A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Ulcerative Colitis (UC) Clinical Trial

Official title:

A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01848561
• Other study ID #: P11-282
• Status: Active, not recruiting
• Start date: April 29, 2013
• Est. completion date: June 24, 2030

Study information

• Verified date: June 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8250
• Est. completion date: June 24, 2030
• Est. primary completion date: June 24, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine

clinical practice and meets one of the following:

1. Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR

2. Is entering after participation in an Abbott or AbbVie sponsored UC study and; has received continuous HUMIRA therapy since initiation of therapy

• For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy
• Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol

Exclusion Criteria:

• Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or
• Patients who are being treated with any investigational agents and/or approved biologics other than Humira.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis (UC)

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital /ID# 158026	Adelaide	South Australia
Australia	Flinders Medical Centre /ID# 157979	Bedford, Park	South Australia
Australia	Box Hill Hospital /ID# 157987	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital /ID# 157986	Camperdown	New South Wales
Australia	Concord Repatriation General /ID# 157983	Concord	New South Wales
Australia	St Vincent's Hospital /ID# 157978	East Lismore	New South Wales
Australia	The Canberra Hospital /ID# 157980	Garran	Australian Capital Territory
Australia	Austin Health /ID# 157998	Heidelberg	Victoria
Australia	Royal Brisbane and Women's Hospital /ID# 158086	Herston	Queensland
Australia	Alfred Health /ID# 159261	Melbourne	Victoria
Australia	Fiona Stanley Hospital /ID# 157992	Murdoch	Western Australia
Australia	Hunter New England Local Health District /ID# 157999	New Lambton	New South Wales
Australia	The Royal Melbourne Hospital /ID# 157993	Parkville	Victoria
Australia	Mater Misericordiae Limited /ID# 164171	South Brisbane	Queensland
Austria	Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 120775	Innsbruck
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 98555	Linz	Oberoesterreich
Austria	Krankenhaus der Barmherzigen Brueder Salzburg /ID# 120776	Salzburg
Austria	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 127897	Salzburg
Austria	Klinik Landstrasse /ID# 121615	Vienna	Wien
Belgium	Onze Lieve Vrouw Hospital /ID# 127986	Aalst
Belgium	ZNA Middelheim /ID# 129116	Antwerp
Belgium	GZA St. Vincentiusziekenhuis /ID# 127398	Antwerpen
Belgium	Imelda Ziekenhuis /ID# 127497	Bonheiden
Belgium	Universitair Ziekenhuis Antwerpen /ID# 142757	Edegem	Antwerpen
Belgium	AZ Maria Middelares /ID# 127489	Gent
Belgium	AZ Sint-Lucas /ID# 127000	Gent
Belgium	UZ Gent /ID# 127985	Gent	Oost-Vlaanderen
Belgium	AZ Herentals /ID# 127135	Herentals
Belgium	Universitair Ziekenhuis Leuven /ID# 127984	Leuven	Vlaams-Brabant
Belgium	CHU de Liege /ID# 127983	Liege
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 127988	Liege
Belgium	Clinical Saint-Luc Bouge /ID# 127987	Namur
Belgium	Vitaz /Id# 141601	Sint-Niklaas
Belgium	Sint-Trudo Ziekenhuis /ID# 127136	Sint-truiden
Canada	Bellini Medicine Professional /ID# 145706	Brampton	Ontario
Canada	GI Research & Associates /ID# 133723	Edmonton	Alberta
Canada	University of Alberta - Zeidler Ledcor Centre /ID# 144673	Edmonton	Alberta
Canada	Dr. Everett Chalmers Reg Hosp. /ID# 135408	Fredericton	New Brunswick
Canada	Guelph GI and Surgery Clinic /ID# 128917	Guelph	Ontario
Canada	QE II Health Sciences Centre /ID# 128916	Halifax	Nova Scotia
Canada	Charlton Medical Centre /ID# 135390	Hamilton	Ontario
Canada	Duplicate_London Health Sciences Centre - University Hospital /ID# 128915	London	Ontario
Canada	CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 130321	Montreal	Quebec
Canada	CHUM - Notre-Dame Hospital /ID# 151379	Montréal	Quebec
Canada	Columbia Gastro Mgmnt Ltd /ID# 128719	New Westminster	British Columbia
Canada	Lakeridge Health - Oshawa /ID# 128275	Oshawa	Ontario
Canada	Hôpital Montfort /ID# 151588	Ottawa	Ontario
Canada	Ottawa Hospital Research Institute /ID# 128918	Ottawa	Ontario
Canada	Royal University Hospital /ID# 128720	Saskatoon	Saskatchewan
Canada	CHUS - Hopital Fleurimont /ID# 133031	Sherbrooke	Quebec
Canada	Dr. M. Prest Inc. /ID# 134309	Surrey	British Columbia
Canada	Kensington Screening Clinic /ID# 133720	Toronto	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 129095	Vancouver	British Columbia
