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Completed

NCT Number: NCT02738125

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

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.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Nice-Hopital L'Archet Ii /Id# 151132, Nice, Alpes-Maritimes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Acronym: SOTHIS

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2016
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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