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

NCT05405465 | Completed

• 1 other identifier: Golimumab Real-world study
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Ulcerative Colitis; Flare Up, Symptom

Keywords

Golimumab; Ulcerative Colitis; TNF-inhibitors; Clinical Response; Clinical Remission

Outcome Measures

Primary Outcomes (1)

• Response at week 6-10

  Clinical response at week 6-10

  6-10 weeks after first golimumab dose

Secondary Outcomes (5)

• Response at 6 months

  6 months after first golimumab dose

• Response at 12 months

  12 months after first golimumab dose

• Remission at week 6-10

  6-10 weeks after first golimumab dose

• Remission at 6 months

  6 months after first golimumab dose

• Remission at 12 months

  12 months after first golimumab dose

Study Arms (1)

UC patients with exposure to golimumab

The investigators retrospectively analyzed all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab.

Drug: Exposure to golimumab

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.

UC patients with exposure to golimumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the Swiss IBD cohort study with ulcerative colitis treated with golimumab.

You may qualify if:

• Patient of the Swiss IBD cohort study
• Diagnosis of ulcerative colitis
• Past treatment with golimumab (at least one dose)

You may not qualify if:

• none

Sponsors & Collaborators

• University of Zurich: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Division of Gastroenterology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Symptom Flare Up

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 6, 2022
• Study Start: January 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-05

Locations

CH (1)