Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
- Conditions
- Ulcerative Colitis (UC)
- Registration Number
- NCT02738125
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
- Suffering from ulcerative colitis
- NaΓ―ve 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to loss of clinical benefit Up to Month 120 Loss of clinical benefit will be defined as one of the following: loss of efficacy leading to adalimumab discontinuation or introduction/reinforcement of aminosalicylates, 6-mercaptopurine, or azathioprine, introduction or reinforcement of corticosteroids (any route), UC-related surgery, discontinuation of adalimumab due to adverse event, death.
- Secondary Outcome Measures
Name Time Method Change from Baseline (Month 0) in Steroid-free remission From Month 0 to Month 120 Steroid- free remission is defined as partial Mayo score \<= 2 with no subscore \>1 and no daily intake of prednisone.
Change from Baseline (Month 0) in Clinical Remission From Month 0 to Month 120 Clinical remission is defined as partial Mayo score \<= 2 with no subscore \>1
Change from Baseline (Month 0) in Clinical Response From Month 0 to Month 120 Clinical response is decrease in partial Mayo score \>= 3 points and \>= 30% from baseline plus a decrease in rectal bleeding subscore \>= 1 or an absolute rectal bleeding subscore \<= 1.
Trial Locations
- Locations (80)
CHU La RΓ©union - site St Denis - FΓ©lix-Guyon /ID# 151556
π«π·Saint-Denis, France
Cabinet Medical /ID# 155460
π«π·BAIE Mahault, Guadeloupe, France
CHU Toulouse - Hopital Purpan /ID# 167179
π«π·TOULOUSE Cedex 9, Haute-Garonne, France
CHRU Nancy - HΓ΄pitaux de Brabois /ID# 151147
π«π·VandΕuvre-lΓ¨s-Nancy, Meurthe-et-Moselle, France
HCL - Hopital Edouard Herriot /ID# 151513
π«π·Lyon, France
Ch Chauny /Id# 151149
π«π·Chauny, France
Hopital Louis Mourier,Colombes /ID# 152650
π«π·Colombe, France
Cabinet Medical /ID# 151092
π«π·Plerin, France
Cabinet Medical /ID# 151555
π«π·Prades-le-lez, France
Cabinet Medical /ID# 151093
π«π·Plerin, France
Centre de Consultations /ID# 155458
π«π·St Nazaire, France
Maison de SantΓ© Protestante Bordeaux Bagatelle /ID# 151497
π«π·Talence CEDEX, France
Cabinet Medical /ID# 152841
π«π·Toulouse, France
Duplicate_Hopital Trousseau /ID# 150168
π«π·Tours, France
HCL - HΓ΄pital Lyon Sud /ID# 151505
π«π·Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
CH Henri Duffaut /ID# 151383
π«π·Avignon CEDEX 9, Provence-Alpes-Cote-d Azur, France
Pole Sante Leonard de Vinci /ID# 151384
π«π·Chambray Les Tours, France
Hopital de la Cavale Blanche /ID# 152618
π«π·Brest, France
Geier, Cabinet Medical /ID# 149652
π«π·Brest, France
CH du Haut Anjou /ID# 151151
π«π·Chateau Gontier, France
Cabinet Medical /ID# 151162
π«π·Strasbourg, France
Clinique Ambroise Pare /ID# 161978
π«π·Toulouse, France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 151176
π«π·Paris, France
Centre Medical Alexandre Dumas /Id# 165857
π«π·Amiens, France
Duplicate_HOPITAL DUPUYTREN /ID# 157889
π«π·Limoges, France
Centre Endo Nord Isere /ID# 151390
π«π·Bourgoin Jallieu, France
CH Annecy Genevois Site Annecy /ID# 151131
π«π·PRINGY cedex, Haute-Savoie, France
Duplicate_Hopital Robert Ballanger /ID# 151382
π«π·Aulnay Sous Bois Cedex, France
Centre Hospitalier de la Cote /ID# 163714
