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Ulcerative Colitis (UC)SOTHISNCT02738125

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

An observational study of Ulcerative Colitis (UC), run by AbbVie at 80 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Ulcerative Colitis (UC)
How many people
265 participants
Where
80 sitesFrance
Study dates
29 Apr 2016to 15 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects starting/ receiving Adalimumab for UC

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

80 sites in 1 country.

80 sites in 1 country

France80 sites

  • Centre Medical Alexandre Dumas /Id# 165857

    Amiens, 80090

  • Duplicate_Hopital Robert Ballanger /ID# 151382

    Aulnay-sous-Bois, 93602

  • CH Henri Duffaut /ID# 151383

    Avignon, Provence-Alpes-Côte d'Azur Region, 84902

  • CH Henri Duffaut /ID# 151499

    Avignon, Provence-Alpes-Côte d'Azur Region, 84902

  • Cabinet Medical /ID# 155460

    BAIE Mahault, Guadeloupe, 97122

  • Centre Hospitalier de la Cote /ID# 163714

    Bayonne, Pyrenees-Atlantiques, 64100

  • Polyclinique du Tondu /ID# 161977

    Bordeaux, 33082

  • Centre Endo Nord Isere /ID# 151390

    Bourgoin, 38300

  • Geier, Cabinet Medical /ID# 149652

    Brest, 29200

  • Hopital de la Cavale Blanche /ID# 152618

    Brest, 29200

  • Hopital de la Cavale Blanche /ID# 153608

    Brest, 29200

  • Cabinet Medical /ID# 151391

    Caen, 14050

  • CHRU Tours - Hopital Trousseau /ID# 163503

    Chambray-lès-Tours, 37170

  • Pole Sante Leonard de Vinci /ID# 151384

    Chambray-lès-Tours, 37175

  • CH du Haut Anjou /ID# 151151

    Château-Gontier, 53204

  • Ch Chauny /Id# 151149

    Chauny, 02303

  • CHU Clermont-Ferrand /ID# 153527

    Clermont, Auvergne-Rhône-Alpes, 63100

  • Hopital Beaujon /ID# 151498

    Clichy, Île-de-France Region, 92110

  • Hopital Louis Mourier,Colombes /ID# 152650

    Colombe, 92701

  • GHPSO CH Creil /ID# 151117

    Creil, 60109

  • Centre Hosp Intercommunal de Creteil /ID# 152361

    Créteil, Val-de-Marne, 94000

  • Cabinet Medical /ID# 150978

    Douarnenez, 29100

  • Cabinet Medical /ID# 150845

    Erstein, 67150

  • Centre Gastro Loire /ID# 151387

    Gien, 45500

  • Clinique du Palais /ID# 151175

    Grasse, 06130

  • CH La Rochelle - Hopital Saint Louis /ID# 151182

    La Rochelle, 17019

  • CHU Grenoble - Hopital Michallon /ID# 151508

    La Tronche, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 151514

    Lille, Hauts-de-France, 59037

  • Duplicate_HOPITAL DUPUYTREN /ID# 157889

    Limoges, 87042

  • CH Des Deux Vallees Longumeau /ID# 150977

    Longjumeau, 91161

  • HCL - Hopital Edouard Herriot /ID# 151513

    Lyon, 69003

  • Centre des consultations spécialisées de la sauvegarde /ID# 151515

    Lyon, 69338

  • Hopital Saint Joseph /ID# 164405

    Marseille, Bouches-du-Rhone, 13008

  • APHM - Hopital Nord /ID# 152620

    Marseille, Bouches-du-Rhone, 13015

  • Centre Medical Les Sources /ID# 151174

    Montigny-lès-Cormeilles, 95370

  • Chu de Nice-Hopital L'Archet Ii /Id# 151132

    Nice, Alpes-Maritimes, 06200

  • Chu de Nice-Hopital L'Archet Ii /Id# 151181

    Nice, Alpes-Maritimes, 06200

  • CHU NIMES - Hopital Caremeau /ID# 169178

    Nîmes, Gard, 30029

  • AP-HP - Hopital Saint-Louis /ID# 151509

    Paris, 75010

  • Hopital Paris Saint-Joseph /ID# 153526

    Paris, 75014

  • AP-HP - Hopital Bichat - Claude-Bernard /ID# 151176

    Paris, 75018

  • Cabinet Medical /ID# 151118

    Paris, 75020

  • Cabinet Medical /ID# 152362

    Paris, 75020

  • HCL - Hôpital Lyon Sud /ID# 151146

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • HCL - Hôpital Lyon Sud /ID# 151505

