A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Study Purpose
The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
Recruitment Criteria
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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years - 65 Years |
| Gender | All |
Inclusion Criteria:
- Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening - Moderately to severely active UC as defined by Mayo score - History of inadequate response to or failure to tolerate conventional therapy - Has screening laboratory test results within the study protocol defined parameters - A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0Exclusion Criteria:
- Has severe extensive colitis as defined in the study protocol - Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon - Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening - Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening) - Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipientsTrial Details
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This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03662542 |
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Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
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The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
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The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
| Principal Investigator Affiliation | Janssen Research & Development, LLC |
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Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Australia, Brazil, Germany, Mexico, Poland, Russian Federation, Ukraine, United States |
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The disease, disorder, syndrome, illness, or injury that is being studied. |
Colitis, Ulcerative |
| Study Website: | View Trial Website |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Washington Gastroenterology, PLLC
Tacoma, Washington, 98405
Status
Not yet recruiting
Address
Virginia Mason
Seattle, Washington, 98101
Status
Recruiting
Address
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Status
Not yet recruiting
Address
Baylor College of Medicine
Houston, Texas, 77030
Status
Withdrawn
Address
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Status
Recruiting
Address
Fargo Gastroenterology Clinic, PC
Fargo, North Dakota, 58103
Status
Recruiting
Address
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Status
Recruiting
Address
Sierra Clinical Research
Las Vegas, Nevada, 89106
Status
Not yet recruiting
Address
John D. Dingell VA Medical Center
Detroit, Michigan, 48201
Status
Not yet recruiting
Address
Woodholme Gastroenterology
Glen Burnie, Maryland, 21061
Status
Recruiting
Address
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Status
Withdrawn
Address
Tandem Clinical Research
Marrero, Louisiana, 70072
Status
Not yet recruiting
Address
Indiana University
Indianapolis, Indiana, 46202
Status
Not yet recruiting
Address
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
Status
Recruiting
Address
GCP Clinical Research
Tampa, Florida, 33609
Status
Withdrawn
Address
Advanced Medical Research Center
Port Orange, Florida, 32127
Status
Recruiting
Address
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Status
Recruiting
Address
Precision Research Institute
San Diego, California, 92114
Status
Withdrawn
Address
Southern Arizona VA Healthcare System
Tucson, Arizona, 85723
International Sites
Status
Not yet recruiting
Address
Municipal Institution City Hospital Number 7
Zaporizhzhya, , 69118
Status
Not yet recruiting
Address
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Vinnytsya, , 21018
Status
Recruiting
Address
Medical Center Ltd 'Health Clinic', Department Of General Therapy
Vinnytsya, , 21009
Status
Recruiting
Address
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, , 46002
Status
Recruiting
Address
Odesa Regional Clinical Hospital
Odesa, , 65025
Status
Not yet recruiting
Address
Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, , 79010
Status
Not yet recruiting
Address
Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway
Lviv, , 79007
Status
Recruiting
Address
Private Clinic OK Clinic
Kyiv, , 02091
Status
Not yet recruiting
Address
Kyiv City Clinical Hospital #18
Kyiv, , 01030
Status
Not yet recruiting
Address
Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'
Kherson, , 73003
Status
Recruiting
Address
SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine'
Kharkiv, , 61039
Status
Not yet recruiting
Address
Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'
Kharkiv, , 61037
Status
Withdrawn
Address
Chernivtsi Regional Clinical Hospital
Chernivtsi, , 58001
Status
Recruiting
Address
Regional Clinical Hospital
Yaroslavl, , 150062
Status
Recruiting
Address
City Clinical Hospital #2
Yaroslavl, , 150010
Status
Withdrawn
Address
City Clinical Hospital # 21
Ufa, , 450071
Status
Recruiting
Address
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
Ufa, , 450005
Status
Recruiting
Address
Tver Regional Clinical Hospital
Tver, , 170036
Status
Recruiting
Address
International Medical Centre SOGAZ
St-Petersburg, , 191186
Status
Recruiting
Address
Medical University Reaviz
Samara, , 443001
Status
Recruiting
Address
City Clinical Hospital # 26
Saint-Petersburg, , 196247
Status
Withdrawn
Address
City Hospital named after St. Martyr Elizabeth
Saint-Petersburg, , 195257
Status
Withdrawn
Address
Jsc Clinic Complex
Saint-Petersburg, , 190013
Status
Withdrawn
Address
City Hospital #9
Saint Petersburg, , 197110
Status
Recruiting
Address
City Clinical Hospital #31
Saint Petersburg, , 197110
Status
Recruiting
Address
Elizavetinskaya hospital
Saint Petersburg, , 195257
Status
Withdrawn
Address
Leningrad Regional Clinical Hospital
Saint Petersburg, , 194291
Status
Withdrawn
Address
Clinical Hospital #122 n.a. after L.G. Sokolov
Saint Petersburg, , 194291
Status
Recruiting
Address
Rostov State Medical University
Rostov-On-Don, , 344022
Status
Withdrawn
Address
Federal State Budgetary Institution 'Scientific Research Institute'
Novosibirsk, , 630117
Status
Recruiting
Address
Medical Center 'SibNovoMed' LLC
Novosibirsk, , 630005
Status
Recruiting
Address
LEC City Clinical Hospital # 24
Moscow, , 127015
Status
Recruiting
Address
Kazan State Medical University
Kazan, , 420012
Status
Recruiting
Address
Medical Association 'New Hospital'
Ekaterinburg, , 620109
Status
Recruiting
Address
Melita Medical Sp. z o.o.
