An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Study Purpose
The purpose of this study is to compare the incidence of lymphoma in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with thiopurines.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
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. |
Observational |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria:
- - Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past - For enrollment into the Simponi-exposed cohort meets one of the following: 1.
- - For Comparator cohort: 1.
Exclusion Criteria:
- Participants who cannot be treated with Simponi or thiopurines - Participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment - Participants currently receiving an investigational or biologic agent other than Simponi - Participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessmentsTrial Details
Trial ID:
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. |
NCT02808780 |
Phase
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. |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Biotech, Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Biotech, Inc. Clinical Trial |
Principal Investigator Affiliation | Janssen Biotech, Inc. |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Austria, Canada, Czechia, France, Germany, Greece, Italy, Korea, Republic of, Spain, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ulcerative Colitis |
Study Website: | View Trial Website |
This is an observational prospective long-term exposure registry of adult participants with moderate-to-severe ulcerative colitis. Two cohorts, a Simponi-exposed cohort and a comparator cohort treated with thiopurines, will be enrolled in study. Approximately 6,000 participants are planned for enrollment, with 3,000 participants in the Simponi-exposed cohort and 3,000 participants in the comparator cohort. Participants will receive treatments in a routine clinical setting as prescribed by their physician. After enrollment, during the 10-year follow-up period, a participant may stop his or her ulcerative colitis treatment regimen and switch to a new treatment regimen. Lymphoma incidence will be primarily assessed by a questionnaire that will be sent to the investigator to obtain complete medical information about each case. An expert panel of medical specialists with extensive experience in lymphoma will be convened to validate cases of lymphoma. Besides assessing the incidence of lymphoma, long-term safety will be evaluated by capturing other adverse events of interest and serious adverse events.
Arms
: Simponi-exposed cohort
Participants receiving Simponi at enrollment and are still receiving Simponi after participation in a therapeutic trial or participants scheduled to receive Simponi within 30 days after enrollment. Participants in this cohort may be receiving Simponi alone or in combination with thiopurines but must not be receiving other approved biologics or investigational agents at enrollment. Participants may have received other approved biologics or investigational agents prior to enrollment.
: comparator cohort
Participants currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry. Participants must not be receiving approved biologic agents, including Simponi, or investigational agents at enrollment. These patients may have received biologics other than Simponi or investigational agents prior to enrollment.
Interventions
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
Completed
Address
United Gastroenterologists
Murrieta, California, 92563
Site Contact
Status
Completed
Address
Inland Empire Liver Foundation
Rialto, California, 91106
Site Contact
Status
Completed
Address
Ventura Clinical Trials
Ventura, California, 93003
Site Contact
Status
Completed
Address
Coral Gables Clinical Research, Inc
Coral Gables, Florida,
Site Contact
Status
Completed
Address
West Coast Clinical Research, LLC
Fort Myers, Florida, 33901
Site Contact
Status
Completed
Address
C & R Research Services
Lake Worth, Florida, 33461
Site Contact
Status
Completed
Address
Precision Clinical Research
Lauderdale Lakes, Florida, 33319
Site Contact
Status
Completed
Address
City Medical Group, RC
Miami, Florida, 33126
