Ulcerative ColitisNCT03394586
Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
An observational study of Ulcerative Colitis and Flare Up, Symptom, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis, Flare Up, Symptom
- What is being tested?
- Exposure to golimumab
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 31 Dec 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the Swiss IBD cohort study with ulcerative colitis treated with golimumab.
Who may be able to join
- Patient of the Swiss IBD cohort study
- Diagnosis ulcerative colitis
- Past treatment with golimumab (at least one dose)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Division of Gastroenterology, University Hospital Zurich
Zurich, 8091
Gerhard Rogler, MD PhD, ++41 44 255 9519, gerhard.rogler@usz.ch
Benjamin Misselwitz, MD, ++41 44 255 1111, benjamin.misselwitz@usz.ch
About this study
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).
Read the 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
- Conditions
- Ulcerative Colitis, Flare Up, Symptom
- Being tested
- Exposure to golimumab
- Keywords
- Golimumab, TNF-inhibitors, Clinical Response, Clinical Remission, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative, Symptom Flare Up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to golimumabDrug
retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.
| Study group | Role | What they receive |
|---|---|---|
| UC patients with golimumab | We will retrospectively analyze all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab. Receives: Drug: Exposure to golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response at week 6-10
Clinical response at week 6-10
Measured: 6-10 weeks after first golimumab dose
Secondary outcomes (5)
Response at 6 months
Clinical response at 6 months
Measured: 6 months after first golimumab dose
Response at 12 months
Clinical response at 12 months
Measured: 12 months after first golimumab dose
Remission at week 6-10
Clinical remission at week 6-10
Measured: 6-10 weeks after first golimumab dose
Remission at 6 months
Clinical remission at 6 months
Measured: 12 months after first golimumab dose
Remission at 12 months
Clinical remission at 12 months
Measured: 12 months after first golimumab dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Rogler, MD PhD, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394586
- Sponsor's protocol ID
- Golimumab study
- Status last verified
- Jan 2018
- First submitted
- 28 Dec 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
- ClinicalTrials.gov ID
- NCT03394586
- Acronym / sponsor ID
- Golimumab study
- Conditions
- Ulcerative Colitis, Flare Up, Symptom
- Keywords
- Golimumab, TNF-inhibitors, Clinical Response, Clinical Remission, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC patients with golimumab | – | Drug: Exposure to golimumabWe will retrospectively analyze all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the Swiss IBD cohort study with ulcerative colitis treated with golimumab.
Key inclusion criteria (3 listed)
- Patient of the Swiss IBD cohort study
- Diagnosis ulcerative colitis
- Past treatment with golimumab (at least one dose)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to golimumabretrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months. | Drug | UC patients with golimumab |
Primary outcome
Response at week 6-10
Time frame: 6-10 weeks after first golimumab dose
Clinical response at week 6-10
5 secondary outcomes
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 6 months
Time frame: 12 months after first golimumab dose
Remission at 12 months
Time frame: 12 months after first golimumab dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Rogler, MD PhD study chair
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Flare Up, Symptom, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Misselwitz, MD (0041 044 255 1111, benjamin.misselwitz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response at week 6-10 (time frame: 6-10 weeks after first golimumab dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.