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

Completed

• 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

Study Timeline

• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-14
• Study Start: 2016-04-29
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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 & 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 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 Clermont-Ferrand /ID# 153527; 🇫🇷 Clermont, Auvergne-Rhone-Alpes, 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

Hopital Saint Joseph /ID# 164405; 🇫🇷 Marseille, Bouches-du-Rhone, France

APHM - Hopital Nord /ID# 152620; 🇫🇷 Marseille, Bouches-du-Rhone, France

CHU NIMES - Hopital Caremeau /ID# 169178; 🇫🇷 Nimes CEDEX 9, Gard, France

Cabinet Medical /ID# 155460; 🇫🇷 BAIE Mahault, Guadeloupe, France

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