Site Contact
Status
Completed
Address
Medsearch Professional Group
Miami, Florida, 33126
Site Contact
Status
Completed
Address
The Core Research Associates
Miami, Florida, 33172
Site Contact
Status
Recruiting
Address
Guardian Angel Health Center
Tampa, Florida, 33614
Site Contact
Status
Recruiting
Address
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 30024
Site Contact
Status
Withdrawn
Address
Northwestern University Hospital
Chicago, Illinois, 60611
Site Contact
Status
Recruiting
Address
The University Of Chicago Medicine
Chicago, Illinois, 60637
Site Contact
Status
Withdrawn
Address
Gastrointestinal Associates LLP
Flowood, Mississippi, 39232
Site Contact
Status
Withdrawn
Address
Chi Health Research Center
Omaha, Nebraska, 68124
Site Contact
Status
Recruiting
Address
Promedica Physicians Digestive Healthcare
Sylvania, Ohio, 43560
Site Contact
Status
Recruiting
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Site Contact
Status
Recruiting
Address
Houston Methodist Hospital
Houston, Texas, 77030
Site Contact
Status
Withdrawn
Address
Gastroenterology Research of America, LLC
San Antonio, Texas, 78229
Site Contact
Status
Completed
Address
Gastroenterology Clinic Of San Antonio P A
San Antonio, Texas,
Site Contact
Status
Completed
Address
Emeritas Research Group
Lansdowne Town Center, Virginia, 20176
Site Contact
International Sites
Status
Recruiting
Address
KH.D Barmherzige Bruder Salzburg
Salzburg, ,
Site Contact
Status
Recruiting
Address
Allg. Krankenhaus der Landeshauptstadt St. Poelten
Sankt Poelten Noe, , 3100
Site Contact
Status
Withdrawn
Address
Zeidler Ledcor Centre
Edmonton, Alberta, T6G 2X8
Site Contact
Status
Recruiting
Address
Columbia Gastroenterology
New Westminster, British Columbia, V3L 3W5
Site Contact
Status
Recruiting
Address
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5
Site Contact
Status
Recruiting
Address
Taunton Surgical Centre
Oshawa, Ontario, L1H 7K4
Site Contact
Status
Withdrawn
Address
CHRU de Tours - Hopital Trousseau
Chambray Les Tours Centre, , 37170
Site Contact
Status
Recruiting
Address
CHU de Nice Hopital de l Archet
Nice, , 6202
Site Contact
Status
Recruiting
Address
Hospices Civils de Lyon HCL
Pierre Bénite, , 69495
Site Contact
Status
Recruiting
Address
CHU Saint-etienne
Saint Priest en jarez, , 42270
Site Contact
Status
Completed
Address
CHRU Hôpital de Hautepierre
Strasbourg Cedex, , 67098
Site Contact
Status
Withdrawn
Address
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
Berlin-Karlshorst, , 10318
Site Contact
Status
Recruiting
Address
Charité Universitatsmedizin Berlin, Campus Mitte Zentrum 13
Berlin, , 10117
Site Contact
Status
Recruiting
Address
Praxis Für Gastroenteroligie
Berlin, , 10825
Site Contact
Status
Withdrawn
Address
Charite Universitastmedizin Berlin
Berlin, , 13353
Site Contact
Status
Recruiting
Address
Städtisches Klinikum Dessau-Klinik Für Innere Medizin
Dessau-Roßlau, ,
Site Contact
Status
Recruiting
Address
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, , 06120
Site Contact
Status
Completed
Address
ifi-Institut für interdisziplinäre Medizin
Hamburg, , 20099
Site Contact
Status
Recruiting
Address
Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.
Hamburg, , 20251
Site Contact
Status
Recruiting
Address
University Hospital Heidelberg
Heidelberg, , 69120
Site Contact
Status
Completed
Address
Gemeinschaftspraxis Dr Lars Helmstadter & Prof Dr Robert Ehehalt
Heidelberg, , 69121
Site Contact
Status
Recruiting
Address
Universitätsklinikum Schlesw.-H., Campus Kiel/ Sektion für Stammzelll- und Immuntherapie - Germany
Kiel, , 24105
Site Contact
Status
Recruiting
Address
Universitatsklinikum Leipzig
Leipzig, , 04103
Site Contact
Status
Recruiting
Address
Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten
Leipzig, , 04105
Site Contact
Status
Recruiting
Address
St Marien-Und St Annastiftskrankenhaus
Ludwigshafen, , 67067
Site Contact
Status
Recruiting
Address
Städtisches Klinikum Lüneburg
Lyneburg, Lower Saxony, , 21330
Site Contact
Status
Withdrawn
Address
Kreiskrankenhaus Sigmaringen
Sigmaringen, , 72488
Site Contact
Status
Withdrawn
Address
Universitaetsklinik Tuebingen
Tübingen, , 72076
Site Contact
Status
Recruiting
Address
Medical School, University of Athens.
