FUZION CD: A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Crohn's disease is a chronic, progressive, and potentially life-threatening disorder which may affect any part of the gastrointestinal tract. Guselkumab is a fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity, without blocking IL-12. The aim is to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies. This study consists of 3 phases: 6 weeks screening phase, 48 weeks treatment phase, and a 16 weeks follow-up phase. The study will have long term extension (LTE) period for participants who complete the 48-week treatment period and in the opinion of the investigator, will continue to benefit from the study intervention. Comprehensive safety data will be collected and the total duration of the study for participants will be up to 118 weeks (including the LTE period).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: Guselkumab 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. |
Drug: Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.
Other Names:
Drug: Placebo
Matching placebo will be administered subcutaneously/IV infusion.
|
| Experimental: Group 2: Guselkumab Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 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. |
Drug: Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.
Other Names:
Drug: Placebo
Matching placebo will be administered subcutaneously/IV infusion.
|
| Experimental: Group 3: Placebo 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. |
Drug: Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.
Other Names:
Drug: Placebo
Matching placebo will be administered subcutaneously/IV infusion.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants who Achieve Combined Fistula Remission at Week 24 [Week 24]
Percentage of participants who achieve combined fistula remission at Week 24 will be reported.
Secondary Outcome Measures
- Percentage of Participants who Achieve Combined Fistula Remission at Week 48 [Week 48]
Percentage of participants who achieve combined fistula remission at Week 48 will be reported.
- Percentage of Participants who Achieve Clinically Assessed Fistula Remission [Week 24]
Percentage of participants who achieve clinically assessed fistula remission will be reported.
- Percentage of Participants who Achieve Radiological Fistula Remission Based on Radiological Findings Assessed by MRI [Week 24]
Percentage of participants who achieve radiological fistula remission based on radiological findings assessed by MRI will be reported.
- Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24 [Week 24]
Percentage of participants who achieve clinically assessed fistula response at Week 24 will be reported. Clinically assessed fistula response is defined as closure of at least 50 percent (%) of all external openings that were draining at baseline.
- Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12 [Week 12]
Percentage of participants who achieve clinically assessed fistula response at Week 12 will be reported. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline.
- Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48 [Baseline up to 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.
- 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 [Through Week 48]
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.
- Percentage of Participants who Achieve a Clinical Response by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline [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 will be reported. Clinical response is defined greater than or equal to (>=) 100-point reduction from baseline in CDAI, or CDAI <150.
- Percentage of Participants who Achieve Steroid-free Clinical Remission by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline [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 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.
- Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response Among Participants With CDAI >220 at Baseline [Week 24 and Week 48]
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 closure of at least 50% of all external openings that were draining at baseline.
- Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline [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 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.
- Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline [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 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.
- Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response among Participants with CDAI >220 at Baseline [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 will be reported. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline.
- Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response at Week 24 and Week 48 [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 closure of at least 50% of all external openings that were draining at baseline.
- Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission at Week 24 and Week 48 [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.
- Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response at Week 24 and Week 48 [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 closure of at least 50% of all external openings that were draining at baseline.
- Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission at Week 24 and Week 48 [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.
- Change from Baseline in Perianal Disease Activity Index (PDAI) Overall Score, Discharge Score, and Pain Score by Visit Over Time Through Week 48 [Baseline up to 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.
- Percentage of Participants who Achieve Clinically Assessed Fistula Response by Visit Over Time Through Week 48 [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 closure of at least 50% of all external openings that were draining at baseline.
- Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48 [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.
- Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among the Participants who Achieve Clinical Fistula Remission at Week 24 [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 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.
- Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24 [Week 48]
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.
- Time to Clinical Fistula Remission [Up to Week 96]
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).
- Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48 [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.
- Percentage of participants who Achieve Radiological Remission Based on Radiological Findings Assessed by MRI at Week 48 [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.
- Percentage of Participants who Achieve Radiological Remission Assessed by MRI at Week 48 Among the Participants who Achieve Radiological Remission at Week 24 [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 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.
- 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 [Week 48]
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.
- Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission as Week 48 Among the Participants with Clinical Fistula Response at Week 24 [Week 48]
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.
- Percentage of Participants with Proctitis at Week 48 Among Participants with MRI-confirmed Proctitis at Baseline [Week 48]
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.
- Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn's disease (MAGNIFI-CD) by Visit Over Time Through Week 48 [Baseline up to 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).
- Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48 [Baseline up to 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.
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48 [Baseline; Up to 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.
- Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48 [Baseline; Up to 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.
- 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 [Baseline up to 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).
- Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48 [Baseline; 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.
- Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48 [Baseline; 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
-
Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
-
Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD)
Exclusion Criteria:
-
Has a very severe luminal disease activity
-
History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease
-
Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
-
Any medical contraindications preventing study participation
-
Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Yale University | New Haven | Connecticut | United States | 06510 |
| 3 | University of Miami | Miami | Florida | United States | 33136 |
| 4 | Gastroenterology Group Of Naples | Naples | Florida | United States | 34102 |
| 5 | Advent Health | Orlando | Florida | United States | 32803 |
| 6 | Morehouse School of Medicine | Atlanta | Georgia | United States | 30310 |
| 7 | Atlanta Gastroenterology Associates | Atlanta | Georgia | United States | 30342 |
| 8 | Gastroenterology Consultants | Roswell | Georgia | United States | 30076 |
| 9 | University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536 |
| 10 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 11 | Brigham & Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 12 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 13 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 14 | The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 15 | Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | United States | 73112 |
| 16 | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 17 | Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | United States | 15212-4756 |
| 18 | Gastro One | Germantown | Tennessee | United States | 38138 |
| 19 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
| 20 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
| 21 | Gastroenterology Research of San Antonio | San Antonio | Texas | United States | 78229 |
| 22 | Texas Digestive Disease Consultants | Southlake | Texas | United States | 76092 |
| 23 | University of Washington | Seattle | Washington | United States | 98195 |
| 24 | Flinders Medical Centre | Adelaide | Australia | 5042 | |
| 25 | St Vincent's Hospital - Melbourne | Fitzroy | Australia | 3065 | |
| 26 | Liverpool Hospital | Liverpool | Australia | 2170 | |
| 27 | Fiona Stanley Hospital | Murdoch | Australia | 6150 | |
| 28 | Royal Prince Alfred Hospital | Newtown | Australia | 2042 | |
| 29 | Royal Adelaide Hospital | North Terrace | Australia | 5000 | |
| 30 | Royal Melbourne Hospital | Parkville | Australia | 3050 | |
| 31 | Royal Perth Hospital | Perth | Australia | 6000 | |
| 32 | Mater Hospital | South Brisbane | Australia | 4101 | |
| 33 | St John of God Subiaco Hospital | Subiaco | Australia | 6008 | |
| 34 | Hopital Erasme | Bruxelles | Belgium | 1070 | |
| 35 | UZ Gent | Gent | Belgium | 9000 | |
| 36 | UZ Leuven | Leuven | Belgium | 3000 | |
| 37 | CHU Sart Tilman | Liege | Belgium | B-4000 | |
| 38 | London Health Sciences Centre | London | Ontario | Canada | N6A 5A5 |
| 39 | Mount Sinai Hospital | Toronto | Ontario | Canada | M5G 1X5 |
| 40 | Toronto Immune & Digestive Health Institute Inc. | Toronto | Ontario | Canada | M6A 3B4 |
| 41 | McGill University Health Centre | Montreal | Quebec | Canada | H3G 1A4 |
| 42 | University of Alberta- Ziedler Ledcor Centre | Edmonton | Canada | T6G 2X8 | |
| 43 | Nemocnice Ceske Budejovice, a.s. | Ceske Budejovice | Czechia | 37001 | |
| 44 | Klinicke centrum ISCARE | Praha 9 | Czechia | 190 00 | |
| 45 | Alexandria University Hospital | Alexandria | Egypt | 21131 | |
