Clinical trial NCT02738125: Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
Official title: Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis (UC)
Keywords: Adalimumab
Ulcerative Colitis
SOTHIS
Effectiveness
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects starting/ receiving Adalimumab for UC

Brief summary: This study assesses the long?term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.


Eligibility criteria: Inclusion Criteria:

* Suffering from ulcerative colitis
* Naïve from Adalimumab
* Starting a treatment with adalimumab
* Capable of and willing to grant authorization for use/disclosure of data collected
* Able to read, understand, and complete patients questionnaires

Exclusion Criteria:

- None

Primary outcomes:
measure: Time to loss of clinical benefit
timeFrame: Up to Month 120
Secondary outcomes:
measure: Change from Baseline (Month 0) in Steroid-free remission
timeFrame: From Month 0 to Month 120
measure: Change from Baseline (Month 0) in Clinical Remission
timeFrame: From Month 0 to Month 120
measure: Change from Baseline (Month 0) in Clinical Response
timeFrame: From Month 0 to Month 120
Other outcomes:
Locations:
city: Nice
country: France
facility: Chu de Nice-Hopital L'Archet Ii /Id# 151132
state: Alpes-Maritimes
city: Nice
country: France
facility: Chu de Nice-Hopital L'Archet Ii /Id# 151181
state: Alpes-Maritimes
city: Clermont
country: France
facility: CHU Clermont-Ferrand /ID# 153527
state: Auvergne-Rhone-Alpes
city: Pierre Benite CEDEX
country: France
facility: HCL - Hôpital Lyon Sud /ID# 151146
state: Auvergne-Rhone-Alpes
city: Pierre Benite CEDEX
country: France
facility: HCL - Hôpital Lyon Sud /ID# 151505
state: Auvergne-Rhone-Alpes
city: Pierre Benite CEDEX
country: France
facility: HCL - Hôpital Lyon Sud /ID# 165859
state: Auvergne-Rhone-Alpes
city: Marseille
country: France
facility: Hopital Saint Joseph /ID# 164405
state: Bouches-du-Rhone
city: Marseille
country: France
facility: APHM - Hopital Nord /ID# 152620
state: Bouches-du-Rhone
city: Nimes CEDEX 9
country: France
facility: CHU NIMES - Hopital Caremeau /ID# 169178
state: Gard
city: BAIE Mahault
country: France
facility: Cabinet Medical /ID# 155460
state: Guadeloupe
city: TOULOUSE Cedex 9
country: France
facility: CHU Toulouse - Hopital Purpan /ID# 167179
state: Haute-Garonne
city: PRINGY cedex
country: France
facility: CH Annecy Genevois Site Annecy /ID# 151131
state: Haute-Savoie
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 151514
state: Hauts-de-France
city: Clichy
country: France
facility: Hopital Beaujon /ID# 151498
state: Ile-de-France
city: St. Priest En Jarez
country: France
facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 166807
state: Loire
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy - Hôpitaux de Brabois /ID# 151147
state: Meurthe-et-Moselle
city: Avignon CEDEX 9
country: France
facility: CH Henri Duffaut /ID# 151383
state: Provence-Alpes-Cote-d Azur
city: Avignon CEDEX 9
country: France
facility: CH Henri Duffaut /ID# 151499
state: Provence-Alpes-Cote-d Azur
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote /ID# 163714
state: Pyrenees-Atlantiques
city: Creteil
country: France
facility: Centre Hosp Intercommunal de Creteil /ID# 152361
state: Val-de-Marne
city: Amiens
country: France
facility: Centre Medical Alexandre Dumas /Id# 165857
city: Aulnay Sous Bois Cedex
country: France
facility: Duplicate_Hopital Robert Ballanger /ID# 151382
city: Bordeaux
country: France
facility: Polyclinique du Tondu /ID# 161977
city: Bourgoin Jallieu
country: France
facility: Centre Endo Nord Isere /ID# 151390
city: Brest
country: France
facility: Geier, Cabinet Medical /ID# 149652
city: Brest
country: France
facility: Hopital de la Cavale Blanche /ID# 152618
city: Brest
country: France
facility: Hopital de la Cavale Blanche /ID# 153608
city: Caen
country: France
facility: Cabinet Medical /ID# 151391
city: Chambray Les Tours
country: France
facility: CHRU Tours - Hopital Trousseau /ID# 163503
