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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02738125

Acronym

SOTHIS

Enrollment

265

Registered

2016-04-14

Start date

2016-04-29

Completion date

2023-12-15

Last updated

2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis (UC)

Keywords

Adalimumab, Ulcerative Colitis, SOTHIS, Effectiveness

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results