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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03394586
Date of registration:	28/12/2017
Prospective Registration:	Yes
Primary sponsor:	University of Zurich
Public title:	Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
Scientific title:	Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
Date of first enrolment:	January 1, 2018
Target sample size:	100
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT03394586
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Switzerland

Contacts

Name:	Benjamin Misselwitz, MD
Address:
Telephone:	0041 044 255 1111
Email:	benjamin.misselwitz@usz.ch
Affiliation:

Name:	Gerhard Rogler, MD PhD
Address:
Telephone:	++41 44 255 9519
Email:	gerhard.rogler@usz.ch
Affiliation:

Name:	Gerhard Rogler, MD PhD
Address:
Telephone:
Email:
Affiliation:	University of Zurich

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient of the Swiss IBD cohort study

- Diagnosis ulcerative colitis

- Past treatment with golimumab (at least one dose)

Exclusion Criteria:

- none

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Flare Up, Symptom

Intervention(s)

Drug: Exposure to golimumab

Primary Outcome(s)

Response at week 6-10 [Time Frame: 6-10 weeks after first golimumab dose]

Secondary Outcome(s)

Response at 6 months [Time Frame: 6 months after first golimumab dose]

Response at 12 months [Time Frame: 12 months after first golimumab dose]

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

Remission at 12 months [Time Frame: 12 months after first golimumab dose]

Remission at 6 months [Time Frame: 12 months after first golimumab dose]

Secondary ID(s)

Golimumab study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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