city: Chambray Les Tours
country: France
facility: Pole Sante Leonard de Vinci /ID# 151384
city: Chateau Gontier
country: France
facility: CH du Haut Anjou /ID# 151151
city: Chauny
country: France
facility: Ch Chauny /Id# 151149
city: Colombe
country: France
facility: Hopital Louis Mourier,Colombes /ID# 152650
city: Creil
country: France
facility: GHPSO CH Creil /ID# 151117
city: Douarnenez
country: France
facility: Cabinet Medical /ID# 150978
city: Erstein
country: France
facility: Cabinet Medical /ID# 150845
city: Gien
country: France
facility: Centre Gastro Loire /ID# 151387
city: Grasse
country: France
facility: Clinique du Palais /ID# 151175
city: La Rochelle
country: France
facility: CH La Rochelle - Hopital Saint Louis /ID# 151182
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 151508
city: Limoges
country: France
facility: Duplicate_HOPITAL DUPUYTREN /ID# 157889
city: Longjumeau
country: France
facility: CH Des Deux Vallees Longumeau /ID# 150977
city: Lyon
country: France
facility: HCL - Hopital Edouard Herriot /ID# 151513
city: Lyon
country: France
facility: Centre des consultations spécialisées de la sauvegarde /ID# 151515
city: Montigny Les Cormeilles
country: France
facility: Centre Medical Les Sources /ID# 151174
city: Paris
country: France
facility: AP-HP - Hopital Saint-Louis /ID# 151509
city: Paris
country: France
facility: Hopital Paris Saint-Joseph /ID# 153526
city: Paris
country: France
facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 151176
city: Paris
country: France
facility: Cabinet Medical /ID# 151118
city: Paris
country: France
facility: Cabinet Medical /ID# 152362
city: Pierre Benite
country: France
facility: Duplicate_CHU LYON SUD /ID# 153801
city: Plerin
country: France
facility: Cabinet Medical /ID# 151092
city: Plerin
country: France
facility: Cabinet Medical /ID# 151093
city: Plerin
country: France
facility: Cabinet Medical /ID# 151094
city: Poissy
country: France
facility: Cabinet Medical /ID# 151148
city: Prades-le-lez
country: France
facility: Cabinet Medical /ID# 151555
city: Rennes
country: France
facility: CHRU Pontchaillou /ID# 166806
city: Saint-Denis
country: France
facility: CHU La Réunion - site St Denis - Félix-Guyon /ID# 151556
city: Salouel
country: France
facility: CHU d'Amiens /ID# 152651
city: Saverne
country: France
facility: Cabinet Medical /ID# 151558
city: St Nazaire
country: France
facility: Centre de Consultations /ID# 151128
city: St Nazaire
country: France
facility: Centre de Consultations /ID# 151164
city: St Nazaire
country: France
facility: Centre de Consultations /ID# 155458
city: St Quentin
country: France
facility: Cabinet Medical /ID# 151559
city: Strasbourg
country: France
facility: Cabinet Medical /ID# 151162
city: Sucy En Brie
country: France
facility: Centre Medical du Clos de Pacy /ID# 151129
city: Talence CEDEX
country: France
facility: Maison de Santé Protestante Bordeaux Bagatelle /ID# 151497
city: Toulon
country: France
facility: Cabinet Medical, Dr. Constant, /ID# 151119
city: Toulouse CEDEX 3
country: France
facility: Clinique Pasteur /ID# 151088
city: Toulouse CEDEX 3
country: France
facility: Clinique Pasteur /ID# 155792
city: Toulouse
country: France
facility: Clinique Ambroise Pare /ID# 161978
city: Toulouse
country: France
facility: Cabinet Medical /ID# 170136
city: Toulouse
country: France
facility: Cabinet Medical /ID# 152841
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Rangueil /ID# 157890
city: Tours
country: France
facility: Duplicate_Hopital Trousseau /ID# 150168
city: Troyes
country: France
facility: Cabinet Medical /ID# 151557
city: Venissieux
country: France
facility: GH Mutualiste Les Portes Du Sud /ID# 152374
city: Venissieux
country: France
facility: GH Mutualiste Les Portes Du Sud /ID# 159231
city: Villejuif
country: France
facility: Centre Hépato-Biliaire - Hopital Paul-Brousse /ID# 151152
city: Voiron
country: France
facility: Cabinet Medical /ID# 152617
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: