Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
SOTHIS
1 other identifier
observational
265
1 country
80
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedStudy Start
First participant enrolled
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedDecember 31, 2024
December 1, 2024
7.6 years
April 11, 2016
December 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to loss of clinical benefit
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.
Up to Month 120
Secondary Outcomes (3)
Change from Baseline (Month 0) in Steroid-free remission
From Month 0 to Month 120
Change from Baseline (Month 0) in Clinical Remission
From Month 0 to Month 120
Change from Baseline (Month 0) in Clinical Response
From Month 0 to Month 120
Study Arms (1)
Subjects starting/ receiving adalimumab
Subjects starting/ receiving Adalimumab for UC
Eligibility Criteria
Subjects starting/ receiving Adalimumab for UC
You may qualify if:
- 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
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (80)
Chu de Nice-Hopital L'Archet Ii /Id# 151132
Nice, Alpes-Maritimes, 06200, France
Chu de Nice-Hopital L'Archet Ii /Id# 151181
Nice, Alpes-Maritimes, 06200, France
CHU Clermont-Ferrand /ID# 153527
Clermont, Auvergne-Rhône-Alpes, 63100, France
HCL - Hôpital Lyon Sud /ID# 151146
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
HCL - Hôpital Lyon Sud /ID# 151505
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
HCL - Hôpital Lyon Sud /ID# 165859
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
Hopital Saint Joseph /ID# 164405
Marseille, Bouches-du-Rhone, 13008, France
APHM - Hopital Nord /ID# 152620
Marseille, Bouches-du-Rhone, 13015, France
CHU NIMES - Hopital Caremeau /ID# 169178
Nîmes, Gard, 30029, France
Cabinet Medical /ID# 155460
BAIE Mahault, Guadeloupe, 97122, France
CHU Toulouse - Hopital Purpan /ID# 167179
Toulouse, Haute-Garonne, 31059, France
CH Annecy Genevois Site Annecy /ID# 151131
Pringy, Haute-Savoie, 74374, France
CHRU Lille - Hopital Claude Huriez /ID# 151514
Lille, Hauts-de-France, 59037, France
CHRU Nancy - Hôpitaux de Brabois /ID# 151147
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 166807
Saint Priest EN Jarez, Pays de la Loire Region, 42270, France
CH Henri Duffaut /ID# 151383
Avignon, Provence-Alpes-Côte d'Azur Region, 84902, France
CH Henri Duffaut /ID# 151499
Avignon, Provence-Alpes-Côte d'Azur Region, 84902, France
Centre Hospitalier de la Cote /ID# 163714
Bayonne, Pyrenees-Atlantiques, 64100, France
Centre Hosp Intercommunal de Creteil /ID# 152361
Créteil, Val-de-Marne, 94000, France
Centre Medical Alexandre Dumas /Id# 165857
Amiens, 80090, France
Duplicate_Hopital Robert Ballanger /ID# 151382
Aulnay-sous-Bois, 93602, France
Polyclinique du Tondu /ID# 161977
Bordeaux, 33082, France
Centre Endo Nord Isere /ID# 151390
Bourgoin, 38300, France
Geier, Cabinet Medical /ID# 149652
Brest, 29200, France
Hopital de la Cavale Blanche /ID# 152618
Brest, 29200, France
Hopital de la Cavale Blanche /ID# 153608
Brest, 29200, France
Cabinet Medical /ID# 151391
Caen, 14050, France
CHRU Tours - Hopital Trousseau /ID# 163503
Chambray-lès-Tours, 37170, France
Pole Sante Leonard de Vinci /ID# 151384
Chambray-lès-Tours, 37175, France
Ch Chauny /Id# 151149
Chauny, 02303, France
CH du Haut Anjou /ID# 151151
Château-Gontier, 53204, France
Hopital Louis Mourier,Colombes /ID# 152650
Colombe, 92701, France
GHPSO CH Creil /ID# 151117
Creil, 60109, France
Cabinet Medical /ID# 150978
Douarnenez, 29100, France
Cabinet Medical /ID# 150845
Erstein, 67150, France
Centre Gastro Loire /ID# 151387
Gien, 45500, France
Clinique du Palais /ID# 151175
Grasse, 06130, France
CH La Rochelle - Hopital Saint Louis /ID# 151182
La Rochelle, 17019, France
CHU Grenoble - Hopital Michallon /ID# 151508
La Tronche, 38700, France
Duplicate_HOPITAL DUPUYTREN /ID# 157889
Limoges, 87042, France
CH Des Deux Vallees Longumeau /ID# 150977
Longjumeau, 91161, France
HCL - Hopital Edouard Herriot /ID# 151513
Lyon, 69003, France
Centre des consultations spécialisées de la sauvegarde /ID# 151515
Lyon, 69338, France
Centre Medical Les Sources /ID# 151174
Montigny-lès-Cormeilles, 95370, France
AP-HP - Hopital Saint-Louis /ID# 151509
Paris, 75010, France
Hopital Paris Saint-Joseph /ID# 153526
Paris, 75014, France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 151176
Paris, 75018, France
Cabinet Medical /ID# 151118
Paris, 75020, France
Cabinet Medical /ID# 152362
Paris, 75020, France
Duplicate_CHU LYON SUD /ID# 153801
Pierre-Bénite, 69495, France
Cabinet Medical /ID# 151092
Plérin, 22198, France
Cabinet Medical /ID# 151093
Plérin, 22198, France
Cabinet Medical /ID# 151094
Plérin, 22198, France
Cabinet Medical /ID# 151148
Poissy, 78300, France
Cabinet Medical /ID# 151555
Prades-le-Lez, 34730, France
CHRU Pontchaillou /ID# 166806
Rennes, 35033, France
CHU La Réunion - site St Denis - Félix-Guyon /ID# 151556
Saint-Denis, 97405, France
Centre de Consultations /ID# 151128
Saint-Nazaire, 44606, France
Centre de Consultations /ID# 151164
Saint-Nazaire, 44606, France
Centre de Consultations /ID# 155458
Saint-Nazaire, 44606, France
Cabinet Medical /ID# 151559
Saint-Quentin, 02100, France
CHU d'Amiens /ID# 152651
Salouël, 80480, France
Cabinet Medical /ID# 151558
Saverne, 67700, France
Cabinet Medical /ID# 151162
Strasbourg, 67000, France
Centre Medical du Clos de Pacy /ID# 151129
Sucy-en-Brie, 94370, France
Maison de Santé Protestante Bordeaux Bagatelle /ID# 151497
Talence, 33401, France
Cabinet Medical, Dr. Constant, /ID# 151119
Toulon, 83000, France
Clinique Pasteur /ID# 151088
Toulouse, 31076, France
Clinique Pasteur /ID# 155792
Toulouse, 31076, France
Clinique Ambroise Pare /ID# 161978
Toulouse, 31100, France
Cabinet Medical /ID# 170136
Toulouse, 31300, France
Cabinet Medical /ID# 152841
Toulouse, 31400, France
CHU Toulouse - Hopital Rangueil /ID# 157890
Toulouse, 31400, France
Duplicate_Hopital Trousseau /ID# 150168
Tours, 37044, France
Cabinet Medical /ID# 151557
Troyes, 10000, France
GH Mutualiste Les Portes Du Sud /ID# 152374
Vénissieux, 69200, France
GH Mutualiste Les Portes Du Sud /ID# 159231
Vénissieux, 69200, France
Centre Hépato-Biliaire - Hopital Paul-Brousse /ID# 151152
Villejuif, 94800, France
Cabinet Medical /ID# 152617
Voiron, 38500, France
Hopital Beaujon /ID# 151498
Clichy, Île-de-France Region, 92110, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2016
First Posted
April 14, 2016
Study Start
April 29, 2016
Primary Completion
December 15, 2023
Study Completion
December 15, 2023
Last Updated
December 31, 2024
Record last verified: 2024-12