- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394586
Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
TNF inhibitors have improved treatment options for patients with inflammatory bowel disease (IBD) and three TNF inhibitors, infliximab, adalimumab and golimumab are available for treatment of ulcerative colitis in Switzerland. However, these drugs have been tested under ideal conditions in randomized controlled trials. Real-world data are needed to complement this information. It is the aim of our study to test, whether patients with ulcerative colitis can be effectively treated with golimumab in a real world setting in Switzerland.
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab will be identified. The investigators will perform a retrospective chart review and assess patient reported outcomes and objective measures of inflammation to assess response and remission.
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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Benjamin Misselwitz, MD
- Phone Number: 0041 044 255 1111
- Email: benjamin.misselwitz@usz.ch
Study Locations
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Zurich, Switzerland, 8091
- Recruiting
- Division of Gastroenterology, University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient of the Swiss IBD cohort study
- Diagnosis ulcerative colitis
- Past treatment with golimumab (at least one dose)
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
UC patients with golimumab
We will retrospectively analyze all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab.
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retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response at week 6-10
Time Frame: 6-10 weeks after first golimumab dose
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Clinical response at week 6-10
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6-10 weeks after first golimumab dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response at 6 months
Time Frame: 6 months after first golimumab dose
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Clinical response at 6 months
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6 months after first golimumab dose
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Response at 12 months
Time Frame: 12 months after first golimumab dose
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Clinical response at 12 months
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12 months after first golimumab dose
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Remission at week 6-10
Time Frame: 6-10 weeks after first golimumab dose
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Clinical remission at week 6-10
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6-10 weeks after first golimumab dose
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Remission at 6 months
Time Frame: 12 months after first golimumab dose
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Clinical remission at 6 months
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12 months after first golimumab dose
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Remission at 12 months
Time Frame: 12 months after first golimumab dose
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Clinical remission at 12 months
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12 months after first golimumab dose
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease Attributes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Recurrence
- Ulcer
- Colitis
- Colitis, Ulcerative
- Symptom Flare Up
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tumor Necrosis Factor Inhibitors
- Golimumab
Other Study ID Numbers
- Golimumab study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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