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

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ClinicalTrials.gov Identifier: NCT02738125
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Ulcerative Colitis (UC)

Study Type : Observational
Estimated Enrollment : 540 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
Actual Study Start Date : April 29, 2016
Estimated Primary Completion Date : November 20, 2028
Estimated Study Completion Date : November 20, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects starting/ receiving Adalimumab for UC
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738125


Contacts
Contact: Romain Fardellone romain.fardellone@abbvie.com
Contact: Peggy Schmitt peggy.schmitt@abbvie.com

  Show 81 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02738125     History of Changes
Other Study ID Numbers: P15-681
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie:
Adalimumab
Ulcerative Colitis
SOTHIS
Effectiveness

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents