Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab

Sponsor
University of Zurich
Study ID
NCT03394586
Status
Unknown

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 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).

Key Dates

Start date
Jan 1, 2018
Status verified
Jan 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: UC patients with golimumab
    We will retrospectively analyze 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 ]

Central Contacts

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