Effectiveness of Golimumab in Patients With Ulcerative Colitis: Results of a Real-life Study in Switzerland

Sponsor
University of Zurich
Study ID
NCT05405465
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exposure to golimumab — DRUG
    Retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.

Study Details

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).

Key Dates

Start date
Jan 1, 2018
Status verified
May 2022
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021

Study Design

Enrollment
103 participants (actual)

Arms

  • Arm: UC patients with exposure to golimumab
    The investigators retrospectively analyzed all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab.

Primary Outcome Measure

Response at week 6-10 [ Time Frame: 6-10 weeks after first golimumab dose ]

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