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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03394586
Other study ID # Golimumab study
Secondary ID
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
Health authority
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:

Study Design


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
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