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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05405465
• Other study ID #: Golimumab Real-world study
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab were identified. The investigators performed a retrospective chart review and assessed patient reported outcomes and objective measures of inflammation to assess response and remission.

As clinical response in UC the investigators defined a composite end point of: Marked improvement in partial Mayo score AND improvement in one or more of the following parameters (acquired during chart review):

• Endoscopy data

• Ultrasonography

• Calprotectin (cut off 100microg/g)

• CRP

• Anemia resolution

Marked improvement was defined as: Clinical response based on partial Mayo Score (including physician global assessment): decrease in partial Mayo score ≥ 2 points and ≥ 30% from baseline and a decrease in rectal bleeding subscore ≥ 1 point or absolute rectal bleeding score ≤ 1. Improvement in lab work was defined as a reduction of the difference between baseline values and the next limit of normal by ≥ 30%. Improvement in endoscopy/ ultrasonography was defined as a reduction of colitis in the same technique compared to baseline substantiated by images (endoscopy) or measurements of diameter of the bowel wall.

As clinical remission in UC we defined normalization (i.e. absence of pathology) of patient reported outcomes (Frequency of stool, blood in stool) AND no evidence of residual disease activity in all of the following parameters:

• Endoscopy data

• Ultrasonography

• Calprotectin (cut off 100microg/g)

• CRP and anemia

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Flare Up, Symptom
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Switzerland	Division of Gastroenterology, University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Switzerland, 

Outcome

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