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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002389-33 | EudraCT Number | ||
| CNTO1959CRD3007 | Other Identifier | Janssen Research & Development, LLC |
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Janssen made an internal business decision to discontinue the PROGRESS study. This decision is not related to any efficacy or safety concerns.
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The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Guselkumab | Active Comparator | Participants will receive Guselkumab Dose 1 subcutaneously (SC) followed by Dose 2 SC thereafter through Week 144. Participants with disease recurrence will receive guselkumab SC treatment. |
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| Group 2: Placebo | Placebo Comparator | Participants will receive matching placebo injections subcutaneously. Participants with disease recurrence will receive guselkumab SC treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Endoscopic Recurrence Prior to or at Week 48 | Endoscopic recurrence was defined by modified Rutgeerts score greater than or equal to (>=) i2a in neo-terminal ileum, anastomotic site, or its equivalent in gastrointestinal (GI) tract (e.g., colonic ulceration). The modified Rutgeerts score ranged from i0 to i4, where i0 (No lesions), i1 (less than [<] 5 aphthous lesions), i2 (greater than [>] 5 aphthous lesions with normal mucosa between lesions or skip areas of larger lesions or lesions confined to ileocolonic anastomosis [<1 centimeter (cm) in length]), i2a (lesions confined to ileocolonic anastomosis [including anastomotic stenosis]), i2b (more than 5 aphthous ulcers or larger lesions, with normal mucosa in-between, in the neoterminal ileum [with or without anastomotic lesions]), i3 (diffuse aphthous ileitis with diffusely inflamed mucosa), i4 (large ulcers with diffuse mucosal inflammation or nodules or stenosis in neoterminal ileum). Higher score indicated worsening. | Baseline (Day 1) up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission Without Disease Recurrence at Week 48 | Clinical remission without disease recurrence at Week 48 was a composite endpoint defined by (1) Crohn's disease activity index (CDAI) <150 at Week 48 & (2) no endoscopic recurrence as defined by modified Rutgeerts score < i2a by Week 48 & (3) have not experienced disease recurrence. Disease recurrence was defined as (1) >=70 point increase from baseline in CDAI score at >8 weeks after randomization & CDAI score >=200 and evidence of endoscopic recurrence (Rutgeerts score <i2a) or (2) initiation of physician-prescribed corticosteroids or increase in steroid dose of >5 milligrams per day (mg/day) for treatment of Crohn's disease (CD) and endoscopic recurrence or (3) new draining or reopening of an internal or external fistula or (4) new perianal abscess or (5) new intra-abdominal abscess more than 3 months post index surgery. If a patient tested positive for enteric pathogen, infection should be treated and then participant should be reassessed for whether they meet disease recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States | ||
| Gastroenterology Group Of Naples |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & 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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Due to early termination of the study, treatment period was up to Week 16 only. Participants were followed up for safety analysis till Week 28. The planned efficacy analysis was not performed due to the early study termination for reasons unrelated to safety or efficacy.
A total of 4 participants who had recently undergone a surgical resection for Crohn's Disease (CD) were enrolled, randomized (1:1) and treated with study drug or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Guselkumab 200 mg + Guselkumab 100 mg | Participants were assigned to receive guselkumab 200 milligrams (mg) subcutaneous (SC) injection at Week 0 followed by guselkumab 100 mg SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16). |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Dec 2, 2022 | Sep 20, 2024 |
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| Placebo | Drug | Placebo will be administered subcutaneously. |
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| At Week 48 |
| Time to Disease Recurrence | Disease recurrence was defined by (1) a >=70 point increase from baseline in CDAI score at >8 weeks after randomization & CDAI score >=200 and evidence of endoscopic recurrence (Rutgeerts score <i2a) or (2) initiation of physician-prescribed corticosteroids or increase in steroid dose of >5 milligrams per day (mg/day) for treatment of Crohn's disease (CD) and endoscopic recurrence or (3) new draining or reopening of an internal or external fistula or (4) new perianal abscess or (5) new intra-abdominal abscess more than 3 months post index surgery. If a patient tested positive for enteric pathogen, infection should be treated and then participant should be reassessed for whether they meet disease recurrence. | Baseline (Day 1) up to Week 48 |
| Percentage of Participants With No Abdominal Pain at Week 48 | Abdominal pain free at Week 48 is defined as abdominal pain (AP) score = 0 at Week 48. The scoring was done on a 4-point scale, ranged from 0 to 3, where 0 equals none, 1 equals mild, 2 equals moderate and 3 equals severe pain. Higher score indicated severe pain. | At Week 48 |
| Time To Recurrence of Symptoms | Time-to-recurrence of symptoms was defined as time to attaining an AP mean daily score >1 (and also >1 point higher than baseline) along with stool frequency (SF) mean daily score >3 (and also >3 higher per day than baseline) for 2 consecutive weeks through Week 48. AP score scaling was done on a 4-point score scale, ranged from 0 to 3, where 0 equals none, 1 equals mild, 2 equals moderate and 3 equals severe pain. Higher score indicated severe pain. Stool frequency score was calculated from the total number of liquid or very soft stools in the previous 7 days. | Baseline (Day 1) up to Week 48 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Number of participants with TEAEs and TESAEs 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. A 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/SAE occurring at or after the initial administration of study intervention through early termination of trial (up to Week 28) was considered to be treatment emergent. | Baseline (Day 1) up to early termination of trial (up to Week 28) |
| Serum Guselkumab Concentrations Over Time | Serum guselkumab concentrations over time were reported. No summary analysis was done as study was terminated early and participant wise data were reported. This outcome measure was planned to be analyzed for "Guselkumab 200 mg + Guselkumab 100 mg" arm only. | At Weeks 0, 8, 16 |
| Percentage of Participants With Steroid Free Clinical Remission at Week 48 | Steroid free clinical remission at Week 48 is defined as CDAI <150 and no corticosteroids within 30 days. The CDAI was a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicated higher disease activities. | At Week 48 |
| Naples |
| Florida |
| 34102 |
| United States |
| Gastroenterolgy Associates of Central GA | Macon | Georgia | 31201 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | United States |
| Asheville Gastroenterology Associates | Asheville | North Carolina | 28801 | United States |
| Gastro Health Ohio | Cincinnati | Ohio | 45219 | United States |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | United States |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Centrum Medyczne Medyk | Rzeszów | 35-326 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16) |
| Treated at Weeks 0, 8 and 16 |
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| Treated at Weeks 0, 8 |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on all randomized participants. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, data were reported under a single arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants received guselkumab 200 mg or matching placebo SC injection at Week 0 followed by guselkumab 100 mg or matching placebo SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16). |
| 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 | Standard Deviation | 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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| 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 | Percentage of Participants With Endoscopic Recurrence Prior to or at Week 48 | Endoscopic recurrence was defined by modified Rutgeerts score greater than or equal to (>=) i2a in neo-terminal ileum, anastomotic site, or its equivalent in gastrointestinal (GI) tract (e.g., colonic ulceration). The modified Rutgeerts score ranged from i0 to i4, where i0 (No lesions), i1 (less than [<] 5 aphthous lesions), i2 (greater than [>] 5 aphthous lesions with normal mucosa between lesions or skip areas of larger lesions or lesions confined to ileocolonic anastomosis [<1 centimeter (cm) in length]), i2a (lesions confined to ileocolonic anastomosis [including anastomotic stenosis]), i2b (more than 5 aphthous ulcers or larger lesions, with normal mucosa in-between, in the neoterminal ileum [with or without anastomotic lesions]), i3 (diffuse aphthous ileitis with diffusely inflamed mucosa), i4 (large ulcers with diffuse mucosal inflammation or nodules or stenosis in neoterminal ileum). Higher score indicated worsening. | As no participant was available for the analysis due to early termination of study, no data was collected for this outcome measure. | Posted | Baseline (Day 1) up to Week 48 |
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| Secondary | Percentage of Participants With Clinical Remission Without Disease Recurrence at Week 48 | Clinical remission without disease recurrence at Week 48 was a composite endpoint defined by (1) Crohn's disease activity index (CDAI) <150 at Week 48 & (2) no endoscopic recurrence as defined by modified Rutgeerts score < i2a by Week 48 & (3) have not experienced disease recurrence. Disease recurrence was defined as (1) >=70 point increase from baseline in CDAI score at >8 weeks after randomization & CDAI score >=200 and evidence of endoscopic recurrence (Rutgeerts score <i2a) or (2) initiation of physician-prescribed corticosteroids or increase in steroid dose of >5 milligrams per day (mg/day) for treatment of Crohn's disease (CD) and endoscopic recurrence or (3) new draining or reopening of an internal or external fistula or (4) new perianal abscess or (5) new intra-abdominal abscess more than 3 months post index surgery. If a patient tested positive for enteric pathogen, infection should be treated and then participant should be reassessed for whether they meet disease recurrence. | Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure. | Posted | At Week 48 |
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| Secondary | Time to Disease Recurrence | Disease recurrence was defined by (1) a >=70 point increase from baseline in CDAI score at >8 weeks after randomization & CDAI score >=200 and evidence of endoscopic recurrence (Rutgeerts score <i2a) or (2) initiation of physician-prescribed corticosteroids or increase in steroid dose of >5 milligrams per day (mg/day) for treatment of Crohn's disease (CD) and endoscopic recurrence or (3) new draining or reopening of an internal or external fistula or (4) new perianal abscess or (5) new intra-abdominal abscess more than 3 months post index surgery. If a patient tested positive for enteric pathogen, infection should be treated and then participant should be reassessed for whether they meet disease recurrence. | Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure. | Posted | Baseline (Day 1) up to Week 48 |
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| Secondary | Percentage of Participants With No Abdominal Pain at Week 48 | Abdominal pain free at Week 48 is defined as abdominal pain (AP) score = 0 at Week 48. The scoring was done on a 4-point scale, ranged from 0 to 3, where 0 equals none, 1 equals mild, 2 equals moderate and 3 equals severe pain. Higher score indicated severe pain. | Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure. | Posted | At Week 48 |
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| Secondary | Time To Recurrence of Symptoms | Time-to-recurrence of symptoms was defined as time to attaining an AP mean daily score >1 (and also >1 point higher than baseline) along with stool frequency (SF) mean daily score >3 (and also >3 higher per day than baseline) for 2 consecutive weeks through Week 48. AP score scaling was done on a 4-point score scale, ranged from 0 to 3, where 0 equals none, 1 equals mild, 2 equals moderate and 3 equals severe pain. Higher score indicated severe pain. Stool frequency score was calculated from the total number of liquid or very soft stools in the previous 7 days. | Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure. | Posted | Baseline (Day 1) up to Week 48 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Number of participants with TEAEs and TESAEs 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. A 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/SAE occurring at or after the initial administration of study intervention through early termination of trial (up to Week 28) was considered to be treatment emergent. | Safety analysis set included all randomized participants who received at least 1 dose of study intervention and were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Baseline (Day 1) up to early termination of trial (up to Week 28) |
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| Secondary | Serum Guselkumab Concentrations Over Time | Serum guselkumab concentrations over time were reported. No summary analysis was done as study was terminated early and participant wise data were reported. This outcome measure was planned to be analyzed for "Guselkumab 200 mg + Guselkumab 100 mg" arm only. | Pharmacokinetic (PK) analysis set included all randomized participants who received at least 1 dose of study intervention, and had at least 1 valid blood sample drawn postbaseline for PK analysis and were analyzed according to the study intervention received. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies number of participants analyzed at specified categories. | Posted | Number | micrograms/milliliters (ug/mL) | At Weeks 0, 8, 16 |
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| Secondary | Percentage of Participants With Steroid Free Clinical Remission at Week 48 | Steroid free clinical remission at Week 48 is defined as CDAI <150 and no corticosteroids within 30 days. The CDAI was a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicated higher disease activities. | Due to early termination of the study, no formal data collection and analysis was possible and thus no data was collected for this outcome measure. | Posted | At Week 48 |
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Baseline (Day 1) up to 12 weeks after last study dose administration (up to Week 28)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention and were analyzed according to the study intervention they actually received.
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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 200 mg + Guselkumab 100 mg | Participants were assigned to receive guselkumab 200 milligrams (mg) subcutaneous (SC) injection at Week 0 followed by guselkumab 100 mg SC injection at every 8 weeks thereafter until study termination (i.e., up to Week 16). | 0 | 2 | 1 | 2 | 0 | 2 |
| EG001 | Placebo | Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16) | 0 | 2 | 1 | 2 | 0 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Campylobacter Gastroenteritis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
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Due to early termination of study, protocol planned primary endpoint and few of secondary endpoints were not evaluable. Termination was not related to safety or efficacy of guselkumab.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director Gastroenterology | Janssen Pharmaceuticals, Inc, US Medical Affairs | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2023 | Sep 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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| Adults (18-64 years) |
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| From 65 to 84 years |
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| 85 years and over |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16) |
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| Units | Counts |
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| Participants |
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Participants were assigned to receive placebo matched to guselkumab SC injections at week 0 and at every 8 weeks thereafter until study termination (i.e., up to Week 16)
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