Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
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|ClinicalTrials.gov Identifier: NCT03394586|
Recruitment Status : Unknown
Verified January 2018 by University of Zurich.
Recruitment status was: Recruiting
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
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).
|Condition or disease||Intervention/treatment|
|Ulcerative Colitis Flare Up, Symptom||Drug: Exposure to golimumab|
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
- Calprotectin (cut off 100microg/g)
- 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
- calprotectin (cut off 100microg/g)
- CRP and anemia
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
UC patients with golimumab
We will retrospectively analyze all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab.
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.
- Response at week 6-10 [ Time Frame: 6-10 weeks after first golimumab dose ]Clinical response at week 6-10
- Response at 6 months [ Time Frame: 6 months after first golimumab dose ]Clinical response at 6 months
- Response at 12 months [ Time Frame: 12 months after first golimumab dose ]Clinical response at 12 months
- Remission at week 6-10 [ Time Frame: 6-10 weeks after first golimumab dose ]Clinical remission at week 6-10
- Remission at 6 months [ Time Frame: 12 months after first golimumab dose ]Clinical remission at 6 months
- Remission at 12 months [ Time Frame: 12 months after first golimumab dose ]Clinical remission at 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394586
|Contact: Benjamin Misselwitz, MD||0041 044 255 firstname.lastname@example.org|
|Division of Gastroenterology, University Hospital Zurich||Recruiting|
|Zurich, Switzerland, 8091|
|Contact: Gerhard Rogler, MD PhD ++41 44 255 9519 email@example.com|
|Contact: Benjamin Misselwitz, MD ++41 44 255 1111 firstname.lastname@example.org|
|Principal Investigator: Benjamin Misselwitz, MD|
|Study Chair:||Gerhard Rogler, MD PhD||University of Zurich|