| 46 | National Hepatology and Tropical Medicine Research Institute | Cairo | Egypt | 11451 | |
| 47 | Ain Shams University Hospital | Cairo | Egypt | 11517 | |
| 48 | Cairo university | Giza | Egypt | 12613 | |
| 49 | Hôpital Beaujon | Clichy | France | 92110 | |
| 50 | CHU de Nice Hopital de l Archet | Nice | France | 06202 | |
| 51 | Centre Hospitalier Lyon Sud | Pierre-Bénite | France | 69495 | |
| 52 | CHRU Hôpital de Pontchaillou | Rennes | France | 35033 | |
| 53 | CHU Saint-Etienne - Hôpital Nord | Saint-Priest en Jarez | France | 42270 | |
| 54 | CHRU Nancy-Brabois | Vandoeuvre-les-Nancy | France | 54511 | |
| 55 | JWG-University Hospital | Frankfurt | Germany | 60590 | |
| 56 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 57 | Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd | Heidelberg | Germany | 69121 | |
| 58 | Universitatsklinikum Schleswig-Holstein - Kiel | Kiel | Germany | 24105 | |
| 59 | Evangelismos General Hospital of Athens | Athens | Greece | 10676 | |
| 60 | Hippokration Hospital | Athens | Greece | 11528 | |
| 61 | University Hospital of Heraklion | Heraklion | Greece | 71110 | |
| 62 | Patras University Hospital | Patra | Greece | 26504 | |
| 63 | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | Hungary | 1062 | |
| 64 | Semmelweis Egyetem | Budapest | Hungary | 1082 | |
| 65 | Semmelweis Egyetem | Budapest | Hungary | H-1088 | |
| 66 | Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika | Pecs | Hungary | 7624 | |
| 67 | Rambam Medical Center | Haifa | Israel | 31096 | |
| 68 | Shaare Zedek Medical Center | Jerusalem | Israel | 9103102 | |
| 69 | Rabin Medical Center, Beilinson Campus | Petah Tikva | Israel | 4941492 | |
| 70 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | Italy | 20122 | |
| 71 | Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar | Negrar ( Ve) | Italy | 37024 | |
| 72 | Azienda Ospedaliera Universitaria Pisana | Pisa | Italy | 56124 | |
| 73 | Azienda Ospedaliera G.Salvini Ospedale di Rho | RHO | Italy | ||
| 74 | Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy | 71013 | |
| 75 | KOKIKAI Tokatsu Tsujinaka Hospital | Abiko | Japan | 270-1168 | |
| 76 | Tokyo Medical and Dental University Hospital | Bunkyo-Ku | Japan | 113-8519 | |
| 77 | Fukuoka University Chikushi Hospital | Chikushino-shi | Japan | 818-8502 | |
| 78 | Kitakyushu Municipal Medical Center | Fukuoka-ken | Japan | 802-0077 | |
| 79 | Fukuoka University Hospital | Fukuoka | Japan | 814-0180 | |
| 80 | Hiroshima University Hospital | Hiroshima-shi | Japan | 734-8551 | |
| 81 | Hospital of the University of Occupational and Enviromental Health | Hukuoka | Japan | 807-8555 | |
| 82 | Sameshima Hospital | Kagoshima | Japan | 892-0846 | |
| 83 | Nara Medical University Hospital | Kashihara | Japan | 634-8521 | |
| 84 | Nagasaki University Hospital | Nagasaki | Japan | 852-8501 | |
| 85 | Kojunkai Daido Clinic | Nagoya | Japan | 457-8511 | |
| 86 | Nagoya University Hospital | Nagoya | Japan | 466-8560 | |
| 87 | The Hospital of Hyogo College of Medicine | Nishinomiya | Japan | 663-8501 | |
| 88 | Okayama University Hospital | Okayama | Japan | 700-8558 | |
| 89 | Kinshukai Infusion Clinic | Osaka | Japan | 530-0011 | |
| 90 | JOHAS Osaka Rosai Hospital | Sakai | Japan | 591-8025 | |
| 91 | Sapporo Higashi Tokushukai Hospital | Sapporo | Japan | 065-0033 | |
| 92 | Osaka University Hospital | Suita | Japan | 565-0871 | |
| 93 | Tokyo Yamate Medical Center | Tokyo | Japan | 169-0073 | |
| 94 | Ieda Hospital | Toyota | Japan | 470-1219 | |
| 95 | Mie University Hospital | Tsu | Japan | 514-8507 | |
| 96 | Yokkaichi Hazu Medical Center | Yokkaichi | Japan | 510-0016 | |
| 97 | Yokohama Municipal Citizen's Hospital | Yokohama | Japan | 221-0855 | |
| 98 | Jordan University Hospital | Amman | Jordan | 11942 | |
| 99 | Abdali Hospital | Amman | Jordan | ||
| 100 | King Abdullah University Hospital | Irbid | Jordan | ||
| 101 | Inje University Haeundae Paik Hospital | Busan | Korea, Republic of | 48108 | |
| 102 | Yeungnam University Hospital | Daegu | Korea, Republic of | 42415 | |
| 103 | Seoul National University Bundang Hospital | Gyeonggi-do | Korea, Republic of | 13620 | |
| 104 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 105 | Gangnam Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 06273 | |
| 106 | Academisch Medisch Centrum Universiteit van Amsterdam | Amsterdam | Netherlands | 1105 AZ | |
| 107 | Radboudumc | Nijmegen | Netherlands | 6525 GA | |
| 108 | Elisabeth-TweeSteden Ziekenhuis | Tilburg | Netherlands | 5022 GC | |
| 109 | UMC Utrecht | Utrecht | Netherlands | 3584 CX | |
| 110 | Gastromed Kralisz Romatowski Stachurska Sp. j. | Bialystok | Poland | 15-322 | |
| 111 | Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy | Bydgoszcz | Poland | 85-164 | |
| 112 | Centrum Medyczne Promed | Krakow | Poland | 31-513 | |
| 113 | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | Poland | 71-434 | |
| 114 | WIP Warsaw IBD Point Profesor Kierkus | Warszawa | Poland | 00-728 | |
| 115 | ETG Zamosc | Zamosc | Poland | 22-400 | |
| 116 | Ccab - Hosp. de Braga | Braga | Portugal | 4710-243 | |
| 117 | Chlc - Hosp. Sto Antonio Dos Capuchos | Lisboa | Portugal | G1R 2J6 | |
| 118 | Hospital Beatriz Angelo | Loures | Portugal | 2674-514 | |
| 119 | H. Santo António - Centro Hospitalar do Porto | Porto | Portugal | 4099-001 | |
| 120 | King Fahad Specialist hospital | Dammam | Saudi Arabia | 31444 | |
| 121 | King Abdulaziz Medical City | Jeddah | Saudi Arabia | 21423 | |
| 122 | King Abdulaziz Medical City | Jeddah | Saudi Arabia | 80200 | |
| 123 | King Saud University Medical City | Riyadh | Saudi Arabia | 11472 | |
| 124 | King Faisal Specialist Hospital & Research Center | Riyadh | Saudi Arabia | 12713 | |
| 125 | Hosp. Clinic I Provincial de Barcelona | Barcelona | Spain | 08036 | |
| 126 | Hosp. Arquitecto Marcide | Ferrol | Spain | 15405 | |
| 127 | Hosp. Univ. de La Princesa | Madrid | Spain | 28006 | |
| 128 | Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | Spain | 28222 | |
| 129 | Hosp. Virgen Macarena | Sevilla | Spain | 41009 | |
| 130 | Hosp. Univ. Miguel Servet | Zaragoza | Spain | 50009 | |
| 131 | Linkoping University Hospital | Linköping | Sweden | 581 85 | |
| 132 | Ersta sjukhus | Stockholm | Sweden | 116 91 | |
| 133 | Danderyds Sjukhus | Stockholm | Sweden | 182 88 | |
| 134 | Changhua Christian Hospital | Changhua | Taiwan | 500 | |
| 135 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | Taiwan | 807 | |
| 136 | Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | |
| 137 | National Taiwan University Hospital | Taipei City | Taiwan | 10002 | |
| 138 | Chang Gung Memorial Hospital Linkou Branch | Taoyuan City | Taiwan | 333 | |
| 139 | Gazi University Medical Faculty | Ankara | Turkey | 06560 | |
| 140 | Istanbul University Cerrahpasa Medical Faculty | Istanbul | Turkey | 34098 | |
| 141 | Acibadem Kozyatagi Hospital | Istanbul | Turkey | 34734 | |
| 142 | Ege University Medical Faculty | İzmir | Turkey | 35100 | |
| 143 | Mersin University Medical Faculty Hospital | Mersin | Turkey | 33110 | |
| 144 | South Eastern Health and Social Care Trust | Belfast | United Kingdom | BT16 1RH | |
| 145 | University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom | B15 2GW | |
| 146 | Newcastle upon Tyne Hospitals NHS Foundation Trust | Gosforth | United Kingdom | NE3 3HD | |
| 147 | Hull University Teaching Hospitals NHS Trust | Hull | United Kingdom | HU3 2JZ | |
| 148 | London North West University Healthcare NHS Trust | London | United Kingdom | HA1 3UJ | |
| 149 | Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom | SE1 9RT | |
| 150 | St George's University Hosptial NHS Foundation Trust | London | United Kingdom | SW17 0QT | |
| 151 | Pennine Acute Hospitals NHS Trust | Salford | United Kingdom | M6 8HD |
Sponsors and Collaborators
- Janssen-Cilag Ltd.
Investigators
- Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109189
- 2021-000491-10
- CNTO1959CRD3005