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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
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date December 28, 2017
First Posted Date January 9, 2018
Last Update Posted Date January 9, 2018
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2018)
Response at week 6-10 [ Time Frame: 6-10 weeks after first golimumab dose ]
Clinical response at week 6-10
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 8, 2018)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
Official Title Real-world Data Regarding Treatment of Ulcerative Colitis Patients 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
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients from the Swiss IBD cohort study with ulcerative colitis treated with golimumab.
Condition
  • Ulcerative Colitis
  • Flare Up, Symptom
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.
Study Groups/Cohorts UC patients with golimumab
We will retrospectively analyze all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab.
Intervention: Drug: Exposure to golimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 8, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03394586
Other Study ID Numbers Golimumab study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators
Study Chair: Gerhard Rogler, MD PhD University of Zurich
PRS Account University of Zurich
Verification Date January 2018