Canada	University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 129995	Vancouver	British Columbia
Canada	Percuro Clinical Research, Ltd /ID# 129996	Victoria	British Columbia
Croatia	Klinicki bolnicki centar Osijek /ID# 127980	Osijek	Osjecko-baranjska Zupanija
Croatia	Klinicki bolnicki centar Rijeka /ID# 127979	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicki bolnicki centar Split /ID# 127978	Split	Splitsko-dalmatinska Zupanija
Croatia	Clinical Hospital Dubrava /ID# 127982	Zagreb	Grad Zagreb
Croatia	General Hospital Sveti Duh /ID# 127977	Zagreb
Denmark	Aalborg University Hospital /ID# 119215	Aalborg	Nordjylland
Denmark	Rigshospitalet /ID# 98238	Copenhagen Ø	Hovedstaden
Denmark	Herlev Hospital /ID# 98239	Herlev	Hovedstaden
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 120557	Hvidovre	Hovedstaden
France	CHU Amiens-Picardie Site Sud /ID# 98637	Amiens CEDEX 1	Somme
France	Hospitalier Germon et Gauthier /ID# 137874	Bethune
France	CHU Clermont-Ferrand /ID# 98735	Clermont	Auvergne-Rhone-Alpes
France	Hopital Beaujon /ID# 127395	Clichy	Ile-de-France
France	CHU Grenoble - Hopital Michallon /ID# 98638	La Tronche
France	CHRU Lille - Hopital Claude Huriez /ID# 98737	Lille	Hauts-de-France
France	Centre des consultations spécialisées de la sauvegarde /ID# 98719	Lyon
France	HCL - Hopital Edouard Herriot /ID# 155711	Lyon	Rhone
France	Duplicate_CHU Hopital Nord /ID# 98639	Marseille	Bouches-du-Rhone
France	Cabinet medical Dr ECUER /ID# 161671	Metz
France	GHI Le Raincy - Montfermeil /ID# 98642	Montfermeil
France	CHU Montpellier - Hôpital Saint Eloi /ID# 217142	Montpellier Cedex 5	Herault
France	Chu de Nice-Hopital L'Archet Ii /Id# 98645	Nice	Alpes-Maritimes
France	AP-HP - Hopital Bichat - Claude-Bernard /ID# 98641	Paris
France	AP-HP - Hopital Cochin /ID# 98717	Paris
France	AP-HP - Hopital Saint-Antoine /ID# 141611	Paris
France	Duplicate_APHP - Groupe Hospitalier 1 /ID# 98736	Paris
France	HCL - Hopital Lyon Sud /ID# 98718	Pierre Benite CEDEX	Auvergne-Rhone-Alpes
France	CHU Reims - Hôpital Robert Debre /ID# 98640	Reims CEDEX	Marne
France	Hôpital Charles-Nicolle /ID# 98721	Rouen
France	Cabinet Médical - Dr THEVENIN /ID# 98720	Saint Quentin
France	CHU de SAINT ETIENNE - Hopital Nord /ID# 130978	St. Priest En Jarez	Loire
France	CHU Toulouse - Hopital Rangueil /ID# 147755	Toulouse
France	CHU Toulouse - Hopital Purpan /ID# 148183	TOULOUSE Cedex 9	Haute-Garonne
France	Duplicate_Hopital Trousseau /ID# 98716	Tours
France	CHRU Nancy - Hopitaux de Brabois /ID# 127394	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
France	GH Mutualiste Les Portes Du Sud /ID# 98722	Venissieux
Germany	Klinikum Altenburger Land /ID# 131748	Altenburg
Germany	Praxis Dres. Roesler und Lachma /ID# 128466	Bayreuth
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 130318	Berlin
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 129115	Berlin
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 129117	Berlin
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 98124	Berlin
Germany	DRK Kliniken Berlin Westend /ID# 98179	Berlin
Germany	Praxis Dr. Michael Mross /ID# 98117	Berlin
Germany	Krankenhaus Waldfriede /ID# 98200	Berlin-Zehlendorf
Germany	Klinikum Ruhr Univ Bochum /ID# 148107	Bochum
Germany	Stadtisches Klinikum Braunschweig /ID# 98123	Braunschweig
Germany	Klinikum Dortmund gGmbH /ID# 127061	Dortmund
Germany	Universitaetsklinikum Erlangen /ID# 128179	Erlangen	Bayern
Germany	Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 98196	Essen
Germany	Universitaetsklinikum Freiburg /ID# 98176	Freiburg	Baden-Wuerttemberg
Germany	Klinikum Garmisch-Partenkirchen /ID# 127915	Garmisch-Partenkirchen
Germany	Dr. Zeisler, Halle, DE /ID# 98218	Halle
Germany	Krankenhaus Martha-Maria Halle-Doelau /ID# 122935	Halle (Saale)	Sachsen-Anhalt
Germany	Asklepios Klinik St. Georg /ID# 125216	Hamburg
Germany	Asklepios Westklinikum Hamburg /ID# 127492	Hamburg
Germany	Forstep /ID# 125206	Hamburg
Germany	Gastroenterologie Fontenay /ID# 98195	Hamburg
Germany	Gastroenterologie Studien -CED /ID# 98205	Hamburg
Germany	Graefin v.Waldersee&Partner, H /ID# 141607	Hamburg
Germany	Israelitisches Krankenhaus Hamburg /ID# 98197	Hamburg
Germany	Magen-Darm-Zentrum /ID# 141610	Hamburg
Germany	Mueller/Mueller-Ziehm, Hanover /ID# 130490	Hannover
Germany	Ehehalt/Helmstadter, Heidelber /ID# 125211	Heidelberg
Germany	Universitaetsklinik Heidelberg /ID# 98120	Heidelberg	Baden-Wuerttemberg
Germany	Gastroenterologische Gemeinschaftspraxis Herne /ID# 98121	Herne	Nordrhein-Westfalen
Germany	Hoffstadt, Iserlohn, DE /ID# 98208	Iserlohn
Germany	Universitaetsklinikum Jena /ID# 127496	Jena	Thueringen
Germany	Gastroenterologisch - Hepatologisches MVZ Kiel GmbH /ID# 127798	Kiel
Germany	Benner & Dommermuth /ID# 129119	Koblenz
Germany	EUGASTRO GmbH /ID# 98178	Leipzig
Germany	Internistische Gemienschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen /ID# 98119	Leipzig
Germany	Universitaetsklinikum Leipzig /ID# 98116	Leipzig	Sachsen
Germany	St. Marien- und Annastiftskrankenhaus /ID# 98235	Ludwigshafen
Germany	Otto-von-Guericke-Universitaet /ID# 129227	Magdeburg
Germany	Universitatsklinikum Mannheim /ID# 129279	Mannheim	Baden-Wuerttemberg
Germany	Internistisches Fachzentrum /ID# 123255	Memmingen
Germany	Gastroenterologische Gemeinschaftspraxis Minden /ID# 98115	Minden
Germany	Gastro Campus Research GbR /ID# 125558	Muenster
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 98122	Muenster
Germany	LMU Klinikum Campus Grosshadern /ID# 98198	München
Germany	Gastroenterologie Im Josephinu /ID# 123496	Munich
Germany	Isar Medizin Zentrum /ID# 125213	Munich
Germany	Klinikum Neumarkt /ID# 123016	Neumarkt
Germany	Innere Am Stadtpark /ID# 123015	Nuremberg
Germany	Klinikum Nuernberg Nord /ID# 134976	Nuremberg
Germany	Helwig, Oldenburg, DE /ID# 129120	Oldenburg
Germany	Praxiszentrum Altemalzerei /ID# 129001	Regensburg
Germany	Universitaetsklinikum Regensburg /ID# 141606	Regensburg
Germany	Universitaetsmedizin Rostock /ID# 128396	Rostock
Germany	Biewer/Mohl, Saarbruecken, DE /ID# 98204	Saarbruecken
Germany	Ambulanzzentrum Schweinfurt /ID# 123238	Schweinfurt
Germany	Bank, Schwerin, DE /ID# 125215	Schwerin
Germany	Clinics of Sigmaringen /ID# 98216	Sigmaringen
Germany	Ctr Gastro & Hepatology Stade /ID# 98206	Stade
Germany	Kardalinos, Stuhr, DE /ID# 98201	Stuhr
Germany	Universitaetsklinikum Ulm /ID# 98202	Ulm	Baden-Wuerttemberg
Germany	Internistische Praxisgemeinschaft /ID# 129000	Weyhe
Germany	Loehr, Wiesbaden, DE /ID# 98217	Wiesbaden
Greece	General University Hospital of Alexandroupolis /ID# 128636	Alexandroupolis
Greece	HYGEIA Hospital /ID# 128637	Amaroussio	Attiki
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 98756	Athens
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 98761	Athens
Greece	General Hospital of Athens Ippokratio /ID# 128638	Athens	Attiki
Greece	General Hospital of Athens Laiko /ID# 129280	Athens	Attiki
Greece	Venizeleio General Hospital /ID# 98757	Heraklion
Greece	University General Hospital of Ioannina /ID# 127390	Ioannina
Greece	Iatriko Kentro Athinon /ID# 98762	Marousi	Attiki
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 127400	Thessaloniki
Greece	Theageneio Anticancer Hospital /ID# 141670	Thessaloniki
Ireland	Connolly Hospital Blanchardstown /ID# 98895	Abbotstown	Dublin
Ireland	Beaumont Hospital /ID# 98775	Beaumont	Dublin
Ireland	Duplicate_Adelaide and Meath Hosp,IE /ID# 117947	Dublin 24
Ireland	Mater Misericordiae Univ Hospital /ID# 119054	Dublin 7	Dublin
Ireland	St James Hospital /ID# 149406	Dublin 8	Dublin
Ireland	St Vincent's University Hospital /ID# 116835	Elm Park	Dublin
Ireland	Duplicate_Galway University Hospital /ID# 98763	Galway
Israel	Assaf Harofeh Medical Center /ID# 128996	Be'Er Ya'Akov
Israel	Hillel Yaffe Medical Center /ID# 129047	Hadera
Israel	Rambam Health Care Campus /ID# 129282	Haifa
Israel	Clalit Health Services /ID# 129237	Jerusalem
Israel	Gastroenterology Institute, Division of Medicine /ID# 132530	Jerusalem
Israel	Shaare Zedek Medical Center /ID# 126638	Jerusalem
Israel	Meir Medical Center /ID# 129238	Kfar Saba
Israel	Zavulun Medical Centre /ID# 129048	Kiriat Bialik
Israel	Duplicate_Baruch-Padeh Poriya Medical /ID# 141671	Lower Galilee
Israel	The Chaim Sheba Medical Center /ID# 129281	Ramat Gan	Tel-Aviv
Italy	Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 144213	Bari
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 137945	Bologna
Italy	ASST Spedali civili di Brescia /ID# 137943	Brescia
Italy	Fondazione Poliambulanza Istituto Ospedaliero /ID# 141593	Brescia
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 138142	Catania
Italy	Ospedale Valduce /ID# 155712	Como
Italy	Azienda Ospedaliero Universitaria Careggi /ID# 137946	Florence
Italy	Ospedale Policlinico San Martino /ID# 137947	Genoa	Genova
Italy	A.O.U. Policlinico G. Martino /ID# 144212	Messina
Italy	Ospedale S Giuseppe /ID# 141395	Milan
Italy	Policlinico San Donato /ID# 141383	Milan
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 137944	Milano
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 141716	Milano
Italy	Duplicate_Seconda Universita' di Napoli /ID# 141717	Naples
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 141381	Napoli
Italy	Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 144084	Novara
Italy	Azienda Ospedaliera di Padova /ID# 137941	Padova
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 141392	Palermo
Italy	Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 141397	Palermo
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 144211	Rome	Lazio
Italy	Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 144080	Rome	Lazio
Italy	Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 141393	Rome	Lazio
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 141396	Rome	Lazio
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 145912	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 141382	Rozzano	Milano
Italy	Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 137939	San Giovanni Rotondo	Foggia
Italy	AO Ordine Mauriziano Umberto I /ID# 137942	Turin
Italy	Duplicate_A.O. Circolo e Fondazione Macc /ID# 141394	Varese
Mexico	Investigacion y Biomedicina de Chihuahua /ID# 150115	Chihuahua
Mexico	Clinica de Higado & Gastroenterologia Integral SC /ID# 128376	Cuernavaca	Morelos
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 129318	Guadalajara	Jalisco
Mexico	Instituto de Salud Digestiva /ID# 157435	Guadalajara	Jalisco
Mexico	Issste /Id# 128386	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion S.C. /ID# 131390	Leon	Guanajuato
Mexico	Torre de Especialidades Medica /ID# 154276	Metepec
Mexico	Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 138113	Mexico City
Mexico	Umsi /Id# 149283	Mexico City
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 128375	Monterrey	Nuevo Leon
Mexico	Ruiz Flores, Monterrey, MX /ID# 128379	Monterrey NL
Mexico	Asociacion Mexicana para la Investigacion Clinica /ID# 128387	Pachuca	Hidalgo
Mexico	Vega Fonseca, San Luis Potosi /ID# 128380	San Luis Potosi
Netherlands	Meander Medisch Centrum /ID# 98338	Amersfoort
Netherlands	Onze Lieve Vrouwe Gasthuis /ID# 98336	Amsterdam
Netherlands	Rijnstate /ID# 127397	Arnhem
Netherlands	Zuyderland Medisch Centrum /ID# 98241	Heerlen	Limburg
Netherlands	Leids Universitair Medisch Centrum /ID# 127402	Leiden
Netherlands	Erasmus Medisch Centrum /ID# 98337	Rotterdam	Zuid-Holland
Netherlands	Franciscus Gasthuis & Vlietland /ID# 127904	Rotterdam
Netherlands	Isala /ID# 98317	Zwolle
New Zealand	Christchurch Hospital /ID# 164265	Christchurch	Canterbury
Norway	Akershus Universitetssykehus_MAIN /ID# 127159	Lorenskog	Akershus
Puerto Rico	Perez Jimenz Gastroenterologo /ID# 110135	Mayaguez
Puerto Rico	Gastro-Hepato & Geriatric Ctr /ID# 113135	Ponce
Puerto Rico	Henry A. Rodriguez Ginorio, MD /ID# 113448	San Juan
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 102067	San Juan
Spain	Hospital Universitario A Coruna - CHUAC /ID# 129002	A Coruna
Spain	Hospital Universitario Principe de Asturias /ID# 131751	Alcala de Henares	Madrid
Spain	Hospital General La Mancha Centro /ID# 98588	Alcazar de San Juan	Ciudad Real
Spain	Hospital Universitario Fundacion Alcorcon /ID# 98576	Alcorcon	Madrid
Spain	Hospital General Universitario de Alicante Doctor Balmis /ID# 128467	Alicante
Spain	Hospital Alto Guadalquivir /ID# 129006	Andujar	Jaen
Spain	Hospital de Antequera /ID# 129041	Antequera	Malaga
Spain	Hospital Universitario Germans Trias i Pujol /ID# 98592	Badalona	Barcelona
Spain	Hospital San Eloy /ID# 147830	Barakaldo	Vizcaya
Spain	Hospital de Sant Joan Despi Moises Broggi /ID# 128347	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 126637	Barcelona
Spain	Hospital Universitario Basurto /ID# 129123	Bilbao	Vizcaya
Spain	Hospital San Pedro de Alcantara /ID# 98579	Caceres
Spain	Hospital General Universitario Santa Lucia /ID# 129125	Cartagena	Murcia
Spain	Hospital General de Castellon /ID# 128351	Castellon de la Plana	Castellon
Spain	Hospital Universitario Reina Sofia /ID# 98586	Cordoba
Spain	Hospital General Universitario de Elche /ID# 129121	Elche	Alicante
Spain	Hospital Sant Joan de Deu /ID# 151342	Esplugues de Llobregat	Barcelona
Spain	Hospital Sant Joan de Deu /ID# 155774	Esplugues de Llobregat	Barcelona
Spain	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 129124	Ferrol	A Coruna
Spain	Hospital Universitario de Fuenlabrada /ID# 98591	Fuenlabrada	Madrid
Spain	Hospital Universitario de Galdakao /ID# 98618	Galdakao	Vizcaya
Spain	Hospital de Cabuenes /ID# 141998	Gijon	Asturias
Spain	Hospital Universitario de Girona Doctor Josep Trueta /ID# 130049	Girona
Spain	Hospital San Jorge Huesca /ID# 149628	Huesca
Spain	Hospital Universitario de Jaen /ID# 129035	Jaen
Spain	Hospital Universitario de Jerez de la Frontera /ID# 128345	Jerez de la Frontera	Cadiz
Spain	Hospital Universitario de Bellvitge /ID# 98584	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Dr. Negrin /ID# 98578	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital de Leon /ID# 131750	Leon
