Clinical trial NCT03394586: Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
Official title: Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Flare Up, Symptom
Keywords: Golimumab
TNF-inhibitors
Clinical Response
Clinical Remission
Ulcerative Colitis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Swiss IBD cohort study with ulcerative colitis treated with golimumab.

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 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).

Detailed 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Response at week 6-10
timeFrame: 6-10 weeks after first golimumab dose
Secondary outcomes:
measure: Response at 6 months
timeFrame: 6 months after first golimumab dose
measure: Response at 12 months
timeFrame: 12 months after first golimumab dose
measure: Remission at week 6-10
timeFrame: 6-10 weeks after first golimumab dose
measure: Remission at 6 months
timeFrame: 12 months after first golimumab dose
measure: Remission at 12 months
timeFrame: 12 months after first golimumab dose
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Division of Gastroenterology, University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Gerhard Rogler, MD PhD
role: STUDY_CHAIR
References: