Ulcerative Colitis Clinical Trial
Official title:
Effectiveness of Golimumab in Patients With Ulcerative Colitis: Results of a Real-life Study in Switzerland
Verified date | May 2022 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 the investigators to study, whether patients with ulcerative colitis can be effectively treated with golimumab in a real world setting in Switzerland. The investigators used data from the Swiss IBD cohort study (SIBDC) in Switzerland and identified all SIBDC patients with UC treated with Golimumab and performed a retrospective chart review. The investigators acquired 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 was clinical response (i.e. meaningful improvement) at 6-10 weeks. Secondary endpoints were clinical response at 6 and 12 months and clinical remission (i.e. free of symptoms of disease).
Status | Completed |
Enrollment | 103 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patient of the Swiss IBD cohort study - Diagnosis of ulcerative colitis - Past treatment with golimumab (at least one dose) Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Switzerland | Division of Gastroenterology, University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Merck Sharp & Dohme LLC |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response at week 6-10 | Clinical response at week 6-10 | 6-10 weeks after first golimumab dose | |
Secondary | Response at 6 months | Clinical response at 6 months | 6 months after first golimumab dose | |
Secondary | Response at 12 months | Clinical response at 12 months | 12 months after first golimumab dose | |
Secondary | Remission at week 6-10 | Clinical remission at week 6-10 | 6-10 weeks after first golimumab dose | |
Secondary | Remission at 6 months | Clinical remission at 6 months | 6 months after first golimumab dose | |
Secondary | Remission at 12 months | Clinical remission at 12 months | 12 months after first golimumab dose |
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