Spain	Hospital Clinico Universitario San Carlos /ID# 98577	Madrid
Spain	Hospital General Universitario Gregorio Maranon /ID# 98558	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 98575	Madrid
Spain	Hospital Universitario de la Princesa /ID# 98580	Madrid
Spain	Hospital Universitario La Paz /ID# 98582	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 98596	Madrid
Spain	Hospital Universitario Virgen de la Victoria /ID# 129038	Malaga
Spain	Hospital de Manacor /ID# 128348	Manacor	Balears
Spain	Hospital General de Mostoles /ID# 130319	Mostoles	Madrid
Spain	Hospital Comarcal Santa Ana de Motril /ID# 129040	Motril	Granada
Spain	Complejo Hospitalario Universitario Ourense /ID# 128349	Orense	Ourense
Spain	Hospital Universitario Central de Asturias /ID# 98617	Oviedo	Asturias
Spain	Hospital Universitari Son Espases /ID# 148214	Palma de Mallorca	Illes Balears
Spain	Hospital Universitario Infanta Cristina /ID# 98635	Parla	Madrid
Spain	Complejo Hospitalario Universitario de Pontevedra /ID# 128354	Pontevedra
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 98585	Sabadell	Barcelona
Spain	Hospital de Sagunto /ID# 98587	Sagunto	Valencia
Spain	Hospital Universitario Canarias /ID# 129037	San Cristóbal de La Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario San Juan de Alicante /ID# 130167	San Juan de Alicante	Alicante
Spain	Hospital Infanta Sofia /ID# 98615	San Sebastián de Los Reyes	Madrid
Spain	Hospital Unversitario Marques de Valdecilla /ID# 98581	Santander	Cantabria
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 98619	Santiago de Compostela	A Coruna
Spain	Hospital General de Segovia /ID# 148926	Segovia
Spain	Hospital Universitario Virgen de Valme /ID# 129036	Sevilla
Spain	Hospital Universitario Virgen del Rocio /ID# 98557	Sevilla
Spain	Hospital Universitario Virgen Macarena /ID# 128346	Sevilla
Spain	Hospital Unide Tarragona /ID# 129122	Tarragona
Spain	Hospital Virgen de la Salud /ID# 98595	Toledo
Spain	Hospital Clinico Universitario de Valencia /ID# 131749	Valencia
Spain	Hospital General Universitario de Valencia /ID# 98616	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 98597	Valencia
Spain	Hospital Rio Hortega /ID# 98590	Valladolid
Spain	Hospital Meixoeiro (CHUVI) /ID# 128355	Vigo	Pontevedra
Spain	Hospital Xeral Cies (CHUVI) /ID# 129515	Vigo	Pontevedra
Spain	Hospital de Viladecans /ID# 155500	Viladecans	Barcelona
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 98556	Zaragoza
Spain	Hospital Royo Villanova /ID# 149850	Zaragoza
Spain	Hospital Universitario Miguel Servet /ID# 131188	Zaragoza
Sweden	Sahlgrenska University Hospital /ID# 141672	Gothenburg	Vastra Gotalands Lan
Sweden	Skaraborgs Sjukhus Skovde /ID# 98898	Skovde
Sweden	Capio St Gorans Sjukhus /ID# 126123	Stockholm	Stockholms Lan
Sweden	Danderyd Hospital /ID# 98897	Stockholm	Stockholms Lan
Sweden	Karolinska University Hospital /ID# 171247	Stockholm
Sweden	Sodersjukhuset /ID# 124158	Stockholm
Sweden	Uppsala University Hospital /ID# 120558	Uppsala
United Kingdom	Hampshire Hospitals NHS Foundation Trust /ID# 98900	Basingstoke	Essex
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust /ID# 164213	Blackpool
United Kingdom	West Suffolk Hospital /ID# 164105	Bury St Edmunds	Suffolk
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 145704	Cambridge
United Kingdom	UH Coventry & Warwickshire /ID# 145680	Coventry
United Kingdom	County Durham and Darlington NHS Foundation Trust /ID# 145914	Darlington
United Kingdom	The Dudley Group NHS Foundation Trust /ID# 164119	Dudley
United Kingdom	Kaiser Perm Riverside Med Ctr /ID# 146043	Fontana
United Kingdom	NHS Greater Glasgow and Clyde /ID# 153818	Glasgow	Scotland
United Kingdom	James Paget University Hospitals NHS Foundation Trust /ID# 164106	Great Yarmouth	Norfolk
United Kingdom	London North West University Healthcare NHS Trust /ID# 145953	Harrow
United Kingdom	Hull University Teaching Hospitals NHS Trust /ID# 98899	Hull	East Riding Of Yorkshire
United Kingdom	Isle of Wight NHS Trust /ID# 168166	ISLE OF Wight
United Kingdom	The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 145937	Kings Lynn	Norfolk
United Kingdom	Kingston Hospital NHS Foundation Trust /ID# 164109	Kingston upon Thames	England
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 157949	Leeds
United Kingdom	Barts Health NHS Trust /ID# 145703	London	London, City Of
United Kingdom	Imperial College Healthcare NHS Trust /ID# 145916	London
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 145698	London
United Kingdom	Manchester University NHS Foundation Trust /ID# 145702	Manchester
United Kingdom	Nottingham University Hospitals NHS Trust /ID# 145678	Nottingham	Nottinghamshire
United Kingdom	University Hospital Plymouth NHS Trust /ID# 157432	Plymouth
United Kingdom	University Hospitals Dorset NHS Foundation Trust /ID# 164108	Poole
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 145676	Southampton	Hampshire
United Kingdom	Stockport NHS foundation trust /ID# 144090	Stockport
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust /ID# 144089	Warrington	Cheshire West And Chester
United Kingdom	The Royal Wolverhampton NHS Trust /ID# 164209	Wolverhampton
United Kingdom	The Royal Wolverhampton NHS Trust /ID# 98901	Wolverhampton
United Kingdom	Yeovil District Hospital NHS Foundation Trust /ID# 146042	Yeovil
United States	Huron Gastroenterology Assoc /ID# 132484	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 105836	Ann Arbor	Michigan
United States	Investigative Clinical Research /ID# 102056	Annapolis	Maryland
United States	Northwest Gastro, S.C. /ID# 103620	Arlington Heights	Illinois
United States	Northwest Gastro, S.C. /ID# 145707	Arlington Heights	Illinois
United States	Asheville Gastro Assoc /ID# 144367	Asheville	North Carolina
United States	Atlanta Gastro Assoc /ID# 107164	Atlanta	Georgia
United States	Emory Midtown Infectious Disease Clinic /ID# 133724	Atlanta	Georgia
United States	Attleboro Gastroenterology, PC /ID# 113899	Attleboro	Massachusetts
United States	University of Maryland School of Medicine /ID# 116897	Baltimore	Maryland
United States	Birmingham Gastroenterology Associates P.C /ID# 102063	Birmingham	Alabama
United States	University of Alabama at Birmingham - Main /ID# 131646	Birmingham	Alabama
United States	Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 148230	Brandon	Florida
United States	Gastro Assoc of Fair County /ID# 113443	Bridgeport	Connecticut
United States	Commonwealth Clinical Studies /ID# 118597	Brockton	Massachusetts
United States	University of Vermont Medical Center /ID# 102075	Burlington	Vermont
United States	Cary Gastroenterology Assoc PA /ID# 108198	Cary	North Carolina
United States	Christie Clinic, LLC /ID# 116258	Champaign	Illinois
United States	Univ NC Chapel Hill /ID# 102059	Chapel Hill	North Carolina
United States	Medical University of South Carolina /ID# 113439	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 126970	Charlotte	North Carolina
United States	Carolina Digestive Health Associates /ID# 108199	Charlotte	North Carolina
United States	Carolinas Research center /ID# 211288	Charlotte	North Carolina
United States	Charlotte Gastroenterology and Hepatology, PLLC /ID# 102058	Charlotte	North Carolina
United States	Erlanger Institute for Clinical Research /ID# 126151	Chattanooga	Tennessee
United States	Gastro Assoc of Tidewater /ID# 102061	Chesapeake	Virginia
United States	MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 107157	Chevy Chase	Maryland
United States	Northwestern University Feinberg School of Medicine /ID# 126760	Chicago	Illinois
United States	Rush University Medical Center /ID# 132979	Chicago	Illinois
United States	The University of Chicago Medical Center /ID# 114115	Chicago	Illinois
United States	Cleveland Clinic Main Campus /ID# 108055	Cleveland	Ohio
United States	Iowa Digestive Disease Center /ID# 107159	Clive	Iowa
United States	Consultants in Gastroenterology - Columbia NE /ID# 126517	Columbia	South Carolina
United States	Gastro Center of Maryland /ID# 126969	Columbia	Maryland
United States	Southern California Res. Ctr. /ID# 116898	Coronado	California
United States	Duplicate_Bierwirth, Cranston, RI /ID# 113435	Cranston	Rhode Island
United States	Henry Ford Health System /ID# 103617	Detroit	Michigan
United States	NorthShore University HealthSystem /ID# 107165	Evanston	Illinois
United States	Gastro Assoc. of N. Va. /ID# 125495	Fairfax	Virginia
United States	Detroit Clinical Research Center /ID# 123235	Farmington Hills	Michigan
United States	Franklin Endoscopy Center /ID# 113444	Franklin	Tennessee
United States	Sarkis Clinical Trials /ID# 137948	Gainesville	Florida
United States	Atlantic Gastroenterology, PA /ID# 135536	Greenville	North Carolina
United States	Carolina Research /ID# 134133	Greenville	North Carolina
United States	Greenville Endoscopy Center /ID# 129900	Greenville	South Carolina
United States	Medical Research Center of CT /ID# 102057	Hamden	Connecticut
United States	Penn State University and Milton S. Hershey Medical Center /ID# 133688	Hershey	Pennsylvania
United States	Hollywood Research Center /Id# 214723	Hollywood	Florida
United States	Houma Digestive Health Special /ID# 125711	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 103636	Houston	Texas
United States	Houston Digestive Dis Clinic /ID# 102076	Houston	Texas
United States	Houston Endoscopy and Research Center /ID# 206978	Houston	Texas
United States	Kelsey-Seybold Clinic /ID# 125942	Houston	Texas
United States	Precision Research Institute, LLC /ID# 211340	Houston	Texas
United States	University of Texas MD Anderson Cancer Center /ID# 144198	Houston	Texas
United States	Longwood Research /ID# 118662	Huntsville	Alabama
United States	Grand Teton Research Group /ID# 108197	Idaho Falls	Idaho
United States	University of Iowa Hospitals and Clinics /ID# 134432	Iowa City	Iowa
United States	Clinical Research Solutions /ID# 154153	Jackson	Tennessee
United States	Univ of Mississippi Med Ctr,US /ID# 132981	Jackson	Mississippi
United States	Univ Kansas Med Ctr /ID# 120917	Kansas City	Kansas
United States	University of Kansas Health Sy /ID# 134436	Kansas City	Kansas
United States	Moores Cancer Center at UC San Diego /ID# 133722	La Jolla	California
United States	McGuire, Jr. La Mirada, CA /ID# 116257	La Mirada	California
United States	Gastro Clinic of Acadiana, LA /ID# 119155	Lafayette	Louisiana
United States	NYU Langone Long Island Clinical Research Associates /ID# 107163	Lake Success	New York
United States	Emeritas Research Group, LLC /ID# 135537	Leesburg	Virginia
United States	Atay, Los Alamitos, CA /ID# 110175	Los Alamitos	California
United States	Orlin & Cohen /ID# 117895	Lynbrook	New York
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 117838	Macon	Georgia
United States	St. Mary's Hospital /ID# 116915	Madison	Wisconsin
United States	Univ of Wisconsin Hosp/Clinics /ID# 103637	Madison	Wisconsin
United States	Ctr for Advanced Gastroenterol /ID# 116236	Maitland	Florida
United States	Main Line Gastro Assoc /ID# 113446	Malvern	Pennsylvania
United States	Rio Grande Gastroenterology /ID# 210218	McAllen	Texas
United States	Abel & Buchheim, P.R., Inc. /ID# 143863	Miami	Florida
United States	Paradise Clnical Research, LLC /ID# 212027	Miami	Florida
United States	Research Associates of South Florida,LLC /ID# 148212	Miami	Florida
United States	Duplicate_Clinical Research Solutions /ID# 207698	Middleburg Heights	Ohio
United States	Middlesex Hospital /ID# 122077	Middletown	Connecticut
United States	Froedtert Memorial Lutheran Hospital /ID# 102066	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 103616	Milwaukee	Wisconsin
United States	Progressive Gastroenterology Consultants /ID# 105835	Mineola	New York
United States	Alabama Medical Group, PC /ID# 116259	Mobile	Alabama
United States	Mobile Medical & Diagnostic Center, AL /ID# 102064	Mobile	Alabama
United States	Reach /Id# 116256	Monroe	Wisconsin
United States	Morgantown Surgical Associates /ID# 123082	Morgantown	West Virginia
United States	Cooper Digestive Health Instit /ID# 103615	Mount Laurel	New Jersey
United States	Mid-State Gastroenterology /ID# 125457	Murfreesboro	Tennessee
United States	Temecula Valley Endoscopy Ctr /ID# 118660	Murrieta	California
United States	Gastroenterology Group Naples /ID# 105837	Naples	Florida
United States	Yale Univ Digestive Diseases /ID# 141987	New Haven	Connecticut
United States	Digestive Disease Care /ID# 133489	New Hyde Park	New York
United States	North Shore University Hospital /ID# 127948	New Hyde Park	New York
United States	Advanced Research Institute, Inc /ID# 211335	New Port Richey	Florida
United States	Premier Medical Group /ID# 140388	New Windsor	New York
United States	Manhattan Clinical Research, LLC /ID# 113442	New York	New York
United States	The Mount Sinai Hospital /ID# 108201	New York	New York
United States	Weill Cornell Medical College /ID# 135052	New York	New York
United States	Westside Gastroenterology /ID# 133689	New York	New York
United States	Digestive and Liver Disease Sp /ID# 125943	Norfolk	Virginia
United States	Arkansas Gastroenterology /ID# 113898	North Little Rock	Arkansas
United States	DM Clinical Research/Southwest /ID# 120635	Oak Lawn	Illinois
United States	Care Access Research /ID# 213432	Ogden	Utah
United States	CHI Health Research Center /ID# 116255	Omaha	Nebraska
United States	Community Clinical Trials, CA /ID# 117335	Orange	California
United States	North Florida Gastro Research /ID# 128538	Orange Park	Florida
United States	Advent Health /ID# 145705	Orlando	Florida
United States	Combined Research Orlando - Phase I-IV /ID# 141660	Orlando	Florida
United States	Endoscopic Research, Inc. /ID# 136883	Orlando	Florida
United States	Digestive Diseases Center /ID# 118116	Panama City	Florida
United States	North Suburban Gastro Assoc /ID# 134437	Park Ridge	Illinois
United States	Palekar. Parkland, FL /ID# 108202	Parkland	Florida
United States	Digestive Health Center /ID# 113897	Pasadena	Texas
United States	Drexel University /ID# 126968	Philadelphia	Pennsylvania