π«π·Bayonne, Pyrenees-Atlantiques, France
APHM - Hopital Nord /ID# 152620
π«π·Marseille, Bouches-du-Rhone, France
Hopital Beaujon /ID# 151498
π«π·Clichy, Ile-de-France, France
CH La Rochelle - Hopital Saint Louis /ID# 151182
π«π·La Rochelle, France
Duplicate_CHU LYON SUD /ID# 153801
π«π·Pierre Benite, France
Hopital de la Cavale Blanche /ID# 153608
π«π·Brest, France
CHRU Lille - Hopital Claude Huriez /ID# 151514
π«π·Lille, Hauts-de-France, France
Cabinet Medical /ID# 151391
π«π·Caen, France
Polyclinique du Tondu /ID# 161977
π«π·Bordeaux, France
Centre Medical Les Sources /ID# 151174
π«π·Montigny Les Cormeilles, France
AP-HP - Hopital Saint-Louis /ID# 151509
π«π·Paris, France
Hopital Paris Saint-Joseph /ID# 153526
π«π·Paris, France
Cabinet Medical /ID# 152362
π«π·Paris, France
Cabinet Medical /ID# 151094
π«π·Plerin, France
Cabinet Medical /ID# 150978
π«π·Douarnenez, France
Centre Gastro Loire /ID# 151387
π«π·Gien, France
Cabinet Medical /ID# 151148
π«π·Poissy, France
Cabinet Medical /ID# 151558
π«π·Saverne, France
Centre de Consultations /ID# 151128
π«π·St Nazaire, France
GH Mutualiste Les Portes Du Sud /ID# 152374
π«π·Venissieux, France
CHU d'Amiens /ID# 152651
π«π·Salouel, France
Centre de Consultations /ID# 151164
π«π·St Nazaire, France
Cabinet Medical /ID# 151559
π«π·St Quentin, France
CHU Toulouse - Hopital Rangueil /ID# 157890
π«π·Toulouse, France
GH Mutualiste Les Portes Du Sud /ID# 159231
π«π·Venissieux, France
Centre HΓ©pato-Biliaire - Hopital Paul-Brousse /ID# 151152
π«π·Villejuif, France
Cabinet Medical /ID# 151118
π«π·Paris, France
Cabinet Medical /ID# 150845
π«π·Erstein, France
GHPSO CH Creil /ID# 151117
π«π·Creil, France
Cabinet Medical /ID# 170136
π«π·Toulouse, France
Clinique du Palais /ID# 151175
π«π·Grasse, France
Cabinet Medical, Dr. Constant, /ID# 151119
π«π·Toulon, France
Cabinet Medical /ID# 151557
π«π·Troyes, France
Clinique Pasteur /ID# 155792
π«π·Toulouse CEDEX 3, France
Chu de Nice-Hopital L'Archet Ii /Id# 151132
π«π·Nice, Alpes-Maritimes, France
CHU Clermont-Ferrand /ID# 153527
π«π·Clermont, Auvergne-Rhone-Alpes, France
HCL - HΓ΄pital Lyon Sud /ID# 151146
π«π·Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
Hopital Saint Joseph /ID# 164405
π«π·Marseille, Bouches-du-Rhone, France
HCL - HΓ΄pital Lyon Sud /ID# 165859
π«π·Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
CH Henri Duffaut /ID# 151499
π«π·Avignon CEDEX 9, Provence-Alpes-Cote-d Azur, France
CHRU Tours - Hopital Trousseau /ID# 163503
π«π·Chambray Les Tours, France
CHU Grenoble - Hopital Michallon /ID# 151508
π«π·La Tronche, France
CH Des Deux Vallees Longumeau /ID# 150977
π«π·Longjumeau, France
CHRU Pontchaillou /ID# 166806
π«π·Rennes, France
Centre Medical du Clos de Pacy /ID# 151129
π«π·Sucy En Brie, France
Clinique Pasteur /ID# 151088
π«π·Toulouse CEDEX 3, France
Cabinet Medical /ID# 152617
π«π·Voiron, France
CHU NIMES - Hopital Caremeau /ID# 169178
π«π·Nimes CEDEX 9, Gard, France
Centre Hosp Intercommunal de Creteil /ID# 152361
π«π·Creteil, Val-de-Marne, France
Chu de Nice-Hopital L'Archet Ii /Id# 151181
π«π·Nice, Alpes-Maritimes, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 166807
π«π·St. Priest En Jarez, Loire, France
Centre des consultations spΓ©cialisΓ©es de la sauvegarde /ID# 151515
π«π·Lyon, France