Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
NCT ID: NCT03394586
Last Updated: 2018-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2018-01-01
2018-12-31
Brief Summary
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The investigators will use data from the Swiss IBD cohort study (SIBDC) in Switzerland. They will identify all SIBDC patients with UC treated with Golimumab and perform a retrospective chart review. The investigators will acquire patient reported outcomes and objective measures for inflammation at baseline, at 6-10 weeks and at 6 and 12 months after golimumab treatment. Primary endpoint will be clinical response (i.e. meaningful improvement) at 6-10 weeks. Secondary endpoints will be clinical response at 6 and 12 months and clinical remission (i.e. free of symptoms of disease).
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Detailed Description
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As clinical response in UC the investigators will define a composite end point of: Marked improvement in partial Mayo score AND improvement in one or more of the following parameters (acquired during chart review):
* Endoscopy data
* ultrasonography
* Calprotectin (cut off 100microg/g)
* CRP
* Anemia resolution
Marked improvement is defined as: Clinical response based on partial Mayo Score (including physician global assessment): decrease in partial Mayo score ≥ 2 points and ≥ 30% from baseline and a decrease in rectal bleeding subscore ≥ 1 point or absolute rectal bleeding score ≤ 1. Improvement in lab work is defined as a reduction of the difference between baseline values and the next limit of normal by ≥ 30%. Improvement in endoscopy/ ultrasonography is defined as a reduction of colitis in the same technique compared to baseline substantiated by images (endoscopy) or measurements of diameter of the bowel wall.
As clinical remission in UC the investigators define normalization (i.e. absence of pathology) of patient reported outcomes (Frequency of stool, blood in stool) AND no evidence of residual disease activity in all of the following parameters:
* endoscopy data
* ultrasonography
* calprotectin (cut off 100microg/g)
* CRP and anemia
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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UC patients with golimumab
We will retrospectively analyze all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab.
Exposure to golimumab
retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.
Interventions
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Exposure to golimumab
retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis ulcerative colitis
* Past treatment with golimumab (at least one dose)
Exclusion Criteria
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Gerhard Rogler, MD PhD
Role: STUDY_CHAIR
University of Zurich
Locations
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Division of Gastroenterology, University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Golimumab study
Identifier Type: -
Identifier Source: org_study_id
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