Colitis, UlcerativePhase 4UC-GOLNCT02412085
Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission
A Phase 4 study testing Golimumab in people with Colitis, Ulcerative, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2015to Jan 2017
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18-65 years
- ability to understand the study procedures and sign the informed consent
- ulcerative colitis diagnosed at least 6 months before
- no previous exposure to anti-TNFs
- Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
- steroid-dependent disease
- women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation
Who cannot join
- Crohn's disease or undetermined colitis
- active infections or previous infections not completely resolved at baseline
- malignancies in the previous 5 years
- suspected latent tuberculosis infection
- every other potentially harmful clinical condition, in the opinion of the investigator
- patients with moderately to severe heart failure (NYHA class III/IV)
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- hepatic or renal failure
- pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion
- not permitted concomitant medications
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IBD Center
Rozzano, MI, 20089
Silvio Danese, MD, PhD, 0039028224 ext. 5555, sdanese@hotmail.com
About this study
Official title: Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis
This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.
At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.
Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.
- Conditions
- Colitis, Ulcerative
- Being tested
- Golimumab
- Keywords
- golimumab, ulcerative colitis, steroid-dependent
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabDrug
Also called Simponi
Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2)
Maintenance regimen:
- body weight < 80kg: 50 mg every 4 weeks
- body weight ≥ 80 kg: 100 mg every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Golimumab | Experimental | Subcutaneous golimumab Receives: Drug: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and endoscopic steroid-free remission
Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy.
Measured: week 16
Secondary outcomes (8)
clinical response
Decrease in total Mayo score of at least 2 point and 30 %
Measured: week 16
percentage of patients in clinical and endoscopic remission
Total Mayo score ≤2, with no sub-score >1
Measured: week 52
percentage of patients in clinical remission
partial Mayo score ≤2, with no sub-score >1
Measured: week 52
percentage of patients with mucosal healing
complete mucosal healing: endoscopic sub-score 0
Measured: week 16 and 52
percentage of patients with histological healing
histological healing: Geboes score <3 and no Mayo sub-score >1
Measured: week 16 and 52
quality of life
IBDQ questionnaire
Measured: week 16 and 52
percentage of infliximab responders
Measured: week 52
identification of patients that would benefit from golimumab therapy
evaluation of baseline characteristics of patients to identify potential response-predictive factors.
Measured: through week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvio Danese, MD, PhD, Study chair, IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412085
- Sponsor's protocol ID
- 1371
- Acronym
- UC-GOL
- Status last verified
- Apr 2015
- First submitted
- 26 Mar 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02412085
- Acronym / sponsor ID
- UC-GOL / 1371
- Conditions
- Colitis, Ulcerative
- Keywords
- golimumab, ulcerative colitis, steroid-dependent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- 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.
This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14.
At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52.
Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golimumab | Experimental | Drug: GolimumabSubcutaneous golimumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients aged 18-65 years
- ability to understand the study procedures and sign the informed consent
- ulcerative colitis diagnosed at least 6 months before
- no previous exposure to anti-TNFs
- Global Mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline
Key exclusion criteria (9 listed)
- Crohn's disease or undetermined colitis
- active infections or previous infections not completely resolved at baseline
- malignancies in the previous 5 years
- suspected latent tuberculosis infection
- every other potentially harmful clinical condition, in the opinion of the investigator
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 |
|---|---|---|
| GolimumabAlso: SimponiSubcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2) Maintenance regimen: * body weight < 80kg: 50 mg every 4 weeks * body weight ≥ 80 kg: 100 mg every 4 weeks | Drug | Golimumab |
Primary outcome
clinical and endoscopic steroid-free remission
Time frame: week 16
Total Mayo score ≤2, with no sub-score >1. No concomitant corticosteroid therapy.
8 secondary outcomes
clinical response
Time frame: week 16
percentage of patients in clinical and endoscopic remission
Time frame: week 52
percentage of patients in clinical remission
Time frame: week 52
percentage of patients with mucosal healing
Time frame: week 16 and 52
percentage of patients with histological healing
Time frame: week 16 and 52
quality of life
Time frame: week 16 and 52
percentage of infliximab responders
Time frame: week 52
identification of patients that would benefit from golimumab therapy
Time frame: through week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Silvio Danese, MD, PhD study chair
IBD Center, Humanitas Research Hospital, Rozzano (MI) ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Golimumab in people with Colitis, Ulcerative, run by Istituto Clinico Humanitas at 1 site in Italy.
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 7 inclusion and 9 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 8 Apr 2015. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Silvio Danese, MD, PhD (0039028224 ext. 5555, sdanese@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical and endoscopic steroid-free remission (time frame: week 16). 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 8 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.