Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions (SOTHIS)

June 27, 2023 updated by: AbbVie
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80090
        • Centre Medical Alexandre Dumas /Id# 165857
      • Aulnay Sous Bois Cedex, France, 93602
        • Duplicate_Hopital Robert Ballanger /ID# 151382
      • Bordeaux, France, 33082
        • Polyclinique du Tondu /ID# 161977
      • Bourgoin Jallieu, France, 38300
        • Centre Endo Nord Isere /ID# 151390
      • Brest, France, 29200
        • Geier, Cabinet Medical /ID# 149652
      • Brest, France, 29200
        • Hopital de la Cavale Blanche /ID# 152618
      • Brest, France, 29200
        • Hopital de la Cavale Blanche /ID# 153608
      • Caen, France, 14050
        • Cabinet Medical /ID# 151391
      • Chambray Les Tours, France, 37170
        • CHRU Tours - Hopital Trousseau /ID# 163503
      • Chambray Les Tours, France, 37175
        • Pole Sante Leonard de Vinci /ID# 151384
      • Chateau Gontier, France, 53204
        • CH du Haut Anjou /ID# 151151
      • Chauny, France, 02303
        • Ch Chauny /Id# 151149
      • Colombe, France, 92701
        • Hopital Louis Mourier,Colombes /ID# 152650
      • Creil, France, 60109
        • GHPSO CH Creil /ID# 151117
      • Douarnenez, France, 29100
        • Cabinet Medical /ID# 150978
      • Erstein, France, 67150
        • Cabinet Medical /ID# 150845
      • Gien, France, 45500
        • Centre Gastro Loire /ID# 151387
      • Grasse, France, 06130
        • Clinique du Palais /ID# 151175
      • La Rochelle, France, 17019
        • CH La Rochelle - Hopital Saint Louis /ID# 151182
      • La Tronche, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 151508
      • Limoges, France, 87042
        • Duplicate_HOPITAL DUPUYTREN /ID# 157889
      • Longjumeau, France, 91161
        • CH Des Deux Vallees Longumeau /ID# 150977
      • Lyon, France, 69003
        • HCL - Hopital Edouard Herriot /ID# 151513
      • Lyon, France, 69338
        • Centre des consultations spécialisées de la sauvegarde /ID# 151515
      • Montigny Les Cormeilles, France, 95370
        • Centre Medical Les Sources /ID# 151174
      • Paris, France, 75010
        • AP-HP - Hopital Saint-Louis /ID# 151509
      • Paris, France, 75014
        • Hopital Paris Saint-Joseph /ID# 153526
      • Paris, France, 75018
        • AP-HP - Hopital Bichat - Claude-Bernard /ID# 151176
      • Paris, France, 75020
        • Cabinet Medical /ID# 151118
      • Paris, France, 75020
        • Cabinet Medical /ID# 152362
      • Pierre Benite, France, 69495
        • Duplicate_CHU LYON SUD /ID# 153801
      • Plerin, France, 22198
        • Cabinet Medical /ID# 151092
      • Plerin, France, 22198
        • Cabinet Medical /ID# 151093
      • Plerin, France, 22198
        • Cabinet Medical /ID# 151094
      • Poissy, France, 78300
        • Cabinet Medical /ID# 151148
      • Prades-le-lez, France, 34730
        • Cabinet Medical /ID# 151555
      • Rennes, France, 35033
        • CHRU Pontchaillou /ID# 166806
      • Saint-Denis, France, 97405
        • CHU La Réunion - site St Denis - Félix-Guyon /ID# 151556
      • Salouel, France, 80480
        • CHU d'Amiens /ID# 152651
      • Saverne, France, 67700
        • Cabinet Medical /ID# 151558
      • St Nazaire, France, 44606
        • Centre de Consultations /ID# 151128
      • St Nazaire, France, 44606
        • Centre de Consultations /ID# 151164
      • St Nazaire, France, 44606
        • Centre de Consultations /ID# 155458
      • St Quentin, France, 02100
        • Cabinet Medical /ID# 151559
      • Strasbourg, France, 67000
        • Cabinet Medical /ID# 151162
      • Sucy En Brie, France, 94370
        • Centre Medical du Clos de Pacy /ID# 151129
      • Talence CEDEX, France, 33401
        • Maison de Santé Protestante Bordeaux Bagatelle /ID# 151497
      • Toulon, France, 83000
        • Cabinet Medical, Dr. Constant, /ID# 151119
      • Toulouse, France, 31100
        • Clinique Ambroise Pare /ID# 161978
      • Toulouse, France, 31300
        • Cabinet Medical /ID# 170136
      • Toulouse, France, 31400
        • Cabinet Medical /ID# 152841
      • Toulouse, France, 31400