Wroclaw, , 50-499
Status
Recruiting
Address
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warszawa, , 03 580
Status
Recruiting
Address
Centrum Zdrowia MDM
Warszawa, , 00-635
Status
Recruiting
Address
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, , 02-507
Status
Recruiting
Address
Endoskopia Sp. z o.o. z siedzibą w Sopocie
Sopot, , 81-756
Status
Not yet recruiting
Address
Pratia MCM Krakow
Krakow, , 30-510
Status
Not yet recruiting
Address
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, , 80-382
Status
Not yet recruiting
Address
Centro Medico Zambrano Hellion
San Pedro Garza Garcia, , 66278
Status
Not yet recruiting
Address
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, , 64610
Status
Not yet recruiting
Address
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Mexico, , 14080
Status
Withdrawn
Address
Clinica Endomedix
Mexico City, , 03100
Status
Not yet recruiting
Address
Clínica Saluz
Boca del Rio, , 94229
Status
Not yet recruiting
Address
Universitaetsklinikum Ulm
Ulm, , 89081
Status
Not yet recruiting
Address
Universitätsklinikum Jena
Jena, , 07740
Status
Not yet recruiting
Address
Universitätsklinikum Frankfurt/ Medizinische Klinik 1
Frankfurt, , 60590
Status
Withdrawn
Address
DRK Kliniken Westend
Berlin, , 14050
Status
Not yet recruiting
Address
Charite Berlin
Berlin, , 12203
Status
Not yet recruiting
Address
Eurolatino Pesquisas Médicas
Uberlândia, , 38400-368
Status
Not yet recruiting
Address
Hospital Sirio Libanes
São Paulo, , 13080-060
Status
Not yet recruiting
Address
Kaiser Hospta
São José do Rio Preto, , 15015-110
Status
Not yet recruiting
Address
Faculdade de Medicina Do Abc
Santo Andre, , 09060-870
Status
Not yet recruiting
Address
Bioclinica
Rio de Janeiro, , 22271-100
Status
Not yet recruiting
Address
UFRJ-Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, , 20050-902
Status
Not yet recruiting
Address
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, , 14098-900
Status
Not yet recruiting
Address
Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS
Porto Alegre, , 90035-903
Status
Not yet recruiting
Address
Clinica De Gastroenterologia
Goiania, , 74535-170
Status
Withdrawn
Address
Hospital Nossa Senhora Das Gracas
Curitiba, , 80810-040
Status
Not yet recruiting
Address
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu, , 18618-970
Status
Not yet recruiting
Address
Hospital Das Clinicas Da Ufmg
Belo Horizonte, , 30130-100
Status
Withdrawn
Address
The Queen Elizabeth Hospital
Woodville South, , 5011
Status
Recruiting
Address
Mater Hospital Brisbane (Inflammatory Bowel Diseases)
South Brisbane, , 4101
Status
Recruiting
Address
Royal Melbourne Hospital
Parkville, , 3050
Status
Not yet recruiting
Address
Royal Adelaide Hospital
North Terrace, , 5000
Status
Not yet recruiting
Address
Macquarie University Hospital
New South Wales, , 2109
Status
Not yet recruiting
Address
Nepean Hospital
Kingswood, , 2747
Status
Recruiting
Address
Saint Vincent's Hospital - Melbourne
Fitzroy, , 3065
Status
Withdrawn
Address
St Vincent's hospital
Darlinghurst, , 2010
Status
Withdrawn
Address
Concord Hospital
Concord, , 2139
Status
Recruiting
Address
Princess Alexandra Hospital
Brisbane, , 4102
Status
Not yet recruiting
Address
Sanatorio 9 de Julio
San Miguel de Tucuman, , 4000
Status
Not yet recruiting
Address
Fundación de Estudios Clínicos
Rosario, , 2000
Status
Not yet recruiting
Address
Hospital de Alta Complejidad en Red 'El Cruce'
Florencio Varela, , 1888
Status
Not yet recruiting
Address
Hospital Britanico de Buenos Aires
Ciudad Autonoma de Buenos Aires, , C1280AEB
Status
Not yet recruiting
Address
Centro Médico Dra. De Salvo
Caba, , C1426ABP
Status
Recruiting
Address
Expertia S.A
Caba, , C1128AAF
Status
Not yet recruiting
Address
Hospital Aleman
Buenos Aires, , C1118AAT
Status
Not yet recruiting
Address
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires, , 1431
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