Athens, , 11527
Site Contact
Status
Recruiting
Address
University Hospital of Heraklion
Heraklion, , 7110
Site Contact
Status
Recruiting
Address
Division Of Gastroenterology Medical School University Of Ioannina
Ioannina, , 45332
Site Contact
Status
Recruiting
Address
Hippokration Hospital
Thessaloniki, , 54642
Site Contact
Status
Recruiting
Address
A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale
Catania, , 95126
Site Contact
Status
Recruiting
Address
Ospedale Santissima Annunziata
Cento, , 44042
Site Contact
Status
Recruiting
Address
Ospedale S. Maria Del Prato
Feltre, , 32032
Site Contact
Status
Withdrawn
Address
Azienda Ospedaliera di Padova
Padova, , 35128
Site Contact
Status
Completed
Address
UOC Gastroenterologia Ed Epatologia, Dibimis, Policlinico Palermo
Palermo, , 90143
Site Contact
Status
Recruiting
Address
Gastroenterology And Endoscopy Unit, University Hospital Of Parma
Parma, , 43126
Site Contact
Status
Recruiting
Address
Fondazione Policlinico Universitario Al gemeli
Rome, , 00123
Site Contact
Status
Completed
Address
TOR Vergata University - U.O.C. Gastroenterologia Dipartimento Di Medicina
Rome, , 0133
Site Contact
Status
Recruiting
Address
Istituto Clinico Humanitas Rozzano, IRCCS
Rozzano, , 20089
Site Contact
Status
Recruiting
Address
A.O.Citta della Salute e della Scienza di Torino
Torino, , 10126
Site Contact
Status
Completed
Address
A.O. Ordine Mauriziano Di Torino - Ospedale Mauriziano Umberto
Torino, , 10128
Site Contact
Status
Completed
Address
Pusan National University Hospital.
Busan, , 602-739
Site Contact
Status
Recruiting
Address
HanYang Univ. Guri Hospital
Gyeonggi-Do, , 471-701
Site Contact
Status
Recruiting
Address
Seoul National University Bundang Hospital
Seongnam-Si, , 463-707
Site Contact
Status
Recruiting
Address
Seoul National University Hospital
Seoul, , 3080
Site Contact
Status
Recruiting
Address
Corporacio Sanitari Parc Tauli
Barcelona, , 08208
Site Contact
Status
Recruiting
Address
Hosp. Univ. de Bellvitge
Barcelona, , 08907
Site Contact
Status
Recruiting
Address
Hosp. Univ. Fuenlabrada
Fuenlabrada, , 28942
Site Contact
Status
Recruiting
Address
Hosp. Gral. Juan Ramon Jimenez
Huelva, , 21005
Site Contact
Status
Recruiting
Address
Hosp. Univ. de La Princesa
Madrid, , 28006
Site Contact
Status
Recruiting
Address
Hosp. Gral. Univ. Gregorio Marañon
Madrid, , 28007
Site Contact
Status
Recruiting
Address
Hosp. Univ. Fundacion Alcorcon
Madrid, , 28922
Site Contact
Status
Recruiting
Address
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, , 28222
Site Contact
Status
Recruiting
Address
Hosp. Univ. Infanta Sofia
San Sebastian De Los Reyes, , 28702
Site Contact
Status
Recruiting
Address
Hosp. Clinico Univ. de Valencia
Valencia, , 46010
Site Contact
Status
Recruiting
Address
Hosp. Clinico Univ. de Valencia
Valencia, , 46014
Site Contact
Status
Recruiting
Address
Hosp. Univ. I Politecni La Fe-
Valencia, , 46026
Site Contact
Status
Recruiting
Address
Hosp. Univ. Miguel Servet
Zaragoza, , 50009
Site Contact
Status
Recruiting
Address
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, ,
Site Contact
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