Behcet SyndromePhase 2NCT04218565
Golimumab for the Treatment of Refractory Behcet's Uveitis
A Phase 2 study testing Golimumab (GOL) in people with Behcet Syndrome and Uveitis, run by Wenjie Zheng at 1 site in China.
Trial summary
The aim of this single-center prospective study is to evaluate the efficacy and safety of Golimumab （GOL）, fully humanized anti-tumor necrosis factor (TNF)-α monoclonal antibody, in the treatment of refractory Uveitis of Behçet's disease (BDU), to verify its effects on decreasing the dose of cortical steroids, and to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Behcet Syndrome, Uveitis
- What is being tested?
- Golimumab (GOL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2020to 15 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants fulfill the proposed International Criteria for BD, either ISG (International Study Group) criteria(1990) or ICBD(International Conference on Behcet's Disease) criteria(2013).
- All participants present with refractory BDU, acute onset uveitis, either posterior segment involvement or panuveitis, with difficulty tapering corticosteroids while being treated with at least one of the commonly used immunosuppressants, without severe extraocular manifestations.
Who cannot join
- Patients with impaired hepatic and renal function, other severe ocular diseases, active tuberculosis, viral hepatitis, malignancy, pregnancy, congestive heart failure, or had biologics treatment within three months will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Efficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease
The aim of this single-center prospective study is to evaluate the efficacy and safety of Golimumab （GOL）, fully humanized anti-tumor necrosis factor (TNF)-α monoclonal antibody, in the treatment of refractory Uveitis of Behçet's disease (BDU), to verify its effects on decreasing the dose of cortical steroids, and to determine whether it can reduce BDU recurrence.
Read the detailed description
Uveitis of Behçet's disease (BDU) is the most common form of ocular manifestations, which is also the leading cause of irreversible visual impairment. The aim of the study is to improve the treatment strategy of the disease as well as to reduce blindness.
Monoclonal anti-TNF antibodies were recommended in 2018 recommendations for treating eye involvement affecting the posterior segment (level of evidence: IIA; strength of recommendation: B), Infliximab was mentioned for the treatment of initial or recurrent episode of acute sight-threatening uveitis.
Golimumab （GOL）is a fully-humanized anti-TNF-α monoclonal antibody, retrospective study on non-infectious uveitis and BDU has obtained promising results.
This single-center prospective study is to evaluate the efficacy and safety of GOL in the treatment of refractory BDU, to verify its effects on tapering the dose of corticosteroids, and to determine whether it can reduce BDU recurrence. We aim to enroll nine refractory BDU patients with acute onset posterior uveitis, with difficulty tapering corticosteroids while being treated with at least one of the commonly used immunosuppressants.
All participants will receive GOL monthly for six months, oral immunosuppressants will remain unchanged. During follow-up, intraocular inflammation status, BCVA, as well as extraocular manifestations, will be recorded. The primary endpoints are the efficacy of the first dose of GOL, and the recurrence of uveitis after 12 months of treatment. Secondary endpoints other than intraocular inflammation will be achieved on each follow-up visit, as the quality of life improvements, side effects, recurrence of uveitis, and corticosteroids-tapering effects.
On statistical analysis, the self-control treatment efficiency and recurrence rate difference will be determined using T-test of paired samples at a significance level of 0.05(2-sided).
To ensure the interest of the participants, our study has been reviewed by the ethics committee, and drug clinical research liability insurance was prepared.
- Conditions
- Behcet Syndrome, Uveitis
- Being tested
- Golimumab (GOL)
- Medical subject headings
- Behcet Syndrome, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golimumab (GOL)Biological
Patients with refractory BD associated uveitis will receive Golimumab therapy, the efficacy and corticosteroids-sparing effects will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Golimumab for refractory BDU | Experimental | This study is a self-control study and all the participants will be enrolled in the interventional arm. Receives: Biological: Golimumab (GOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Golimumab on BD Uveitis
Efficacy of Golimumab based on Behçet's disease ocular attack score 24 （BOS24）
Measured: four weeks
Efficacy of Golimumab on BD Uveitis
Efficacy of Golimumab based on Best corrected visual acuity(BCVA)
Measured: four weeks
Efficacy of Golimumab on BD Uveitis
Efficacy of Golimumab based on Optical Coherence tomography(OCT)).
