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

• ClinicalTrials.gov Identifier: NCT03394586
• Recruitment Status: Unknown
• First Posted: January 9, 2018
• Last Update Posted: January 9, 2018
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

Study Description

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

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Study Chair: Gerhard Rogler, MD PhD; University of Zurich

More Information

Additional Information:

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

• 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:

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; Golimumab; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs