Ulcerative ColitisPhase 2GOLILORNCT03182166
Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
A Phase 2 study testing Golimumab (Optimization), Rectosigmoidoscopy and Blood samples in people with Ulcerative Colitis, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial summary
It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Golimumab (Optimization), Rectosigmoidoscopy and Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Nov 2017to 15 Dec 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affiliate or beneficiary of social security
- Age>18 years
- Pregnant women or man
- Presenting primary response under golimumab induction and in loss of response during maintenance therapy
- Patient with an ulcerative colitis
- Treated with golimumab
- Signature of consent
Who cannot join
- Trying to become pregnant
- Mental or emotional disorders
- Patients with crohn's disease or indeterminate colitis
- cancer(<5)
- Patients not in agreement with this study protocol
- Patients with crohn's disease or indeterminate colitis
- Patients non primary responder to golimumab
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Amiens-Picardie
Amiens
CHU Lyon Sud
Lyon
CHU Montpellier - St Eloi
Montpellier
CHU Nice
Nice
Chu Saint Etienne
Saint-Etienne, 42055
About this study
Official title: Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. All patients enrolled will give their written informed consent before being included. This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, in compliance with the approved protocol, good clinical practice and applicable regulatory requirements. Patients will visit the investigator from screening visit to visit 6 at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation, patients will record clinical parameters required to calculate the partial Mayo score reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8 (optional) and at the end of the follow-up to calculate total Mayo score.
- Conditions
- Ulcerative Colitis
- Being tested
- Golimumab (Optimization), Rectosigmoidoscopy, Blood samples
- Keywords
- golimumab, clinical response, mayo score, rectosigmoidoscopy, ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golimumab (Optimization)Drug
Increase dose of golimumab.
- For patients treated at 50 mg will be performed, dose will be intensified at 100 mg every four weeks.
- For patients treated at 100 mg will be performed, dose will be intensified at 100 mg every two weeks while four weeks.
RectosigmoidoscopyDiagnostic test
Rectosigmoidoscopy will be realized for calculated Mayo score
Blood samplesBiological
Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with golimumab | Experimental | The optimization procedure is:
* For patients treated at 50 mg of golimumab every 4 weeks (less than 80 kg) will have an increase dose of golimumab: 100 mg every 4 weeks for 8 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.
* For patients treated at 100 mg of golimumab every four weeks (more than 80 kg) will have an increase dose of golimumab: treated at 100 mg every 2 weeks for 4 weeks.
They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies. Receives: Drug: Golimumab (Optimization); Diagnostic Test: Rectosigmoidoscopy; Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between concentration of golimumab and clinical response according to treatment
Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA).
Clinical response is measured by the Mayo score.
Measured: From baseline to 8 weeks
Secondary outcomes (3)
Number of patient with antibodies to golimumab
Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay( ELISA)
Measured: day 1
correlation between concentration of antibodies to golimumab and clinical response according to treatment
Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA) Clinical response is measured by the Mayo score.
Measured: From baseline to 8 weeks
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start21 Nov 2017
- Primary completion25 Jun 2021
- Study completion15 Dec 2021
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 Centre Hospitalier Universitaire de Saint EtienneThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Xavier ROBLIN, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182166
- Sponsor's protocol ID
- 1608162
- Other IDs
- 2016-004245-85, 2016
- Acronym
- GOLILOR
- Status last verified
- Feb 2022
- First submitted
- 29 May 2017
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
- ClinicalTrials.gov ID
- NCT03182166
- Acronym / sponsor ID
- GOLILOR / 1608162
- Conditions
- Ulcerative Colitis
- Keywords
- golimumab, clinical response, mayo score, rectosigmoidoscopy, ulcerative colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 9 Jun 2017 (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.
It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. All patients enrolled will give their written informed consent before being included. This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, in compliance with the approved protocol, good clinical practice and applicable regulatory requirements. Patients will visit the investigator from screening visit to visit 6 at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation, patients will record clinical parameters required to calculate the partial Mayo score reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8 (optional) and at the end of the follow-up to calculate total Mayo score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with golimumab | Experimental | Drug: Golimumab (Optimization), Diagnostic Test: Rectosigmoidoscopy, Biological: Blood samplesThe optimization procedure is: * For patients treated at 50 mg of golimumab every 4 weeks (less than 80 kg) will have an increase dose of golimumab: 100 mg every 4 weeks for 8 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies. * For patients treated at 100 mg of golimumab every four weeks (more than 80 kg) will have an increase dose of golimumab: treated at 100 mg every 2 weeks for 4 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Affiliate or beneficiary of social security
- Age>18 years
- Pregnant women or man
- Presenting primary response under golimumab induction and in loss of response during maintenance therapy
- Patient with an ulcerative colitis
Key exclusion criteria (7 listed)
- Trying to become pregnant
- Mental or emotional disorders
- Patients with crohn's disease or indeterminate colitis
- cancer(<5)
- Patients not in agreement with this study protocol
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 |
|---|---|---|
| Golimumab (Optimization)Increase dose of golimumab. * For patients treated at 50 mg will be performed, dose will be intensified at 100 mg every four weeks. * For patients treated at 100 mg will be performed, dose will be intensified at 100 mg every two weeks while four weeks. | Drug | Patients treated with golimumab |
| RectosigmoidoscopyRectosigmoidoscopy will be realized for calculated Mayo score | Diagnostic test | Patients treated with golimumab |
| Blood samplesBlood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood | Biological | Patients treated with golimumab |
Primary outcome
correlation between concentration of golimumab and clinical response according to treatment
Time frame: From baseline to 8 weeks
Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA). Clinical response is measured by the Mayo score.
3 secondary outcomes
Number of patient with antibodies to golimumab
Time frame: day 1
correlation between concentration of antibodies to golimumab and clinical response according to treatment
Time frame: From baseline to 8 weeks
Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Xavier ROBLIN, MD PhD principal investigator
CHU de SAINT-ETIENNE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Golimumab (Optimization), Rectosigmoidoscopy and Blood samples in people with Ulcerative Colitis, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
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 7 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: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between concentration of golimumab and clinical response according to treatment (time frame: From baseline to 8 weeks). 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 14 Mar 2022.