Vogt-Koyanagi-Harada DiseaseNCT05590416
A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
An observational study of Vogt-Koyanagi-Harada Disease and Adalimumab, run by Tianjin Medical University at 1 site in China.
Trial summary
This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vogt-Koyanagi-Harada Disease, Adalimumab
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Dec 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital
Who may be able to join
- Subject is 18 to 70 years of age.
- Subjects who do not have previous, active or latent tuberculosis (TB).
- Subject must have Vogt-Koyanagi-Harada disease less than one month.
- Subject who were previously treated with systemic glucocorticoid less than one week.
- Subject meets at least 1 of the following criteria:
- 1)patients who reject using systemic glucocorticoid because of the long-term side effects. 2)patients with other high-risk or systemic disease were limited by the use of glucocorticoid. 3)patients with a little reparation of retinal detachments after a week treatment with powerful systemic glucocorticoid(≥1mg/kg/day).
Who cannot join
- Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
- Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
- Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
- Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
- Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
- Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300000
xiaomin Zhang, +8613920023990, xiaomzh@126.com
About this study
Official title: An Observational Study of Adalimumab in the Treatment of Acute Vogt-Koyanagi-Harada Disease
This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease
Read the detailed description
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of adalimumab, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with acute VKH divided into two groups: adalimumab therapy group and traditional therapy group.
For adalimumab therapy group, an initial dose of 80 mg adalimumab was administered subcutaneously followed by a maintenance dose of 40 mg every two weeks, and data will be collected prospectively with regard to ophthalmologic outcomes. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants. Study participants will be followed for up to one year to determine efficacy and side effects.
According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and immunosuppressive effects of adalimumab in treatment of acute VKH.
- Conditions
- Vogt-Koyanagi-Harada Disease, Adalimumab
- Being tested
- Adalimumab
- Medical subject headings
- Uveomeningoencephalitic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart.
| Study group | Role | What they receive |
|---|---|---|
| adalimumab group | The initial dose of glucocorticoid is 1 mg/kg/day, and gradually stops within 90-180 days. Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart. Receives: Drug: Adalimumab | |
| traditional therapy group | Acute VKH patients treatment with only glucocorticosteroid or glucocorticosteroid combined with immunosuppressive agents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
The participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
Measured: 24 weeks
Recurrence rate
The recurrence rates in adalimumab treatment group and control group
Measured: 24 weeks
Secondary outcomes (2)
Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit
Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:
Grade 0 = < 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = > 50 cells.
Measured: 24 weeks
Prednisone exposure
Cumulative prednisone dose and/or mean prednisone dose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Jun 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vogt-Koyanagi-Harada DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomin Zhang, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590416
- Sponsor's protocol ID
- 2022KY-16
- Status last verified
- Jul 2024
- First submitted
- 19 Oct 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Adalimumab in the Treatment of Acute Vogt-Koyanagi-Harada Disease
- ClinicalTrials.gov ID
- NCT05590416
- Acronym / sponsor ID
- 2022KY-16
- Conditions
- Vogt-Koyanagi-Harada Disease, Adalimumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Oct 2022 (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.
This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease
Detailed description
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of adalimumab, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with acute VKH divided into two groups: adalimumab therapy group and traditional therapy group.
For adalimumab therapy group, an initial dose of 80 mg adalimumab was administered subcutaneously followed by a maintenance dose of 40 mg every two weeks, and data will be collected prospectively with regard to ophthalmologic outcomes. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants. Study participants will be followed for up to one year to determine efficacy and side effects.
According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and immunosuppressive effects of adalimumab in treatment of acute VKH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adalimumab group | – | Drug: AdalimumabThe initial dose of glucocorticoid is 1 mg/kg/day, and gradually stops within 90-180 days. Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart. |
| traditional therapy group | – | –Acute VKH patients treatment with only glucocorticosteroid or glucocorticosteroid combined with immunosuppressive agents. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- VKH patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital
Key inclusion criteria (6 listed)
- Subject is 18 to 70 years of age.
- Subjects who do not have previous, active or latent tuberculosis (TB).
- Subject must have Vogt-Koyanagi-Harada disease less than one month.
- Subject who were previously treated with systemic glucocorticoid less than one week.
- Subject meets at least 1 of the following criteria:
Key exclusion criteria (6 listed)
- Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
- Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
- Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
- Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
- Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
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 |
|---|---|---|
| AdalimumabAdalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart. | Drug | adalimumab group |
Primary outcome
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
Time frame: 24 weeks
The participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
Recurrence rate
Time frame: 24 weeks
The recurrence rates in adalimumab treatment group and control group
2 secondary outcomes
Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit
Time frame: 24 weeks
Prednisone exposure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Related trials for Vogt-Koyanagi-Harada Disease
Recruiting
Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
Vogt Koyanagi Harada Disease
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.
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 Vogt-Koyanagi-Harada Disease and Adalimumab, run by Tianjin Medical University 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 6 inclusion and 6 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 3 Jul 2024. 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.
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 xiaomin zhang, M.D (+86-13920023990, xiaomzh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit. (time frame: 24 weeks). The study lists 2 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 3 Jul 2024.