Ulcerative Colitis (UC) Clinical Trial
— SOTHISOfficial title:
Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
| NCT number | NCT02738125 |
| Other study ID # | P15-681 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 29, 2016 |
| Est. completion date | December 15, 2023 |
| Verified date | June 2024 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 265 |
| Est. completion date | December 15, 2023 |
| Est. primary completion date | December 15, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Medical Alexandre Dumas /Id# 165857 | Amiens | |
| France | Duplicate_Hopital Robert Ballanger /ID# 151382 | Aulnay Sous Bois Cedex | |
| France | CH Henri Duffaut /ID# 151383 | Avignon CEDEX 9 | Provence-Alpes-Cote-d Azur |
| France | CH Henri Duffaut /ID# 151499 | Avignon CEDEX 9 | Provence-Alpes-Cote-d Azur |
| France | Cabinet Medical /ID# 155460 | BAIE Mahault | Guadeloupe |
| France | Centre Hospitalier de la Cote /ID# 163714 | Bayonne | Pyrenees-Atlantiques |
| France | Polyclinique du Tondu /ID# 161977 | Bordeaux | |
| France | Centre Endo Nord Isere /ID# 151390 | Bourgoin Jallieu | |
| France | Geier, Cabinet Medical /ID# 149652 | Brest | |
| France | Hopital de la Cavale Blanche /ID# 152618 | Brest | |
| France | Hopital de la Cavale Blanche /ID# 153608 | Brest | |
| France | Cabinet Medical /ID# 151391 | Caen | |
| France | CHRU Tours - Hopital Trousseau /ID# 163503 | Chambray Les Tours | |
| France | Pole Sante Leonard de Vinci /ID# 151384 | Chambray Les Tours | |
| France | CH du Haut Anjou /ID# 151151 | Chateau Gontier | |
| France | Ch Chauny /Id# 151149 | Chauny | |
| France | CHU Clermont-Ferrand /ID# 153527 | Clermont | Auvergne-Rhone-Alpes |
| France | Hopital Beaujon /ID# 151498 | Clichy | Ile-de-France |
| France | Hopital Louis Mourier,Colombes /ID# 152650 | Colombe | |
| France | GHPSO CH Creil /ID# 151117 | Creil | |
| France | Centre Hosp Intercommunal de Creteil /ID# 152361 | Creteil | Val-de-Marne |
| France | Cabinet Medical /ID# 150978 | Douarnenez | |
| France | Cabinet Medical /ID# 150845 | Erstein | |
| France | Centre Gastro Loire /ID# 151387 | Gien | |
| France | Clinique du Palais /ID# 151175 | Grasse | |
| France | CH La Rochelle - Hopital Saint Louis /ID# 151182 | La Rochelle | |
| France | CHU Grenoble - Hopital Michallon /ID# 151508 | La Tronche | |
| France | CHRU Lille - Hopital Claude Huriez /ID# 151514 | Lille | Hauts-de-France |
| France | Duplicate_HOPITAL DUPUYTREN /ID# 157889 | Limoges | |
| France | CH Des Deux Vallees Longumeau /ID# 150977 | Longjumeau | |
| France | Centre des consultations spécialisées de la sauvegarde /ID# 151515 | Lyon | |
| France | HCL - Hopital Edouard Herriot /ID# 151513 | Lyon | |
| France | APHM - Hopital Nord /ID# 152620 | Marseille | Bouches-du-Rhone |
| France | Hopital Saint Joseph /ID# 164405 | Marseille | Bouches-du-Rhone |
| France | Centre Medical Les Sources /ID# 151174 | Montigny Les Cormeilles | |
| France | Chu de Nice-Hopital L'Archet Ii /Id# 151132 | Nice | Alpes-Maritimes |
| France | Chu de Nice-Hopital L'Archet Ii /Id# 151181 | Nice | Alpes-Maritimes |
| France | CHU NIMES - Hopital Caremeau /ID# 169178 | Nimes CEDEX 9 | Gard |
| France | AP-HP - Hopital Bichat - Claude-Bernard /ID# 151176 | Paris | |
| France | AP-HP - Hopital Saint-Louis /ID# 151509 | Paris | |
| France | Cabinet Medical /ID# 151118 | Paris | |
| France | Cabinet Medical /ID# 152362 | Paris | |
| France | Hopital Paris Saint-Joseph /ID# 153526 | Paris | |
| France | Duplicate_CHU LYON SUD /ID# 153801 | Pierre Benite | |
| France | HCL - Hôpital Lyon Sud /ID# 151146 | Pierre Benite CEDEX | Auvergne-Rhone-Alpes |
| France | HCL - Hôpital Lyon Sud /ID# 151505 | Pierre Benite CEDEX | Auvergne-Rhone-Alpes |
| France | HCL - Hôpital Lyon Sud /ID# 165859 | Pierre Benite CEDEX | Auvergne-Rhone-Alpes |
| France | Cabinet Medical /ID# 151092 | Plerin | |
| France | Cabinet Medical /ID# 151093 | Plerin | |
| France | Cabinet Medical /ID# 151094 | Plerin | |
| France | Cabinet Medical /ID# 151148 | Poissy | |
| France | Cabinet Medical /ID# 151555 | Prades-le-lez | |
| France | CH Annecy Genevois Site Annecy /ID# 151131 | PRINGY cedex | Haute-Savoie |
| France | CHRU Pontchaillou /ID# 166806 | Rennes | |
| France | CHU La Réunion - site St Denis - Félix-Guyon /ID# 151556 | Saint-Denis | |
| France | CHU d'Amiens /ID# 152651 | Salouel | |
| France | Cabinet Medical /ID# 151558 | Saverne | |
| France | Centre de Consultations /ID# 151128 | St Nazaire | |
| France | Centre de Consultations /ID# 151164 | St Nazaire | |
| France | Centre de Consultations /ID# 155458 | St Nazaire | |
| France | Cabinet Medical /ID# 151559 | St Quentin | |
| France | CHU de SAINT ETIENNE - Hopital Nord /ID# 166807 | St. Priest En Jarez | Loire |
| France | Cabinet Medical /ID# 151162 | Strasbourg | |
| France | Centre Medical du Clos de Pacy /ID# 151129 | Sucy En Brie | |
| France | Maison de Santé Protestante Bordeaux Bagatelle /ID# 151497 | Talence CEDEX | |
| France | Cabinet Medical, Dr. Constant, /ID# 151119 | Toulon | |
| France | Cabinet Medical /ID# 152841 | Toulouse | |
| France | Cabinet Medical /ID# 170136 | Toulouse | |
| France | CHU Toulouse - Hopital Rangueil /ID# 157890 | Toulouse | |
| France | Clinique Ambroise Pare /ID# 161978 | Toulouse | |
| France | Clinique Pasteur /ID# 151088 | Toulouse CEDEX 3 | |
| France | Clinique Pasteur /ID# 155792 | Toulouse CEDEX 3 | |
| France | CHU Toulouse - Hopital Purpan /ID# 167179 | TOULOUSE Cedex 9 | Haute-Garonne |
| France | Duplicate_Hopital Trousseau /ID# 150168 | Tours | |
| France | Cabinet Medical /ID# 151557 | Troyes | |
| France | CHRU Nancy - Hôpitaux de Brabois /ID# 151147 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle |
| France | GH Mutualiste Les Portes Du Sud /ID# 152374 | Venissieux | |
| France | GH Mutualiste Les Portes Du Sud /ID# 159231 | Venissieux | |
| France | Centre Hépato-Biliaire - Hopital Paul-Brousse /ID# 151152 | Villejuif | |
| France | Cabinet Medical /ID# 152617 | Voiron |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Change from Baseline (Month 0) in Steroid-free remission | Steroid- free remission is defined as partial Mayo score <= 2 with no subscore >1 and no daily intake of prednisone. | From Month 0 to Month 120 | |
| Secondary | Change from Baseline (Month 0) in Clinical Remission | Clinical remission is defined as partial Mayo score <= 2 with no subscore >1 | From Month 0 to Month 120 | |
| Secondary | Change from Baseline (Month 0) in Clinical Response | 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. | From Month 0 to Month 120 |
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