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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002629-51 | EudraCT Number | ||
| CNTO1275CRD3008 | Other Identifier | Janssen-Cilag Ltd. |
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The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
This study compares the efficacy and safety of a single weight-tiered based IV re-induction dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg ustekinumab administration. It consists of screening (5 weeks); treatment period (Week 0 to 24); and safety follow up visit (20 weeks after last dose). The primary hypothesis is that a single IV re-induction dose of ustekinumab is superior to continuing with regular SC q8w maintenance treatment as measured by clinical response after 16 weeks of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy, patient-reported outcomes (PROs), laboratory evaluations, biomarkers, review of concomitant medications and adverse events (AEs), and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will be randomly assigned to receive either ustekinumab IV re-induction or regular SC q8w 90 mg ustekinumab injection at baseline in a double dummy design. No participants will be treated with placebo only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Ustekinumab (IV re-induction) | Experimental | Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician. |
|
| Group 2: Ustekinumab (Continuous q8w SC maintenance) | Active Comparator | Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab approximately 6 mg/kg (IV) | Drug | Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response at Week 16 | Clinical response was defined as greater than or equal to (>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score < 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-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 participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission at Week 16 | Percentage of participants with clinical remission at Week 16 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-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 participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. |
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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 |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States | ||
| Peak Gastroenterology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40971924 | Derived | Schreiber S, Lee SD, van der Woude CJ, Marin-Jimenez I, Wolf DC, Schnoy E, Salzberg B, Busse C, Nazar M, Ma T, Borghorst S, Gasink C, Baker T, Godwin B, Adedokun OJ, Feagan BG; POWER Study Group. Ustekinumab Intravenous Reinduction after Secondary Loss of Response in Patients with Crohn's Disease. Inflamm Bowel Dis. 2025 Dec 1;31(12):3286-3297. doi: 10.1093/ibd/izaf163. | |
| 40357993 |
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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 and Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Ustekinumab (IV Re-induction) | Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
| 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 | Aug 5, 2020 | Aug 16, 2023 |
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| Placebo (SC) | Drug | Participants will receive SC injection of placebo at Week 0. |
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| Placebo (IV) | Drug | Participants will receive IV infusion of placebo at Week 0. |
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| Ustekinumab 90 mg (SC) Group 1 | Drug | Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16. |
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| Ustekinumab 90 mg (SC) Group 2 | Drug | Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16. |
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| Week 16 |
| Percentage of Participants With Clinical Response at Week 8 | Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different CD-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 indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. | Week 8 |
| Percentage of Participants With Clinical Remission at Week 8 | Percentage of participants with clinical remission at Week 8 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-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 participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. | Week 8 |
| Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16 | Percentage of participants with normalization at Week 16, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward. | Week 16 |
| Percentage of Participants With Clinical Remission at Week 24 | Percentage of participants with clinical remission at Week 24 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-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 participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. | Week 24 |
| Percentage of Participants With Clinical Response at Week 24 | Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 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 indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. | Week 24 |
| Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24 | Percentage of participants with normalization at Week 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward. | Week 24 |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported. | From baseline (Week 0) up to Week 36 |
| Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | A serious adverse event (SAE) was an adverse event 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; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. | From baseline (Week 0) up to Week 36 |
| Percentage of Participants With Treatment-emergent Infections | Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. | From baseline (Week 0) up to Week 36 |
| Percentage of Participants With Treatment-emergent Serious Infections | Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. | From baseline (Week 0) up to Week 36 |
| Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported. | Baseline, Weeks 8, 16, 24 |
| Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Change from baseline in clinical laboratory values for hematology (hematocrit) was reported. | Baseline, Weeks 8, 16, 24 |
| Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported. | Baseline, Weeks 8, 16, 24 |
| Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported. | Baseline, Weeks 8, 16, 24 |
| Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported. | Baseline, Weeks 8, 16, 24 |
| Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported. | Baseline, Weeks 8, 16, 24 |
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Advent Health | Orlando | Florida | 32803 | United States |
| Florida Hospital Tampa | Tampa | Florida | 33613 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's | Atlanta | Georgia | 30342-5020 | United States |
| Atlanta Gastroenterology Specialists | Suwanee | Georgia | 30024 | United States |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Brigham And Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39202 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Ohio State University Hospital | Hilliard | Ohio | 43026 | United States |
| Northshore Gastroenterology Research, LLC | Westlake | Ohio | 44145 | United States |
| Oklahoma Digestive Disease Specialists | Oklahoma City | Oklahoma | 73112 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Texas Digestive Disease Consultants | Cedar Park | Texas | 78613 | United States |
| Baylor College of Medicine | Houston | Texas | 77025 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030-2740 | United States |
| Gastroenterology Research of America, LLC | San Antonio | Texas | 78229 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Washington Gastroenterology, PLLC | Tacoma | Washington | 98405 | United States |
| Krankenhaus der Barmherzigen Brüder | Vienna | 1020 | Austria |
| Medizinische Universitaet Wien | Vienna | 1090 | Austria |
| Hepato-gastroenterologie HK, s.r.o. | Hradec Králové | 500 12 | Czechia |
| ISCARE a.s. | Prague | 190 00 | Czechia |
| Hopital Beaujon | Clichy | 92110 | France |
| CHRU de Lille Hopital Claude Huriez | Lille | 59037 | France |
| CHRU Montpellier - Hopital Saint-Eloi | Montpellier | 34295 | France |
| CHU Hopital Saint Antoine | Paris | 75571 | France |
| Hospices Civils de Lyon HCL | Pierre-Bénite | 69495 | France |
| CHRU Hopital de Pontchaillou | Rennes | 35033 | France |
| CHU de Nancy_ Hopital Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Klinikum Augsburg | Augsburg | D-86158 | Germany |
| GASTRO-Studien | Berlin | 10825 | Germany |
| Charite - Universitaetsmedizin Berlin (CCM) | Berlin | 12203 | Germany |
| Medizinisches Versorgungszentrum (MVZ) Dachau | Dachau | 85221 | Germany |
| University Hospital Dresden | Dresden | 1307 | Germany |
| Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus | Frankfurt | 60431 | Germany |
| Universitatsklinikum Frankfurt/ Medizinische Klinik 1 | Frankfurt | 60590 | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH | Halle | 06120 | Germany |
| Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K. | Hamburg | 20251 | Germany |
| Gastroenterologie Opernstrasse | Kassel | 34117 | Germany |
| Universitatsklinikum Schleswig Holstein Kiel | Kiel | 24105 | Germany |
| Staedtisches Klinikum Lueneburg | Lüneburg | 21339 | Germany |
| Universitätsklinikum Otto-von-Guericke-Universität Magdeburg | Magdeburg | 39120 | Germany |
| Medizinische Fakultät Mannheim der Universität Heidelberg | Mannheim | 68167 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| Klinikum der Universitaet Muenchen | München | 81377 | Germany |
| Praxis Dr. med. Ulf Helwig | Oldenburg | 26123 | Germany |
| Zentrum für Gastroenterologie Saar MVZ GmbH | Saarbrücken | 66111 | Germany |
| Universitaetsklinik Tuebingen | Tübingen | 72076 | Germany |
| Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II | Ulm | 89081 | Germany |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Ospedale Villa Sofia-Cervello | Palermo | 90146 | Italy |
| Azienda Ospedaliera G.Salvini Ospedale di Rho | Rho | Italy |
| Fondazione Policlinico Gemelli Università Cattolica | Roma | 168 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| AO Ordine Mauriziano | Torino | 10128 | Italy |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 AC | Netherlands |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Maastricht Universitair Medisch Centrum | Maastricht | 6229 HX | Netherlands |
| Radboudumc | Nijmegen | 6525 GA | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| Sint Franciscus Gasthuis | Rotterdam | 3045 PM | Netherlands |
| Irkutsk State Medical Academy of Postgraduate Education | Irkutsk | 664079 | Russia |
| Olla-Med, Llc | Moscow | 105554 | Russia |
| City Clinical Hospital #31 | Saint Petersburg | 197110 | Russia |
| GBUZ Respublican Clinical Hospital n.a. GG Kuvatova | Ufa | 450005 | Russia |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| KyungHee University Hospital | Seoul | 102-1703 | South Korea |
| Hosp. Univ. Fundacion Alcorcon | Alcorcón | 28922 | Spain |
| Hosp. Arquitecto Marcide | Ferrol | 15405 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp Virgen de La Victoria | Málaga | 29010 | Spain |
| Hosp. Univ. Virgen de La Arrixaca | Murcia | 30120 | Spain |
| Hosp. de Navarra | Pamplona | 31008 | Spain |
| Hosp. Montecelo | Pontevedra | 36071 | Spain |
| Corporacio Sanitari Parc Tauli | Sabadell | 08208 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Hosp. Clinico Univ. de Valencia | Valencia | 46010 | Spain |
| Hosp. Alvaro Cunqueiro | Vigo | 36213 | Spain |
| Hosp. Clinico Univ. Lozano Blesa | Zaragoza | 50009 | Spain |
| Hosp. Univ. Miguel Servet | Zaragoza | 50009 | Spain |
| Gastromottagningen | Malmö | 20502 | Sweden |
| Gastromottagningen | Stockholm | 18288 | Sweden |
| Pennine Acute Hospitals-Fairfield General Hospital | Bury | BL9 7TD | United Kingdom |
| Gloucestershire Hospitals NHS Foundation Trust - Cheltenham | Cheltenham | GL53 7AN | United Kingdom |
| Royal Devon & Exeter Hospital | Exeter | EX2 5DW | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| St George's Hospital | London | SW17 OQT | United Kingdom |
| Southampton University Hospitals NHS Trust | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4. |
| 34334713 | Derived | Ten Bokkel Huinink S, Biemans V, Duijvestein M, Pierik M, Hoentjen F, West RL, van der Woude CJ, de Vries AC. Re-induction with intravenous Ustekinumab after secondary loss of response is a valid optimization strategy in Crohn's disease. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e783-e788. doi: 10.1097/MEG.0000000000002256. |
| FG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Ustekinumab (IV Re-induction) | Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
| BG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
| BG002 | Total | Total of all reporting groups |
| 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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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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| Region of Enrollment | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Clinical Response at Week 16 | Clinical response was defined as greater than or equal to (>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score < 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-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 participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. | Full analysis set included all randomized participants. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Clinical Remission at Week 16 | Percentage of participants with clinical remission at Week 16 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-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 participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. | Full analysis set included all randomized participants. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Clinical Response at Week 8 | Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different CD-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 indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. | Full analysis set included all randomized participants. | Posted | Number | Percentage of participants | Week 8 |
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| Secondary | Percentage of Participants With Clinical Remission at Week 8 | Percentage of participants with clinical remission at Week 8 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-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 participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. | Full analysis set included all randomized participants. | Posted | Number | Percentage of participants | Week 8 |
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| Secondary | Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16 | Percentage of participants with normalization at Week 16, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward. | Full analysis set included all randomized participants with either elevated CRP and/or elevated fCal at baseline. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Clinical Remission at Week 24 | Percentage of participants with clinical remission at Week 24 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-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 participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. | Full analysis set included all randomized participants. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Clinical Response at Week 24 | Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 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 indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. | Full analysis set included all randomized participants. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24 | Percentage of participants with normalization at Week 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward. | Full analysis set included all randomized participants with either elevated CRP and/or elevated fCal at baseline. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. | Posted | Number | Percentage of participants | From baseline (Week 0) up to Week 36 |
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| Secondary | Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | A serious adverse event (SAE) was an adverse event 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; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. | Posted | Number | Percentage of participants | From baseline (Week 0) up to Week 36 |
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| Secondary | Percentage of Participants With Treatment-emergent Infections | Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. | Posted | Number | Percentage of participants | From baseline (Week 0) up to Week 36 |
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| Secondary | Percentage of Participants With Treatment-emergent Serious Infections | Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. | Posted | Number | Percentage of participants | From baseline (Week 0) up to Week 36 |
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| Secondary | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters. | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline, Weeks 8, 16, 24 |
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| Secondary | Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Change from baseline in clinical laboratory values for hematology (hematocrit) was reported. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints. | Posted | Mean | Standard Deviation | Percentage of red blood cells | Baseline, Weeks 8, 16, 24 |
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| Secondary | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specific parameters. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Weeks 8, 16, 24 |
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| Secondary | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters. | Posted | Mean | Standard Deviation | Units per Liter (U/L) | Baseline, Weeks 8, 16, 24 |
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| Secondary | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters. | Posted | Mean | Standard Deviation | micromole per liter (mcmol/L) | Baseline, Weeks 8, 16, 24 |
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| Secondary | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported. | Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Baseline, Weeks 8, 16, 24 |
|
From baseline (Week 0) up to Week 36
Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Ustekinumab (IV Re-induction) | Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. | 1 | 108 | 9 | 108 | 73 | 108 |
| EG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. | 0 | 107 | 13 | 107 | 77 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Ileal Stenosis | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Small Intestinal Stenosis | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Renal Atrophy | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Urethral Stenosis | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Eye Irritation | Eye disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Mass | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abdominal Tenderness | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Anal Eczema | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Anal Skin Tags | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Eosinophilic Oesophagitis | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal Inflammation | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Injection Site Mass | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Abscess Soft Tissue | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Coronavirus Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Enteritis Infectious | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Erythema Migrans | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Infected Fistula | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pyelitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Ureaplasma Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Injection Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Vaccination Complication | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Blood Magnesium Decreased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Sars-Cov-2 Test Positive | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Vitamin D Decreased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Zinc Deficiency | Metabolism and nutrition disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Greater Trochanteric Pain Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Muscle Contracture | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Rheumatic Disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pituitary Tumour Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Carotid Arteriosclerosis | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Ophthalmic Migraine | Nervous system disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Affective Disorder | Psychiatric disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Conversion Disorder | Psychiatric disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pelvi-Ureteric Obstruction | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Heavy Menstrual Bleeding | Reproductive system and breast disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pelvic Fluid Collection | Reproductive system and breast disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Scrotal Dermatitis | Reproductive system and breast disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Tonsillar Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Erythema Nodosum | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.1 | Non-systematic Assessment |
| |
| Superficial Vein Thrombosis | Vascular disorders | MedDRA Version 23.1 | Non-systematic Assessment |
|
Some exploratory endpoints including endoscopic assessments for baseline and Week 16, and clinical data for 24 weeks are not reported in this summary and will be included in the manuscript.
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 with hold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director GI Clinical Development | Janssen-Cilag Ltd. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2022 | Aug 16, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| France |
|
| Germany |
|
| Italy |
|
| Netherlands |
|
| Republic of Korea |
|
| Russia |
|
| Spain |
|
| Sweden |
|
| United Kingdom |
|
| United States of America |
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
| OG001 | Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
|
|
|
|
Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
|
|
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) |
Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) |
Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. |
|
|