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • HCL - Hôpital Lyon Sud /ID# 165859

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Duplicate_CHU LYON SUD /ID# 153801

    Pierre-Bénite, 69495

  • Cabinet Medical /ID# 151092

    Plérin, 22198

  • Cabinet Medical /ID# 151093

    Plérin, 22198

  • Cabinet Medical /ID# 151094

    Plérin, 22198

  • Cabinet Medical /ID# 151148

    Poissy, 78300

  • Cabinet Medical /ID# 151555

    Prades-le-Lez, 34730

  • CH Annecy Genevois Site Annecy /ID# 151131

    Pringy, Haute-Savoie, 74374

  • CHRU Pontchaillou /ID# 166806

    Rennes, 35033

  • CHU de SAINT ETIENNE - Hopital Nord /ID# 166807

    Saint Priest EN Jarez, Pays de la Loire Region, 42270

  • CHU La Réunion - site St Denis - Félix-Guyon /ID# 151556

    Saint-Denis, 97405

  • Centre de Consultations /ID# 151128

    Saint-Nazaire, 44606

  • Centre de Consultations /ID# 151164

    Saint-Nazaire, 44606

  • Centre de Consultations /ID# 155458

    Saint-Nazaire, 44606

  • Cabinet Medical /ID# 151559

    Saint-Quentin, 02100

  • CHU d'Amiens /ID# 152651

    Salouël, 80480

  • Cabinet Medical /ID# 151558

    Saverne, 67700

  • Cabinet Medical /ID# 151162

    Strasbourg, 67000

  • Centre Medical du Clos de Pacy /ID# 151129

    Sucy-en-Brie, 94370

  • Maison de Santé Protestante Bordeaux Bagatelle /ID# 151497

    Talence, 33401

  • Cabinet Medical, Dr. Constant, /ID# 151119

    Toulon, 83000

  • CHU Toulouse - Hopital Purpan /ID# 167179

    Toulouse, Haute-Garonne, 31059

  • Clinique Pasteur /ID# 151088

    Toulouse, 31076

  • Clinique Pasteur /ID# 155792

    Toulouse, 31076

  • Clinique Ambroise Pare /ID# 161978

    Toulouse, 31100

  • Cabinet Medical /ID# 170136

    Toulouse, 31300

  • Cabinet Medical /ID# 152841

    Toulouse, 31400

  • CHU Toulouse - Hopital Rangueil /ID# 157890

    Toulouse, 31400

  • Duplicate_Hopital Trousseau /ID# 150168

    Tours, 37044

  • Cabinet Medical /ID# 151557

    Troyes, 10000

  • CHRU Nancy - Hôpitaux de Brabois /ID# 151147

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

  • GH Mutualiste Les Portes Du Sud /ID# 152374

    Vénissieux, 69200

  • GH Mutualiste Les Portes Du Sud /ID# 159231

    Vénissieux, 69200

  • Centre Hépato-Biliaire - Hopital Paul-Brousse /ID# 151152

    Villejuif, 94800

  • Cabinet Medical /ID# 152617

    Voiron, 38500

Other trials in France

About this study

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.

Keywords
Adalimumab, Ulcerative Colitis, SOTHIS, Effectiveness
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02738125
Study groupRoleWhat they receive
Subjects starting/ receiving adalimumabSubjects starting/ receiving Adalimumab for UC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to Month 120

Secondary outcomes (3)

  1. 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.

    Measured: From Month 0 to Month 120

  2. Change from Baseline (Month 0) in Clinical Remission

    Clinical remission is defined as partial Mayo score <= 2 with no subscore >1

    Measured: From Month 0 to Month 120

  3. 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.

    Measured: From Month 0 to Month 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study start29 Apr 2016
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738125
Sponsor's protocol ID
P15-681
Acronym
SOTHIS
Status last verified
Dec 2024
First submitted
11 Apr 2016
Last updated
31 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis (UC), run by AbbVie at 80 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to loss of clinical benefit (time frame: Up to Month 120). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.

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