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

NCT03394586 | Unknown

• 1 other identifier: Golimumab study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Ulcerative Colitis; Flare Up, Symptom

Keywords

Golimumab; TNF-inhibitors; Clinical Response; Clinical Remission; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Response at week 6-10

  Clinical response at week 6-10

  6-10 weeks after first golimumab dose

Secondary Outcomes (5)

• Response at 6 months

  6 months after first golimumab dose

• Response at 12 months

  12 months after first golimumab dose

• Remission at week 6-10

  6-10 weeks after first golimumab dose

• Remission at 6 months

  12 months after first golimumab dose

• Remission at 12 months

  12 months after first golimumab dose

Study Arms (1)

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

Interventions

Exposure to golimumab DRUG

retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.

UC patients with golimumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the Swiss IBD cohort study with ulcerative colitis treated with golimumab.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Division of Gastroenterology, University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Symptom Flare Up

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerhard Rogler, MD PhD

  University of Zurich

  STUDY CHAIR

Central Study Contacts

Benjamin Misselwitz, MD

CONTACT

0041 044 255 1111; benjamin.misselwitz@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 9, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

CH (1)