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NCT03394586

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

Status unknown Last updated 9 January 2018
What this trial tests

trial testing Exposure to golimumab in Ulcerative Colitis in 100 participants. Status unknown.

Timeline
1 January 2018
Primary endpoint
31 December 2018
31 December 2018

Quick facts

Lead sponsorUniversity of Zurich
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date1 January 2018
Primary completion31 December 2018
Estimated completion31 December 2018
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University of Zurich

Who can join

Eligibility, any sex, with Ulcerative Colitis or Flare Up, Symptom. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Exposure to golimumab

Trials testing the same drug.

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

Other University of Zurich trials

Trials by the same sponsor.

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Data sources for this page

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