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