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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959CRD3005 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-000491-10 | EudraCT Number | ||
| 2023-504740-33-00 | Registry Identifier | EUCT number |
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The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Guselkumab | Experimental | Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab. |
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| Group 2: Guselkumab | Experimental | Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
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| Group 3: Placebo | Experimental | Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered subcutaneously/IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve Combined Fistula Remission at Week 24 | Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings [occurring spontaneously or after gentle finger compression] and absence of collections greater than (>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging [MRI] results. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve Combined Fistula Remission at Week 48 | Percentage of participants who achieve combined fistula remission at Week 48 will be reported. | Week 48 |
| Percentage of Participants who Achieve Clinically Assessed Fistula Remission |
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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 Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Yale University |
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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| Placebo | Drug | Matching placebo will be administered subcutaneously/IV infusion. |
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Percentage of participants who achieve clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. |
| Week 24 |
| Percentage of Participants who Achieve Radiological Fistula Remission Based on Radiological Findings Assessed by MRI | Percentage of participants who achieve radiological fistula remission based on radiological findings assessed by MRI will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results. | Week 24 |
| Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24 | Percentage of participants who achieve clinically assessed fistula response at Week 24 will be reported. Clinically assessed fistula response is defined as a greater than or equal to (>=) 50% reduction from baseline in number of open or draining perianal fistulas. | Week 24 |
| Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12 | Percentage of participants who achieve clinically assessed fistula response at Week 12 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. | Week 12 |
| Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48 | Change from baseline in CDAI by visit over time will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis. | Baseline up to Week 48 |
| Percentage of Participants who Achieve Clinical Remission (CDAI less than [<] 150) by Visit Over Time Through Week 48 Among Participants with CDAI Greater than (>) 150 at Baseline | Percentage of participants who achieve clinical remission (CDAI <150) by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain [AP]/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis. | Through Week 48 |
| Percentage of Participants who Achieve a Clinical Response by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline | Percentage of participants who achieve a clinical response by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. Clinical response is defined greater than or equal to (>=) 100-point reduction from baseline in CDAI, or CDAI <150. | Through Week 48 |
| Percentage of Participants who Achieve Steroid-free Clinical Remission by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline | Percentage of participants who achieve steroid-free clinical remission by visit over time through Week 48 among participants with CDAI >150 at baseline will be reported. Steroid-free clinical remission is defined as CDAI <150 and not receiving corticosteroids by visit over time through Week 48 among participants with CDAI >150 at baseline. | Through Week 48 |
| Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response Among Participants With CDAI >220 at Baseline | Percentage of participants who achieve combined clinical response and clinically assessed fistula response among participants with CDAI >220 at baseline at baseline will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. | Week 24 and Week 48 |
| Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline | Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission among participants with CDAI >220 at baseline at will be reported. Clinical remission is defined as CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. | Week 24 and Week 48 |
| Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline | Percentage of participants who achieve combined clinical response and clinically assessed fistula remission among participants with CDAI >220 at baseline will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. | Week 24 and Week 48 |
| Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response among Participants with CDAI >220 at Baseline | Percentage of participants who achieve combined clinical remission and clinically assessed fistula response among participants with CDAI >220 at baseline will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. | Week 24 and Week 48 |
| Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response at Week 24 and Week 48 | Percentage of participants who achieve combined clinical response and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. | Week 24 and Week 48 |
| Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission at Week 24 and Week 48 | Percentage of participants who achieve combined clinical response and clinically assessed fistula remission at Week 24 and Week 48 will be reported. Clinical response is defined >=100-point reduction from baseline in CDAI, or CDAI <150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. | Week 24 and Week 48 |
| Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response at Week 24 and Week 48 | Percentage of participants who achieve combined clinical remission and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. | Week 24 and Week 48 |
| Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission at Week 24 and Week 48 | Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. | Week 24 and Week 48 |
| Change from Baseline in Perianal Disease Activity Index (PDAI) Overall Score, Discharge Score, and Pain Score by Visit Over Time Through Week 48 | Change from baseline in PDAI overall score, discharge score, and pain score by visit over time through Week 48 will be reported. The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) Discharge; (0=no discharge to 4= Gross fecal soiling) (b) Pain; (0=no activity to 4= severe pain, severe limitation) (c) Restriction of sexual activity;(0=no perianal disease/skin tags to 4= unable to engage in sexual activity) (d) Type of perianal disease; (0=no perianal disease/skin tags to 4=Anal sphincter ulceration or fistulae with significant undermining ok skin) and (e) Degree of induration; (0=no induration to 4=gross fluctuance/abscess. Higher scores indicate more severe or active disease. | Baseline up to Week 48 |
| Percentage of Participants who Achieve Clinically Assessed Fistula Response by Visit Over Time Through Week 48 | Percentage of participants with clinically assessed fistula response by visit over time through Week 48 will be reported. Clinically assessed fistula response is defined as >=50% reduction from baseline in number of open or draining perianal fistulas. | Through Week 48 |
| Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48 | Percentage of participants with clinically assessed fistula remission by visit over through Week 48 time will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. | Through Week 48 |
| Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among the Participants who Achieve Clinical Fistula Remission at Week 24 | Percentage of participants who achieve clinically assessed fistula remission at Week 48 among the participants who achieve clinical fistula remission at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. | Week 48 |
| Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24 | Percentage of participants achieving clinically assessed fistula remission at Week 48 among those who achieve fistula remission or response (defined either by clinical or radiological assessment) at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. | Week 48 |
| Time to Clinical Fistula Remission | Time to clinical fistula remission will be reported. Clinical fistula remission is defined as 100% closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings (occurring spontaneously or after gentle finger compression). | Up to Week 96 |
| Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48 | Percentage of participants who achieve radiological fistula predominantly fibrotic status for all existent fistulas assessed by MRI at Week 24 and Week 48 will be reported. | Week 24 and Week 48 |
| Percentage of participants who Achieve Radiological Remission Based on Radiological Findings Assessed by MRI at Week 48 | Percentage of participants with radiological remission based on radiological findings assessed by MRI at Week 48 will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results. | Week 48 |
| Percentage of Participants who Achieve Radiological Remission Assessed by MRI at Week 48 Among the Participants who Achieve Radiological Remission at Week 24 | Percentage of participants who achieve radiological remission assessed by MRI at Week 48 among the participants who achieve radiological remission at Week 24 will be reported. Radiological remission is defined as absence of collections >2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results. | Week 48 |
| Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants who Achieve Combined Clinical and Radiological Fistula Remission at Week 24 | Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve combined clinical and radiological fistula remission at Week 24. | Week 48 |
| Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants with Clinical Fistula Response at Week 24 | Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve clinical fistula response at Week 24 will be reported. | Week 48 |
| Percentage of Participants with Proctitis at Week 48 Among Participants with MRI-confirmed Proctitis at Baseline | Percentage of participants with proctitis at Week 48 among participants with MRI-confirmed proctitis at baseline will be reported. Proctitis is defined as the inflammation of the lining of the rectum. | Week 48 |
| Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn's disease (MAGNIFI-CD) by Visit Over Time Through Week 48 | Change from baseline in MAGNIFI-CD by visit over time through Week 48 will be reported. The MAGNIFI-CD is based on MRI assessment of 6 items including number of fistula tracts, fistula length, hyperintensity of primary tract on post-contrast T1-weighted images, dominant feature, extension, and inflammatory mass. The total MAGNIFI-CD score ranges from 0 (no disease activity) to 25 (severe disease activity). It assesses the MRI data and determines perianal fistulizing CD activity with improved operating characteristics compared to the Van Assche Index (VAI) and the modified VAI (mVAI). | Baseline up to Week 48 |
| Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48 | Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by visit over time through Week 48 will be reported. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate patient reported outcomes (PROs) across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes. | Baseline up to Week 48 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48 | Change From baseline in FACIT-F Score at Week 48 will be reported. The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists of 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. | Baseline; Up to Week 48 |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48 | Change from baseline in WPAI:CD by visit over time through Week 48 will be reported. The WPAI:CD assesses the impact of CD on work and activity during the past 7 days. The specificity of WPAI:CD is achieved by replacing "health problems" in the general health version of the WPAI with "CD." It consists of 6 questions, which elicit the following information: employment status; hours missed due to CD; hours missed due to other reasons; hours actually worked; the degree to which CD affected productivity while working from 0 (no effect) to 10 (maximum impairment); and the degree to which CD affected regular activities (from 0-10). The sum of worktime missed and impairment at work yields the overall work impairment (productivity loss) score; scores are expressed as percent of impairment/productivity loss, with higher scores indicating greater impairment. | Baseline; Up to Week 48 |
| Change from Baseline in Quality-of-life as Assessed by European Quality-of-Life Five Dimension Five Level Scale (EQ5D-5L) Score by Visit Over Time Through Week 48 | Change from baseline in quality-of-life (EQ5D-5L) score by visit over time through Week 48 will be reported. The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline up to Week 48 |
| Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48 | Change from baseline in the Jorge-Wexner score by visit over time through Week 48 will be reported. The Jorge-Wexner scoring system cross-tabulates frequencies and different anal incontinence presentations. | Baseline; Through Week 48 |
| Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48 | Change from baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by visit over time through Week 48 will be reported. The IBD-DI consists of 28 items that evaluate the 5 domains of overall health, body function, body structures, activity participation and environmental factors. Each item response is graded from 0 to 4 for each area evaluated (0 = very good; 1 = Good; 2 = medium; 3 = Bad; 4 = Very bad). The final composite score representative of the overall degree of disability ranging from -80 (maximum degree of disability) to 22 (no disability). | Baseline; Through Week 48 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Week 48 and Week 96 |
| Number of Participants with Treatment-emergent Serious Adverse Events (TESAEs) | An serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TESAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state. | Up to Week 48 and Week 96 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Gastroenterology Group Of Naples | Naples | Florida | 34102 | United States |
| AdventHealth Medical Group Blood & Marrow Transplant at Orlando | Orlando | Florida | 32804 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | 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 |
| Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | 73112 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Flinders Medical Centre | Adelaide | 5042 | Australia |
| St Vincent's Hospital - Melbourne | Fitzroy | 3065 | Australia |
| Liverpool Hospital | Liverpool | 2170 | Australia |
| Fiona Stanley Hospital | Murdoch | 6150 | Australia |
| Royal Prince Alfred Hospital | Newtown | 2042 | Australia |
| Royal Adelaide Hospital | North Terrace | 5000 | Australia |
| Royal Melbourne Hospital | Parkville | 3050 | Australia |
| Royal Perth Hospital | Perth | 6000 | Australia |
| Mater Hospital | South Brisbane | 4101 | Australia |
| Hopital Erasme | Brussels | 1070 | Belgium |
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU Sart Tilman | Liège | B-4000 | Belgium |
| University of Alberta- Ziedler Ledcor Centre | Edmonton | Alberta | T6G 2X8 | Canada |
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H2Y9 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada |
| Nemocnice Ceske Budejovice a s | České Budějovice | 37001 | Czechia |
| ISCARE a.s. | Prague | 190 00 | Czechia |
| Alexandria University Hospital 1 | Alexandria | 21131 | Egypt |
| Alexandria University Hospital | Alexandria | 21131 | Egypt |
| National Hepatology and Tropical Medicine Research Institute | Cairo | 11451 | Egypt |
| Ain Shams University Hospital | Cairo | 11517 | Egypt |
| Cairo university | Giza | 12613 | Egypt |
| Clinique Ambroise Pare | Neuilly-sur-Seine | 92200 | France |
| CHU de Nice Hopital de l Archet | Nice | 06202 | France |
| Hopital Saint Joseph | Paris | 75014 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CHRU Hopital de Pontchaillou | Rennes | 35033 | France |
| CHRU Nancy Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Charite - Campus Mitte | Berlin | 10117 | Germany |
| JWG-University Hospital | Frankfurt | 60590 | Germany |
| Universitatsklinikum Schleswig Holstein Kiel | Kiel | 24105 | Germany |
| Universitaetsklinikum Mannheim | Mannheim | 68167 | Germany |
| Universitaetsklinikum Ulm | Ulm | 89081 | Germany |
| Evangelismos General Hospital of Athens | Athens | 10676 | Greece |
| Hippokration Hospital 1 | Athens | 11528 | Greece |
| Sotiria General State Hospital of Chest Diseases | Athens | 156 69 | Greece |
| Alexandra General Hospital of Athens | Athens Attica | 115 28 | Greece |
| University Hospital of Heraklion | Heraklion | 71110 | Greece |
| University Hospital Of Larissa | Larissa | 41110 | Greece |
| Patras University Hospital | Pátrai | 26504 | Greece |
| Hippokration Hospital | Thessaloniki | 54642 | Greece |
| Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | 1062 | Hungary |
| Semmelweis Egyetem | Budapest | 1082 | Hungary |
| Semmelweis Egyetem 2 | Budapest | 1083 | Hungary |
| Semmelweis Egyetem 1 | Budapest | H-1088 | Hungary |
| Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika | Pécs | 7624 | Hungary |
| Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp | Szeged | 6725 | Hungary |
| Haemek Medical Center | Afula | 1834111 | Israel |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Rabin Medical Center Beilinson Campus | Petah Tikva | 4941492 | Israel |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar | Negrar ( Ve) | 37024 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | 56124 | Italy |
| Azienda Ospedaliera G.Salvini Ospedale di Rho | Rho | Italy |
| Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Casa Sollievo della Sofferenza | San Giovanni Rotondo | 71013 | Italy |
| KOKIKAI Tokatsu Tsujinaka Hospital | Abiko | 270-1168 | Japan |
| Fukuoka University Chikushi Hospital | Chikushino-shi | 818-8502 | Japan |
| Hospital of the University of Occupational and Environmental Health | Fukuoka | 807-8555 | Japan |
| Fukuoka University Hospital | Fukuoka | 814 0180 | Japan |
| Kitakyushu Municipal Medical Center | Fukuoka-ken | 802-0077 | Japan |
| Hiroshima University Hospital | Hiroshima | 734 8551 | Japan |
| Sameshima Hospital | Kagoshima | 892-0846 | Japan |
| Nara Medical University Hospital | Kashihara | 634-8521 | Japan |
| Tsujinaka Hospital Kashiwanoha | Kashiwa | 277-0871 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| Kojunkai Daido Clinic | Nagoya | 457-8511 | Japan |
| Nagoya University Hospital | Nagoya | 466 8560 | Japan |
| The Hospital of Hyogo College of Medicine | Nishinomiya | 663-8501 | Japan |
| Okayama University Hospital | Okayama | 700 8558 | Japan |
| Kinshukai Infusion Clinic | Osaka | 530-0011 | Japan |
| JOHAS Osaka Rosai Hospital | Sakai | 591-8025 | Japan |
| Sapporo Higashi Tokushukai Hospital | Sapporo | 065-0033 | Japan |
| Tokyo Yamate Medical Center | Shinjuku-ku | 169-0073 | Japan |
| Matsuda Hospital | Shizuoka | 432-8061 | Japan |
| Osaka University Hospital | Suita | 565 0871 | Japan |
| Kyorin University Hospital | Tokyo | 181 8611 | Japan |
| Ieda Hospital | Toyota | 470-1219 | Japan |
| Mie University Hospital | Tsu | 514 8507 | Japan |
| Yokkaichi Hazu Medical Center | Yokkaichi | 510-0016 | Japan |
| Yokohama Municipal Citizen's Hospital | Yokohama | 221 0855 | Japan |
| The Speciality Hospital (TSH) / Advanced Clinical Center | Amman | 11194 | Jordan |
| Jordan University Hospital | Amman | 11942 | Jordan |
| Abdali Hospital | Amman | Jordan |
| Irbid Specialty Hospital | Irbid | 21110 | Jordan |
| King Abdullah University Hospital | Irbid | 22110 | Jordan |
| Academisch Medisch Centrum Universiteit van Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| Radboudumc | Nijmegen | 6525 GA | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
| Gastromed Kralisz Romatowski Stachurska Sp. j. | Bialystok | 15-322 | Poland |
| Centrum Medyczne Promed | Krakow | 31-513 | Poland |
| Centrum Medyczne Med Gastr | Lodz | 91 034 | Poland |
| Centrum Medyczne Medyk | Rzeszów | 35-326 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii | Torun | 87 100 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
| Melita Medical Sp. z o.o. | Wroclaw | 50-449 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52-416 | Poland |
| Uls Braga - Hosp. Braga | Braga | 4710-243 | Portugal |
| Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos | Lisbon | G1R 2J6 | Portugal |
| H. Santo António - Centro Hospitalar do Porto | Porto | 4099-001 | Portugal |
| King Fahad Specialist hospital | Dammam | 31444 | Saudi Arabia |
| King Abdulaziz Medical City | Jeddah | 21423 | Saudi Arabia |
| King Saud University Medical City | Riyadh | 11472 | Saudi Arabia |
| King Faisal Specialist Hospital & Research Center | Riyadh | 12713 | Saudi Arabia |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Yeungnam University Hospital | Daegu | 42415 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 06273 | South Korea |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Arquitecto Marcide | Ferrol | 15405 | Spain |
| Hosp. Univ. Dr. Josep Trueta | Girona | 17007 | Spain |
| Hosp. Univ. de La Princesa | Madrid | 28006 | Spain |
| Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | 28222 | Spain |
| Hosp. Virgen Macarena | Seville | 41009 | Spain |
| Hosp. Alvaro Cunqueiro | Vigo | 36312 | Spain |
| Hosp. Univ. Miguel Servet | Zaragoza | 50009 | Spain |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Chang Gung Memorial Hospital Linkou Branch | Taoyuan City | 333 | Taiwan |
| Gazi University Medical Faculty | Ankara | 06560 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Acibadem Kozyatagi Hospital | Istanbul | 34734 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Mersin University Medical Faculty Hospital | Mersin | 33110 | Turkey (Türkiye) |
| Hull University Teaching Hospitals NHS Trust | Hull | HU3 2JZ | United Kingdom |
| London North West University Healthcare NHS Trust | London | HA1 3UJ | United Kingdom |
| Guys and St Thomas NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| St Georges University Hospital NHS Foundation Trust | London | SW17 0QT | United Kingdom |
| Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE3 3HD | United Kingdom |
| Pennine Acute Hospitals NHS Trust | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| C000588857 | guselkumab |
Not provided
Not provided
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