Measured: four weeks
Difference of recurrence rate before and after intervention
Difference of recurrence rate of uveitis before and after 12 months of GOL treatment
Measured: 12 months
Secondary outcomes (9)
Intraocular inflammation evaluation BOS24 index
Visual acuity, anterior chamber cells, vitreous opacities, retinal inflammation, macular thickness, etc.
Measured: each follow-up visit / every four weeks, up to six months
Corticosteroid-tapering effects
Corticosteroid will be tapered to minimum dose(Prednisone 5-10mg/d) within four months during the course of GOL treatment.
Measured: six months
Changes of uveitis recurrence
Changes of recurrence rate before and after six months of GOL treatment.
Measured: six months
Severity of uveitis on recurrence
Differences of severity of recurrence before and after treatment, measured by BOS24.
Measured: six months
Severity of uveitis on recurrence
Differences of severity of recurrence before and after treatment, measured by , BCVA.
Measured: six months
Severity of uveitis on recurrence
Differences of severity of recurrence before and after treatment, measured by OCT.
Measured: six months
Impact on quality of life
Record quality of life on questionnaire, BehÇet's disease current activity form 2006（BDCAF2006）.
Measured: each follow-up visit / every four weeks, up to six months
Impact on quality of life
Record quality of life on questionnaire, short from Health Survey(SF-36).
Measured: each follow-up visit / every four weeks, up to six months
Side effects of treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start15 Feb 2020
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Why it stopped: only one patient enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet SyndromeStudies of the same condition, open and under way.
- 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
- Model description
- Golimumab is approved for the treatment of several inflammatory diseases, the self-control study aims to evaluate the response to GOL in refractory BDU.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenjie Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenjie Zheng, Peking Union Medical College Hospital
- Investigators
- Wenjie Zheng, M.D., Principal investigator, Department of Rheumatology, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218565
- Sponsor's protocol ID
- GOL-BDU-PUMCH
- Status last verified
- Apr 2023
- First submitted
- 8 Dec 2019
- Last updated
- 7 Apr 2023
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Golimumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease
- ClinicalTrials.gov ID
- NCT04218565
- Acronym / sponsor ID
- GOL-BDU-PUMCH
- Conditions
- Behcet Syndrome, Uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: only one patient enrolled
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wenjie ZhengUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 6 Jan 2020 (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.
The aim of this single-center prospective study is to evaluate the efficacy and safety of Golimumab （GOL）, fully humanized anti-tumor necrosis factor (TNF)-α monoclonal antibody, in the treatment of refractory Uveitis of Behçet's disease (BDU), to verify its effects on decreasing the dose of cortical steroids, and to determine whether it can reduce BDU recurrence.
Detailed description
Uveitis of Behçet's disease (BDU) is the most common form of ocular manifestations, which is also the leading cause of irreversible visual impairment. The aim of the study is to improve the treatment strategy of the disease as well as to reduce blindness.
Monoclonal anti-TNF antibodies were recommended in 2018 recommendations for treating eye involvement affecting the posterior segment (level of evidence: IIA; strength of recommendation: B), Infliximab was mentioned for the treatment of initial or recurrent episode of acute sight-threatening uveitis.
Golimumab （GOL）is a fully-humanized anti-TNF-α monoclonal antibody, retrospective study on non-infectious uveitis and BDU has obtained promising results.
This single-center prospective study is to evaluate the efficacy and safety of GOL in the treatment of refractory BDU, to verify its effects on tapering the dose of corticosteroids, and to determine whether it can reduce BDU recurrence. We aim to enroll nine refractory BDU patients with acute onset posterior uveitis, with difficulty tapering corticosteroids while being treated with at least one of the commonly used immunosuppressants.
