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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).


Condition or disease Intervention/treatment
Ulcerative Colitis Flare Up, Symptom Drug: Exposure to golimumab

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Response at week 6-10 [ Time Frame: 6-10 weeks after first golimumab dose ]
    Clinical response at week 6-10


Secondary Outcome Measures :
  1. Response at 6 months [ Time Frame: 6 months after first golimumab dose ]
    Clinical response at 6 months

  2. Response at 12 months [ Time Frame: 12 months after first golimumab dose ]
    Clinical response at 12 months

  3. Remission at week 6-10 [ Time Frame: 6-10 weeks after first golimumab dose ]
    Clinical remission at week 6-10

  4. Remission at 6 months [ Time Frame: 12 months after first golimumab dose ]
    Clinical remission at 6 months

  5. Remission at 12 months [ Time Frame: 12 months after first golimumab dose ]
    Clinical remission at 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from the Swiss IBD cohort study with ulcerative colitis treated with golimumab.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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


Contacts
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Contact: Benjamin Misselwitz, MD 0041 044 255 1111 benjamin.misselwitz@usz.ch

Locations
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Switzerland
Division of Gastroenterology, University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Gerhard Rogler, MD PhD    ++41 44 255 9519    gerhard.rogler@usz.ch   
Contact: Benjamin Misselwitz, MD    ++41 44 255 1111    benjamin.misselwitz@usz.ch   
Principal Investigator: Benjamin Misselwitz, MD         
Sponsors and Collaborators
University of Zurich
Investigators
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Study Chair: Gerhard Rogler, MD PhD University of Zurich
Additional Information:

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03394586    
Other Study ID Numbers: Golimumab study
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Golimumab
TNF-inhibitors
Clinical Response
Clinical Remission
Ulcerative Colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Symptom Flare Up
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Recurrence
Disease Attributes