        • CHU Toulouse - Hopital Rangueil /ID# 157890
      • Toulouse CEDEX 3, France, 31076
        • Clinique Pasteur /ID# 151088
      • Toulouse CEDEX 3, France, 31076
        • Clinique Pasteur /ID# 155792
      • Tours, France, 37044
        • Duplicate_Hopital Trousseau /ID# 150168
      • Troyes, France, 10000
        • Cabinet Medical /ID# 151557
      • Venissieux, France, 69200
        • GH Mutualiste Les Portes Du Sud /ID# 152374
      • Venissieux, France, 69200
        • GH Mutualiste Les Portes Du Sud /ID# 159231
      • Villejuif, France, 94800
        • Centre Hépato-Biliaire - Hopital Paul-Brousse /ID# 151152
      • Voiron, France, 38500
        • Cabinet Medical /ID# 152617
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Chu de Nice-Hopital L'Archet Ii /Id# 151132
      • Nice, Alpes-Maritimes, France, 06200
        • Chu de Nice-Hopital L'Archet Ii /Id# 151181
    • Auvergne-Rhone-Alpes
      • Clermont, Auvergne-Rhone-Alpes, France, 63100
        • CHU Clermont-Ferrand /ID# 153527
      • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
        • HCL - Hôpital Lyon Sud /ID# 151146
      • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
        • HCL - Hôpital Lyon Sud /ID# 151505
      • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
        • HCL - Hôpital Lyon Sud /ID# 165859
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13008
        • Hopital Saint Joseph /ID# 164405
      • Marseille, Bouches-du-Rhone, France, 13015
        • APHM - Hopital Nord /ID# 152620
    • Gard
      • Nimes CEDEX 9, Gard, France, 30029
        • CHU NIMES - Hopital Caremeau /ID# 169178
    • Guadeloupe
      • BAIE Mahault, Guadeloupe, France, 97122
        • Cabinet Medical /ID# 155460
    • Haute-Garonne
      • TOULOUSE Cedex 9, Haute-Garonne, France, 31059
        • CHU Toulouse - Hopital Purpan /ID# 167179
    • Haute-Savoie
      • PRINGY cedex, Haute-Savoie, France, 74374
        • CH Annecy Genevois Site Annecy /ID# 151131
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • CHRU Lille - Hopital Claude Huriez /ID# 151514
    • Ile-de-France
      • Clichy, Ile-de-France, France, 92110
        • Hopital Beaujon /ID# 151498
    • Loire
      • St. Priest En Jarez, Loire, France, 42270
        • CHU de SAINT ETIENNE - Hopital Nord /ID# 166807
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54500
        • CHRU Nancy - Hôpitaux de Brabois /ID# 151147
    • Provence-Alpes-Cote-d Azur
      • Avignon CEDEX 9, Provence-Alpes-Cote-d Azur, France, 84902
        • CH Henri Duffaut /ID# 151383
      • Avignon CEDEX 9, Provence-Alpes-Cote-d Azur, France, 84902
        • CH Henri Duffaut /ID# 151499
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64100
        • Centre Hospitalier de la Cote /ID# 163714
    • Val-de-Marne
      • Creteil, Val-de-Marne, France, 94000
        • Centre Hosp Intercommunal de Creteil /ID# 152361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects starting/ receiving Adalimumab for UC

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects starting/ receiving adalimumab
Subjects starting/ receiving Adalimumab for UC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to loss of clinical benefit
Time Frame: 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.
Up to Month 120

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline (Month 0) in Steroid-free remission
Time Frame: 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.
From Month 0 to Month 120
Change from Baseline (Month 0) in Clinical Remission
Time Frame: From Month 0 to Month 120
Clinical remission is defined as partial Mayo score <= 2 with no subscore >1
From Month 0 to Month 120
Change from Baseline (Month 0) in Clinical Response
Time Frame: 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.
From Month 0 to Month 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2016

Primary Completion (Estimated)

April 29, 2029

Study Completion (Estimated)

April 29, 2029

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimated)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-681

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis (UC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe