR at Week 16 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest. | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0). | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 16 |
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| Secondary | Change From Baseline in Absolute Global Longitudinal Strain (GLS) at Week 16 | Change from baseline in absolute GLS at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0). | Posted | Mean | Standard Deviation | percentage of myocardial shortening | Baseline (Week 0) and Week 16 |
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| Secondary | Change From Baseline in Absolute GLS at Week 32 | Change from baseline in absolute GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0). | Posted | Mean | Standard Deviation | percentage of myocardial shortening | Baseline (Week 0) and Week 32 |
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| Secondary | Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 16 | Change from baseline in cfPWV at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds). | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0). | Posted | Mean | Standard Deviation | meter per second (m/s) | Baseline (Week 0) and Week 16 |
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| Secondary | Change From Baseline in cfPWV at Week 32 | Change from baseline in cfPWV at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds). | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0). | Posted | Mean | Standard Deviation | meter per second (m/s) | Baseline (Week 0) and Week 32 |
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| Secondary | Change From Baseline in CFR at Week 16 Among Participants With CFR >=2 to Less Than (<) 2.75 at Baseline | Change from baseline in CFR at Week 16 among participants with CFR >=2 to <2.75 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2 to <2.75 at baseline (Week 0). None of the nicotine users had the baseline CFR measurement of >=2 to <2.75 and thus, no data was reported for arm 'Guselkumab 100 mg: Nicotine Users'. | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 16 |
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| Secondary | Change From Baseline in CFR at Week 32 Among Participants With CFR >=2 to <2.75 at Baseline | Change from baseline in CFR at Week 32 among participants with CFR >=2 to <2.75 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2 to <2.75 at baseline (Week 0). None of the nicotine users had the baseline CFR measurement of >=2 to <2.75 and thus, no data was reported for arm 'Guselkumab 100 mg: Nicotine Users'. | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 32 |
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| Secondary | Change From Baseline in CFR at Week 16 Among Participants With CFR >=2.75 to <=3.5 at Baseline | Change from baseline in CFR at Week 16 among participants with CFR >=2.75 to <=3.5 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2.75 to <=3.5 at baseline (Week 0). None of the non-nicotine users had the baseline CFR measurement of >=2.75 to <=3.5 and thus, no data was reported for arm 'Guselkumab 100 mg: Non-Nicotine Users'. | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 16 |
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| Secondary | Change From Baseline in CFR at Week 32 Among Participants With CFR >=2.75 to <=3.5 at Baseline | Change from baseline in CFR at Week 32 among participants with CFR >=2.75 to <=3.5 at baseline were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of treated participants evaluable for this outcome measure with ICR defined by CFR >=2.75 to <=3.5 at baseline (Week 0). None of the non-nicotine users had the baseline CFR measurement of >=2.75 to <=3.5 and thus, no data was reported for arm 'Guselkumab 100 mg: Non-Nicotine Users'. | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 32 |
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| Secondary | Change From Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 16 | Change from baseline in CFR among nicotine users and non-users at Week 16 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 16 |
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| Secondary | Change From Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 32 | Change from baseline in CFR among nicotine users and non-nicotine users at Weeks 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 mcg/kg/min (coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0) and Week 32 |
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| Secondary | Change From Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 16 | Change from baseline in absolute GLS among nicotine users and non-nicotine users at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of myocardial shortening | Baseline (Week 0) and Week 16 |
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| Secondary | Change From Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 32 | Change from baseline in absolute GLS among nicotine users and non-nicotine users at Week 32 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of myocardial shortening | Baseline (Week 0) and Week 32 |
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| Secondary | Change From Baseline in cfPWV Among Nicotine Users and Non-users at Week 16 | Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds). | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | meter per second (m/s) | Baseline (Week 0) and Week 16 |
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| Secondary | Change From Baseline in cfPWV Among Nicotine Users and Non-users at Week 32 | Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds). | FAS included all participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | meter per second (m/s) | Baseline (Week 0) and Week 32 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Number of participants with TEAEs 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 initial administration study intervention (guselkumab) through the day of last dose within the study phase plus 12 weeks or the date of the Final Safety visit, whichever was the latest, was considered to be TEAE. | The safety analysis set included all participants who received at least 1 dose of guselkumab. | Posted | Count of Participants | Participants | Week 0 up to 12 weeks post last dose of study drug (up to Week 40) |
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| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Guselkumab 100 mg: Non-Nicotine Users | Participants who were non-nicotine users (who had refrained from using tobacco/nicotine products for at least 3 months prior to screening visit 1 [4 to 6 weeks prior to Week 0]) received guselkumab 100 mg SC injection at Weeks 0, 4, 12, 20, and 28. | 0 | 8 | 1 | 8 | 2 | 8 |
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. If requested by the Sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.