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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03394586
• Other study ID #: Golimumab study
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2017
• Last updated: January 8, 2018
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: University of Zurich
• Contact: Benjamin Misselwitz, MD
• Phone: 0041 044 255 1111
• Email: benjamin.misselwitz[@]usz.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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 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).

Description:

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

As clinical response in UC the investigators will define 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 is 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 is defined as a reduction of the difference between baseline values and the next limit of normal by ≥ 30%. Improvement in endoscopy/ ultrasonography is 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 the investigators define 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: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient of the Swiss IBD cohort study

• Diagnosis ulcerative colitis

• Past treatment with golimumab (at least one dose)

Exclusion Criteria:

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 (1)

Lead Sponsor	Collaborator
University of Zurich

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	12 months after first golimumab dose
Secondary	Remission at 12 months	Clinical remission at 12 months	12 months after first golimumab dose