All participants will receive GOL monthly for six months, oral immunosuppressants will remain unchanged. During follow-up, intraocular inflammation status, BCVA, as well as extraocular manifestations, will be recorded. The primary endpoints are the efficacy of the first dose of GOL, and the recurrence of uveitis after 12 months of treatment. Secondary endpoints other than intraocular inflammation will be achieved on each follow-up visit, as the quality of life improvements, side effects, recurrence of uveitis, and corticosteroids-tapering effects.
On statistical analysis, the self-control treatment efficiency and recurrence rate difference will be determined using T-test of paired samples at a significance level of 0.05(2-sided).
To ensure the interest of the participants, our study has been reviewed by the ethics committee, and drug clinical research liability insurance was prepared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Golimumab is approved for the treatment of several inflammatory diseases, the self-control study aims to evaluate the response to GOL in refractory BDU.
| Arm | Type | Receives |
|---|---|---|
| Golimumab for refractory BDU | Experimental | Biological: Golimumab (GOL)This study is a self-control study and all the participants will be enrolled in the interventional arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All participants fulfill the proposed International Criteria for BD, either ISG (International Study Group) criteria(1990) or ICBD(International Conference on Behcet's Disease) criteria(2013).
- All participants present with refractory BDU, acute onset uveitis, either posterior segment involvement or panuveitis, with difficulty tapering corticosteroids while being treated with at least one of the commonly used immunosuppressants, without severe extraocular manifestations.
Key exclusion criteria (1 listed)
- Patients with impaired hepatic and renal function, other severe ocular diseases, active tuberculosis, viral hepatitis, malignancy, pregnancy, congestive heart failure, or had biologics treatment within three months will be excluded.
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 (GOL)Patients with refractory BD associated uveitis will receive Golimumab therapy, the efficacy and corticosteroids-sparing effects will be evaluated. | Biological | Golimumab for refractory BDU |
Primary outcome
Efficacy of Golimumab on BD Uveitis
Time frame: four weeks
Efficacy of Golimumab based on Behçet's disease ocular attack score 24 （BOS24）
Efficacy of Golimumab on BD Uveitis
Time frame: four weeks
Efficacy of Golimumab based on Best corrected visual acuity(BCVA)
Efficacy of Golimumab on BD Uveitis
Time frame: four weeks
Efficacy of Golimumab based on Optical Coherence tomography(OCT)).
Difference of recurrence rate before and after intervention
Time frame: 12 months
Difference of recurrence rate of uveitis before and after 12 months of GOL treatment
9 secondary outcomes
Intraocular inflammation evaluation BOS24 index
Time frame: each follow-up visit / every four weeks, up to six months
Corticosteroid-tapering effects
Time frame: six months
Changes of uveitis recurrence
Time frame: six months
Severity of uveitis on recurrence
Time frame: six months
Severity of uveitis on recurrence
Time frame: six months
Severity of uveitis on recurrence
Time frame: six months
Impact on quality of life
Time frame: each follow-up visit / every four weeks, up to six months
Impact on quality of life
Time frame: each follow-up visit / every four weeks, up to six months
Side effects of treatment
Time frame: six months
Results and safety
The study was stopped early (reason given: only one patient enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- 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.
Wenjie Zheng, M.D. principal investigator
Department of Rheumatology, Peking Union Medical College Hospital
1 site 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 (GOL) in people with Behcet Syndrome and Uveitis, run by Wenjie Zheng at 1 site in China.
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 2 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: stopped early, as of the sponsor's last update on 7 Apr 2023. 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 China. 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 was stopped early (reason given: only one patient enrolled). Results are not available in the source record.
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?
Efficacy of Golimumab on BD Uveitis (time frame: four weeks). The study lists 4 primary outcomes in all. 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 7 Apr 2023.