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

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.
The participant is currently receiving Simponi ,or 2. The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or 3. The participant is scheduled to receive Simponi within 30 days after enrollment
  • - For Comparator cohort: 1.
The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry 2. Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment 3. Participant may have received biologics other than Simponi or investigational agents prior to enrollment

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 assessments

Trial Details

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.

Trial ID:
NCT02808780

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

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Janssen Biotech, Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Janssen Biotech, Inc. Clinical Trial
Principal Investigator Affiliation Janssen Biotech, Inc.

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Austria, Canada, Czechia, France, Germany, Greece, Italy, Korea, Republic of, Spain, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis
Study Website: View Trial Website
Additional Details

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.

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.

UCLA, Los Angeles, California

Status

Not yet recruiting

Address

UCLA

Los Angeles, California, 90095

United Gastroenterologists, Murrieta, California

Status

Recruiting

Address

United Gastroenterologists

Murrieta, California, 92563

Inland Empire Liver Foundation, Rialto, California

Status

Recruiting

Address

Inland Empire Liver Foundation

Rialto, California, 91106

Ventura Clinical Research, Ventura, California

Status

Recruiting

Address

Ventura Clinical Research

Ventura, California, 93003

Coral Gables Clinical Research, Inc, Coral Gables, Florida

Status

Completed

Address

Coral Gables Clinical Research, Inc

Coral Gables, Florida,

West Coast Clinical Research, LLC, Fort Myers, Florida

Status

Completed

Address

West Coast Clinical Research, LLC

Fort Myers, Florida, 33901

C & R Research Services, Lake Worth, Florida

Status

Recruiting

Address

C & R Research Services

Lake Worth, Florida, 33461

Precision Clinical Research, Lauderdale Lakes, Florida

Status

Completed

Address

Precision Clinical Research

Lauderdale Lakes, Florida, 33319

City Medical Group, RC, Miami, Florida

Status

Recruiting

Address

City Medical Group, RC

Miami, Florida, 33126

Medsearch Professional Group, Miami, Florida

Status

Recruiting

Address

Medsearch Professional Group

Miami, Florida, 33126

Sanitas Research, Miami, Florida

Status

Recruiting

Address

Sanitas Research

Miami, Florida, 33155

The Core Research Associates, Miami, Florida

Status

Completed

Address

The Core Research Associates

Miami, Florida, 33172

Guardian Angel Health Center, Tampa, Florida

Status

Recruiting

Address

Guardian Angel Health Center

Tampa, Florida, 33614

Atlanta Gastroenterology Specialists, PC, Suwanee, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, 30024

Northwestern University Hospital, Chicago, Illinois

Status

Not yet recruiting

Address

Northwestern University Hospital

Chicago, Illinois, 60611

The University Of Chicago Medicine, Chicago, Illinois

Status

Not yet recruiting

Address

The University Of Chicago Medicine

Chicago, Illinois, 60637

Gastrointestinal Associates LLP, Flowood, Mississippi

Status

Not yet recruiting

Address

Gastrointestinal Associates LLP

Flowood, Mississippi, 39232

Chi Health Research Center, Omaha, Nebraska

Status

Not yet recruiting

Address

Chi Health Research Center

Omaha, Nebraska, 68124

Sylvania, Ohio

Status

Not yet recruiting

Address

Promedica Physicians Digestive Healthcare

Sylvania, Ohio, 43560

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Houston Methodist Hospital, Houston, Texas

Status

Not yet recruiting

Address

Houston Methodist Hospital

Houston, Texas, 77030

San Antonio, Texas

Status

Withdrawn

Address

Gastroenterology Research of America, LLC

San Antonio, Texas, 78229

San Antonio, Texas

Status

Completed

Address

Gastroenterology Clinic Of San Antonio P A

San Antonio, Texas,

Emeritas Research Group, Lansdowne Town Center, Virginia

Status

Recruiting

Address

Emeritas Research Group

Lansdowne Town Center, Virginia, 20176

International Sites

KH.D Barmherzige Bruder Salzburg, Salzburg, Austria

Status

Recruiting

Address

KH.D Barmherzige Bruder Salzburg

Salzburg, ,

LKH Salzburg Medizin I, Salzburg, Austria

Status

Not yet recruiting

Address

LKH Salzburg Medizin I

Salzburg, ,

Sankt Poelten Noe, Austria

Status

Recruiting

Address

Allg. Krankenhaus der Landeshauptstadt St. Poelten

Sankt Poelten Noe, , 3100

Medical University Vienna, Vienna, Austria

Status

Not yet recruiting

Address

Medical University Vienna

Vienna, , 1130

Zeidler Ledcor Centre, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

Zeidler Ledcor Centre

Edmonton, Alberta, T6G 2X8

Columbia Gastroenterology, New Westminster, British Columbia, Canada

Status

Recruiting

Address

Columbia Gastroenterology

New Westminster, British Columbia, V3L 3W5

GIRI Gastrointestinal Research Institute, Vancouver, British Columbia, Canada

Status

Recruiting

Address

GIRI Gastrointestinal Research Institute

Vancouver, British Columbia, V6Z 2K5

Taunton Surgical Centre, Oshawa, Ontario, Canada

Status

Recruiting

Address

Taunton Surgical Centre

Oshawa, Ontario, L1H 7K4

Ottawa Hospital, Ottawa, Ontario, Canada

Status

Recruiting

Address

Ottawa Hospital

Ottawa, Ontario, K1H 8L6

RESEARCH SITE s.r.o., Plzen, Czechia

Status

Not yet recruiting

Address

RESEARCH SITE s.r.o.

Plzen, , 326 01

FN Motol, Prageu, Czechia

Status

Not yet recruiting

Address

FN Motol

Prageu, , 15006

CHRU de Tours - Hopital Trousseau, Chambray Les Tours Centre, France

Status

Not yet recruiting

Address

CHRU de Tours - Hopital Trousseau

Chambray Les Tours Centre, , 37170

CHU Estaing, Clermont-Ferrand, France

Status

Recruiting

Address

CHU Estaing

Clermont-Ferrand, , 63003

Hôpital Beaujon, Clichy, France

Status

Not yet recruiting

Address

Hôpital Beaujon

Clichy, , 92110

CHU Henri Mondor, Creteil, France

Status

Not yet recruiting

Address

CHU Henri Mondor

Creteil, , 94000

CHU Grenoble, Grenoble, France

Status

Recruiting

Address

CHU Grenoble

Grenoble, ,

Hopital Saint Eloi, Montpellier, France

Status

Recruiting

Address

Hopital Saint Eloi

Montpellier, , 34295

CHU de Nice Hopital de l Archet, Nice, France

Status

Not yet recruiting

Address

CHU de Nice Hopital de l Archet

Nice, , 6202

Hospices Civils de Lyon HCL, Pierre Bénite, France

Status

Recruiting

Address

Hospices Civils de Lyon HCL

Pierre Bénite, , 69495

CHU Saint-etienne, Saint Priest En Jarez, France

Status

Recruiting

Address

CHU Saint-etienne

Saint Priest En Jarez, , 42270

CHRU Hôpital de Hautepierre, Strasbourg Cedex, France

Status

Recruiting

Address

CHRU Hôpital de Hautepierre

Strasbourg Cedex, , 67098

Berlin-Karlshorst, Germany

Status

Not yet recruiting

Address

Gastroenterologische Spezialpraxis - Berlin-Karlshorst

Berlin-Karlshorst, , 10318

Berlin, Germany

Status

Recruiting

Address

Charité Universitatsmedizin Berlin, Campus Mitte Zentrum 13

Berlin, , 10117

Praxis Für Gastroenteroligie, Berlin, Germany

Status

Recruiting

Address

Praxis Für Gastroenteroligie

Berlin, , 10825

Charite Universitastmedizin Berlin, Berlin, Germany

Status

Not yet recruiting

Address

Charite Universitastmedizin Berlin

Berlin, , 13353

Dessau-Roßlau, Germany

Status

Not yet recruiting

Address

Städtisches Klinikum Dessau-Klinik Für Innere Medizin

Dessau-Roßlau, ,

Praxis Dr Zeisler, Halle, Germany

Status

Not yet recruiting

Address

Praxis Dr Zeisler

Halle, , 06108

Halle, Germany

Status

Recruiting

Address

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, , 06120

Hamburg, Germany

Status

Completed

Address

ifi-Institut für interdisziplinäre Medizin

Hamburg, , 20099

Hamburg, Germany

Status

Recruiting

Address

Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.

Hamburg, , 20251

Hannover Medical School, Hannover, Germany

Status

Not yet recruiting

Address

Hannover Medical School

Hannover, , 30625

University Hospital Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

University Hospital Heidelberg

Heidelberg, , 69120

Heidelberg, Germany

Status

Recruiting

Address

Gemeinschaftspraxis Dr Lars Helmstadter & Prof Dr Robert Ehehalt

Heidelberg, , 69121

Kiel, Germany

Status

Recruiting

Address

Universitätsklinikum Schlesw.-H., Campus Kiel/ Sektion für Stammzelll- und Immuntherapie - Germany

Kiel, , 24105

Universitatsklinikum Leipzig, Leipzig, Germany

Status

Recruiting

Address

Universitatsklinikum Leipzig

Leipzig, , 04103

Leipzig, Germany

Status

Recruiting

Address

Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten

Leipzig, , 04229

St Marien-Und St Annastiftskrankenhaus, Ludwigshafen, Germany

Status

Not yet recruiting

Address

St Marien-Und St Annastiftskrankenhaus

Ludwigshafen, , 67067

Städtisches Klinikum Lüneburg, Lyneburg, Lower Saxony, Germany

Status

Recruiting

Address

Städtisches Klinikum Lüneburg

Lyneburg, Lower Saxony, , 21330

Herbert Kellner, Muenchen, Germany

Status

Recruiting

Address

Herbert Kellner

Muenchen, , 80639

Gemeinschaftspraxis, Saarbrucken, Germany

Status

Recruiting

Address

Gemeinschaftspraxis

Saarbrucken, , 66111

Kreiskrankenhaus Sigmaringen, Sigmaringen, Germany

Status

Withdrawn

Address

Kreiskrankenhaus Sigmaringen

Sigmaringen, , 72488

Universitaetsklinik Tuebingen, Tübingen, Germany

Status

Withdrawn

Address

Universitaetsklinik Tuebingen

Tübingen, , 72076

Medical School, University of Athens., Athens, Greece

Status

Recruiting

Address

Medical School, University of Athens.

Athens, , 11527

Hippokration Hospital, Athens, Greece

Status

Recruiting

Address

Hippokration Hospital

Athens, , 11528

University Hospital of Heraklion, Heraklion, Greece

Status

Recruiting

Address

University Hospital of Heraklion

Heraklion, , 7110

Ioannina, Greece

Status

Recruiting

Address

Division Of Gastroenterology Medical School University Of Ioannina

Ioannina, , 45332

Hippokration Hospital, Thessaloniki, Greece

Status

Not yet recruiting

Address

Hippokration Hospital

Thessaloniki, , 54642

Catania, Italy

Status

Recruiting

Address

A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

Catania, , 95126

Ospedale Santissima Annunziata, Cento, Italy

Status

Recruiting

Address

Ospedale Santissima Annunziata

Cento, , 44042

Ospedale S. Maria Del Prato, Feltre, Italy

Status

Not yet recruiting

Address

Ospedale S. Maria Del Prato

Feltre, , 32032

Azienda Ospedaliera di Padova, Padova, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera di Padova

Padova, , 35128

Palermo, Italy

Status

Not yet recruiting

Address

UOC Gastroenterologia Ed Epatologia, Dibimis, Policlinico Palermo

Palermo, , 90143

Parma, Italy

Status

Not yet recruiting

Address

Gastroenterology And Endoscopy Unit, University Hospital Of Parma

Parma, , 43126

Rome, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario Al gemeli

Rome, , 00123

Rome, Italy

Status

Recruiting

Address

TOR Vergata University - U.O.C. Gastroenterologia Dipartimento Di Medicina

Rome, , 0133

Rozzano, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas Rozzano, IRCCS

Rozzano, , 20089

Gastroenterology Unit, Sardinia, Italy

Status

Not yet recruiting

Address

Gastroenterology Unit

Sardinia, , 9100

Torino, Italy

Status

Recruiting

Address

A.O.Citta della Salute e della Scienza di Torino

Torino, , 10126

Torino, Italy

Status

Recruiting

Address

A.O. Ordine Mauriziano Di Torino - Ospedale Mauriziano Umberto

Torino, , 10128

Pusan National University Hospital., Busan, Korea, Republic of

Status

Completed

Address

Pusan National University Hospital.

Busan, , 602-739

HanYang Univ. Guri Hospital, Gyeonggi-Do, Korea, Republic of

Status

Recruiting

Address

HanYang Univ. Guri Hospital

Gyeonggi-Do, , 471-701

Seongnam-Si, Korea, Republic of

Status

Recruiting

Address

Seoul National University Bundang Hospital

Seongnam-Si, , 463-707

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Hosp. Univ. A Coruña, A Coruna, Spain

Status

Recruiting

Address

Hosp. Univ. A Coruña

A Coruna, , 15009

Corporacio Sanitari Parc Tauli, Barcelona, Spain

Status

Not yet recruiting

Address

Corporacio Sanitari Parc Tauli

Barcelona, , 08208

Hosp. Univ. de Bellvitge, Barcelona, Spain

Status

Recruiting

Address

Hosp. Univ. de Bellvitge

Barcelona, , 08907

Hosp. Reina Sofia, Córdoba, Spain

Status

Recruiting

Address

Hosp. Reina Sofia

Córdoba, , 14004

Hosp. Univ. Fuenlabrada, Fuenlabrada, Spain

Status

Recruiting

Address

Hosp. Univ. Fuenlabrada

Fuenlabrada, , 28942

Hosp. Gral. Juan Ramon Jimenez, Huelva, Spain

Status

Recruiting

Address

Hosp. Gral. Juan Ramon Jimenez

Huelva, , 21005

Hosp. Univ. de La Princesa, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Univ. de La Princesa

Madrid, , 28006

Hosp. Gral. Univ. Gregorio Maranon, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , 28007

Hosp. Univ. La Paz, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. La Paz

Madrid, , 28046

Hosp. Univ. Fundacion Alcorcon, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Fundacion Alcorcon

Madrid, , 28922

Hosp. Clinico San Carlos, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Clinico San Carlos

Madrid, ,

Hosp. Univ. Pta. de Hierro Majadahonda, Majadahonda, Spain

Status

Recruiting

Address

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, , 28222

Fund. Hosp. de Manacor, Mallorca, Spain

Status

Not yet recruiting

Address

Fund. Hosp. de Manacor

Mallorca, , 07500

Hosp. Univ. Infanta Sofia, San Sebastian De Los Reyes, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Infanta Sofia

San Sebastian De Los Reyes, , 28702

Hosp. Virgen de La Salud, Toledo, Spain

Status

Not yet recruiting

Address

Hosp. Virgen de La Salud

Toledo, , 45004

Hosp. Clinico Univ. de Valencia, Valencia, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Valencia

Valencia, , 46010

Hosp. Clinico Univ. de Valencia, Valencia, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Valencia

Valencia, , 46014

Hosp. Univ. I Politecni La Fe-, Valencia, Spain

Status

Recruiting

Address

Hosp. Univ. I Politecni La Fe-

Valencia, , 46026

Hosp. Alvaro Cunqueiro, Vigo, Spain

Status

Recruiting

Address

Hosp. Alvaro Cunqueiro

Vigo, , 36312

Hosp. Univ. Miguel Servet, Zaragoza, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Miguel Servet

Zaragoza, , 50009

Hosp. Clinico Univ. Lozano Blesa, Zaragoza, Spain

Status

Not yet recruiting

Address

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, ,

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.