United States	Methodist Hospital /ID# 129461	Philadelphia	Pennsylvania
United States	Temple University Hospital /ID# 108203	Philadelphia	Pennsylvania
United States	HOPE Research Institute /ID# 127947	Phoenix	Arizona
United States	Digestive Health Assoc of TX /ID# 116215	Plano	Texas
United States	BRCR Medical Center Inc /ID# 152015	Plantation	Florida
United States	Advanced Medical Research Center /ID# 116235	Port Orange	Florida
United States	Northwest Gastroenterology Clinic /ID# 116896	Portland	Oregon
United States	Premier Medical Group - GI Division /ID# 140384	Poughkeepsie	New York
United States	Rapid City Medical Center - GI Research /ID# 201191	Rapid City	South Dakota
United States	Gastoenterology Group of Rochester /ID# 113438	Rochester	New York
United States	Mayo Clinic - Rochester /ID# 116899	Rochester	Minnesota
United States	University of Rochester Medical Center /ID# 126152	Rochester	New York
United States	Boice-Willis Clinic, P.A. /ID# 103618	Rocky Mount	North Carolina
United States	St. Louis University /ID# 163794	Saint Louis	Missouri
United States	Washington University-School of Medicine /ID# 107156	Saint Louis	Missouri
United States	Gastroenterology Clinic of San /ID# 113441	San Antonio	Texas
United States	San Antonio Gastro Assoc /ID# 143435	San Antonio	Texas
United States	Digestive Care Medical Center /ID# 122075	San Carlos	California
United States	Precision Research Institute - San Diego /ID# 103638	San Diego	California
United States	Precision Research Institute - San Diego /ID# 113445	San Diego	California
United States	Santa Monica Research Institut /ID# 118675	Santa Monica	California
United States	Guthrie Medical Group, PC /ID# 105838	Sayre	Pennsylvania
United States	University of Washington /ID# 122076	Seattle	Washington
United States	Louisana Research Center, LLC /ID# 102055	Shreveport	Louisiana
United States	Singaram Gastroenterology /ID# 113447	Sioux Falls	South Dakota
United States	Precision Clinical Research /ID# 127849	Sunrise	Florida
United States	Atlanta Gastroenterology Spec /ID# 103619	Suwanee	Georgia
United States	ProMedica Physicians Digestive Healthcare /ID# 156529	Sylvania	Ohio
United States	Digestive Disease Clinic /ID# 107162	Tallahassee	Florida
United States	Guardian Angels Health Center /ID# 209706	Tampa	Florida
United States	University of South Florida /ID# 213305	Tampa	Florida
United States	Baylor Scott & White Medical Center- Temple /ID# 103639	Temple	Texas
United States	Endoscopic Microsurgery Assoc /ID# 102065	Towson	Maryland
United States	University of Arizona /ID# 117836	Tucson	Arizona
United States	University of Arizona Cancer Center - North Campus /ID# 140387	Tucson	Arizona
United States	Digestive Health Spec of Tyler /ID# 138144	Tyler	Texas
United States	Carle Foundation Hospital Digestive Health Research Center /ID# 117417	Urbana	Illinois
United States	The Gastro Group of S. Jersey /ID# 129902	Vineland	New Jersey
United States	Gastroenterology Ltd. /ID# 103640	Virginia Beach	Virginia
United States	Allied Gastrointestinal Associates /ID# 107158	Voorhees	New Jersey
United States	Avamar Center for Endoscopy /ID# 113440	Warren	Ohio
United States	Georgetown University Hospital /ID# 113437	Washington	District of Columbia
United States	South Florida Ctr Gastro, P.A. /ID# 166784	Wellington	Florida
United States	Confluence Health /ID# 118661	Wenatchee	Washington
United States	Biocentric Healthcare Research /ID# 213980	West Columbia	South Carolina
United States	Granger Medical Clinic /ID# 122896	West Valley City	Utah
United States	Duplicate_Western States Clinical Research, Inc. /ID# 116237	Wheat Ridge	Colorado
United States	Kansas Gasteroenterology /ID# 214827	Wichita	Kansas
United States	Ctr Digest, Allergic & Imm Dis /ID# 125502	Williamsville	New York
United States	Trial Management Associates /ID# 138459	Wilmington	North Carolina
United States	Wake Forest Univ HS /ID# 113436	Winston-Salem	North Carolina
United States	Shafran Gastroenterology Ctr /ID# 117839	Winter Park	Florida
United States	St. Joseph Heritage Group /ID# 133721	Yorba Linda	California
United States	Southwoods Surgical Hospital /ID# 133038	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Croatia,  Denmark,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Mexico,  Netherlands,  New Zealand,  Norway,  Puerto Rico,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC		10 years observational period
Secondary	Evaluation of long term effectiveness of Adalimumab in patients with moderately to severely active UC who have had an inadequate response to conventional therapy		10 years observational period

External Links

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