A Study of Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

Last Updated   August 10, 2019 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    18 - 65 years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    104 sites
  • Status
    Recruiting

SUMMARY

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).

CONDITIONS

  • Colitis, Ulcerative

ELIGIBILITY

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 0

Exclusion 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 excipients

DETAILS

LOCATIONS

Locations in:
Australia, Argentina, Germany, Brazil, Mexico, Poland, United States, Russia, Ukraine
City or Province (104) Country (9) Status
Darlinghurst, NSW St Vincent's hospital Australia
Withdrawn
Rosario, S Fundación de Estudios Clínicos Argentina
Not yet recruiting
Ulm, BW Universitaetsklinikum Ulm Germany
Not yet recruiting
Goiania Clinica De Gastroenterologia Brazil
Not yet recruiting
Porto Alegre Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS Brazil
Not yet recruiting
Botucatu, SP Universidade Estadual Paulista 'Julio De Mesquita Filho' Brazil
Not yet recruiting
Belo Horizonte HOSPITAL DAS CLINICAS DA UFMG Brazil
Not yet recruiting
Uberlândia, MG Eurolatino Pesquisas Médicas Brazil
Not yet recruiting
São Paulo Hospital Sirio Libanes Brazil
Not yet recruiting
Woodville South, SA The Queen Elizabeth Hospital Australia
Withdrawn
Berlin, BE DRK Kliniken Westend Germany
Withdrawn
San Pedro Garza Garcia Centro Medico Zambrano Hellion Mexico
Not yet recruiting
Mexico Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán Mexico
Not yet recruiting
South Brisbane, QLD Mater Hospital Brisbane (Inflammatory Bowel Diseases) Australia
Recruiting
Fitzroy, VIC Saint Vincent's Hospital - Melbourne Australia
Recruiting
Warszawa Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Poland
Recruiting
Warszawa Centrum Zdrowia MDM Poland
Recruiting
Monterrey Centro Regiomontano de Estudios Clínicos Roma S.C. Mexico
Not yet recruiting
Florencio Varela, B Hospital de Alta Complejidad en Red 'El Cruce' Argentina
Not yet recruiting
North Terrace, SA Royal Adelaide Hospital Australia
Not yet recruiting
Mentor, OH Great Lakes Gastroenterology Research, LLC United States
Withdrawn
Moscow LEC City Clinical Hospital # 24 Russia
Recruiting
Ekaterinburg Medical Association 'New Hospital' Russia
Recruiting
Yaroslavl Regional Clinical Hospital Russia
Recruiting
Kazan Kazan State Medical University Russia
Recruiting
Ufa GBUZ Respublican Clinical Hospital n.a. GG Kuvatova Russia
Recruiting
Saint Petersburg City Hospital #9 Russia
Withdrawn
Ufa City Clinical Hospital # 21 Russia
Withdrawn
St-Petersburg International Medical Centre SOGAZ Russia
Recruiting
Novosibirsk Medical Center 'SibNovoMed' LLC Russia
Recruiting
Saint Petersburg Elizavetinskaya hospital Russia
Recruiting
Saint Petersburg City Clinical Hospital #31 Russia
Recruiting
Rostov-On-Don Rostov State Medical University Russia
Recruiting
Novosibirsk Federal State Budgetary Institution 'Scientific Research Institute' Russia
Withdrawn
San Diego, CA Precision Research Institute United States
Recruiting
Las Vegas, NV Sierra Clinical Research United States
Recruiting
Chapel Hill, NC The University of North Carolina at Chapel Hill United States
Recruiting
Chernivtsi Chernivtsi Regional Clinical Hospital Ukraine
Withdrawn
Tacoma, WA Washington Gastroenterology, PLLC United States
Recruiting
Chesapeake, VA Gastroenterology Associates of Tidewater United States
Recruiting
Chevy Chase, MD Chevy Chase Clinical Research United States
Recruiting
Marrero, LA Tandem Clinical Research United States
Withdrawn
Parkville, VIC Royal Melbourne Hospital Australia
Recruiting
Saint Petersburg Clinical Hospital #122 n.a. after L.G. Sokolov Russia
Withdrawn
Saint-Petersburg City Hospital named after St. Martyr Elizabeth Russia
Withdrawn
Yaroslavl City Clinical Hospital #2 Russia
Recruiting
San Miguel de Tucuman, T Sanatorio 9 de Julio Argentina
Not yet recruiting
Ciudad Autonoma de Buenos Aires, B Hospital Britanico de Buenos Aires Argentina
Not yet recruiting
Houston, TX Baylor College of Medicine United States
Not yet recruiting
Tampa, FL GCP Clinical Research United States
Recruiting
Curitiba Hospital Nossa Senhora Das Gracas Brazil
Withdrawn
Rio de Janeiro, RJ UFRJ-Hospital Universitário Clementino Fraga Filho Brazil
Not yet recruiting
Rio de Janeiro, RJ Bioclinica Brazil
Not yet recruiting
São José do Rio Preto, SP Kaiser Hospta Brazil
Not yet recruiting
Saint Petersburg Leningrad Regional Clinical Hospital Russia
Withdrawn
Samara Medical University Reaviz Russia
Recruiting
Saint-Petersburg JSC CLINIC COMPLEX Russia
Withdrawn
Boca del Rio, VER Clínica Saluz Mexico
Not yet recruiting
Indianapolis, IN Indiana University United States
Not yet recruiting
Detroit, MI John D. Dingell VA Medical Center United States
Not yet recruiting
New South Wales, NSW Macquarie University Hospital Australia
Not yet recruiting
Seattle, WA Virginia Mason United States
Not yet recruiting
Sopot, PM Endoskopia Sp. z o.o. z siedzibą w Sopocie Poland
Recruiting
Colorado Springs, CO Peak Gastroenterology Associates United States
Recruiting
Tver Tver Regional Clinical Hospital Russia
Recruiting
Port Orange, FL Advanced Medical Research Center United States
Withdrawn
Caba, B Centro Médico Dra. De Salvo Argentina
Not yet recruiting
Tucson, AZ Southern Arizona VA Healthcare System United States
Withdrawn
Kharkiv SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine' Ukraine
Recruiting
Vinnytsya Medical Center Ltd 'Health Clinic', Department Of General Therapy Ukraine
Recruiting
Ternopil Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital' Ukraine
Recruiting
Odesa Odesa Regional Clinical Hospital Ukraine
Recruiting
Warsaw Centralny Szpital Kliniczny MSWiA w Warszawie Poland
Recruiting
Brisbane, QLD Princess Alexandra Hospital Australia
Recruiting
Kyiv Private Clinic OK Clinic Ukraine
Recruiting
Caba, B Expertia S.A Argentina
Recruiting
Fargo, ND Fargo Gastroenterology Clinic, PC United States
Recruiting
Glen Burnie, MD Woodholme Gastroenterology United States
Not yet recruiting
Mexico City Clinica Endomedix Mexico
Withdrawn
Ribeirão Preto Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo Brazil
Not yet recruiting
Vinnytsya Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov Ukraine
Recruiting
Marietta, GA Gastrointestinal Specialists of Georgia United States
Recruiting
Gdansk Synexus Polska Sp. z o.o. Oddzial w Gdansku Poland
Recruiting
Krakow Pratia MCM Krakow Poland
Recruiting
Jena Universitätsklinikum Jena Germany
Recruiting
Lviv Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway Ukraine
Recruiting
Mexico City Clinicos Asociados BOCM, SC Mexico
Not yet recruiting
Ciudad De Buenos Aires, B Clínica Adventista Belgrano Argentina
Not yet recruiting
Southlake, TX Texas Digestive Disease Consultants United States
Not yet recruiting
Saint-Petersburg Eco-safety Ltd Russia
Recruiting
Lviv Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' Ukraine
Recruiting
Kyiv Kyiv City Clinical Hospital #18 Ukraine
Recruiting
Kharkiv Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov' Ukraine
Recruiting
Kherson Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh' Ukraine
Recruiting
Zaporizhzhya Municipal Institution City Hospital Number 7 Ukraine
Withdrawn
Kingswood, NSW Nepean Hospital Australia
Recruiting
Wroclaw Melita Medical Sp. z o.o. Poland
Recruiting
Buenos Aires, B CEMIC (Centro de Educación Médica e Investigaciones Clínicas) Argentina
Recruiting
Buenos Aires, B Hospital Aleman Argentina
Withdrawn
Berlin, BE Charite Berlin Germany
Recruiting
Frankfurt Universitätsklinikum Frankfurt/ Medizinische Klinik 1 Germany
Recruiting
Santo Andre, SP FACULDADE DE MEDICINA DO ABC Brazil
Recruiting
Queretaro Capital Humano para la Investigacion clinica Mexico
Not yet recruiting
Sumy Sumy State University, Sumy Regional Clinical Hospital Ukraine
Not yet recruiting
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