UveitisPhase 2NCT04588818
Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis
A Phase 2 study testing Adalimumab plus Methotrexate in people with Uveitis, run by Sun Yat-sen University at 1 site in China.
Trial summary
The aim of this study is to determine the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Adalimumab plus Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 31 Dec 2023
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of non-infectious panuveitis
- Age from 2 to 16 years old
- Vision threatening non-infectious uveitis hadn't received standardized systematic treatment before
Who cannot join
- Patients who had active infection (including hepatitis B or C infection, tuberculosis), malignancy diseases, or bilateral irreversible blindness and any other contraindications of ADA
- previous exposure to another biologic agent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Dan Liang, MD, 0086-20-87330402, liangd2@mail.sysu.edu.cn
Dan Liang, MD
About this study
Official title: Adalimumab in Combination With Methotrexate for the Treatment of Non-infectious Panuveitis in Chinese Children
The aim of this study is to determine the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis.
Read the detailed description
Although non-infectious uveitis is rare in pediatric population, the irreversible visual impairment due to ocular complications, severe drug adverse effects are disturbing. There is a high rate of chronic disorder of ocular inflammation and unresponsiveness of therapy drugs in pediatric uveitis, which result in structure destruction and functional impairment including band keratopathy, posterior synechiae, cataract, and so on. The systemic and topical glucocorticoid are advocated to control inflammation but carry a high risk of lots of advert events.
Methotrexate is now highly recommended to control uveitis and most commonly prescribed in pediatric uveitis. it was benefit to prolong remission and reduce recurrence. However, despite early intervention 27-48% children do not achieve control of inflammation and 20% experience adverse events. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of many rheumatic diseases. ADA as the initial treatment in adult patients of uveitis lead to a more optimistic prognosis, a better visual acuity and a lower dose of dosage of daily glucocorticoid.
The investigators propose to test the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis who were followed up for 1 year.
- Conditions
- Uveitis
- Being tested
- Adalimumab plus Methotrexate
- Keywords
- Pediatric Panuveitis, Methotrexate, Adalimumab
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab plus MethotrexateDrug
Adalimumab 40 mg (≥30kg weight) or 20mg (<30kg weight) subcutaneously every other week without loading dose.
Methotrexate(10 to 20 mg per square meter of body-surface area; maximum dose, 20 mg) .
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab plus Methotrexate | Experimental | Not described Receives: Drug: Adalimumab plus Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to reach the remission
Measured: 12 months
Secondary outcomes (4)
the time of a first relapse once remission
Measured: 12 months
macular structure
decrease of central foveal thickness
Measured: 12 months
the total dosage of corticosteriod or the time to steroid discontinuation
Measured: 12 months
Best corrected visual Acuityand
increase of BCVA
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 posted19 Oct 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Liang, Sun Yat-sen University
- Investigators
- Dan Liang, MD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588818
- Sponsor's protocol ID
- 2020-ADA-Uveitis
- Status last verified
- Dec 2021
- First submitted
- 9 Oct 2020
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Teabagy S, Wood E, Bilsbury E, Doherty S, Janardhana P, Lee DJ. Ocular immunosuppressive microenvironment and novel drug delivery for control of uveitis. Adv Drug Deliv Rev. 2023 Jul;198:114869. doi: 10.1016/j.addr.2023.114869. Epub 2023 May 10.
PubMed 37172782
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab in Combination With Methotrexate for the Treatment of Non-infectious Panuveitis in Chinese Children
- ClinicalTrials.gov ID
- NCT04588818
- Acronym / sponsor ID
- 2020-ADA-Uveitis
- Conditions
- Uveitis
- Keywords
- Pediatric Panuveitis, Methotrexate, Adalimumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Oct 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 study is to determine the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis.
Detailed description
Although non-infectious uveitis is rare in pediatric population, the irreversible visual impairment due to ocular complications, severe drug adverse effects are disturbing. There is a high rate of chronic disorder of ocular inflammation and unresponsiveness of therapy drugs in pediatric uveitis, which result in structure destruction and functional impairment including band keratopathy, posterior synechiae, cataract, and so on. The systemic and topical glucocorticoid are advocated to control inflammation but carry a high risk of lots of advert events.
Methotrexate is now highly recommended to control uveitis and most commonly prescribed in pediatric uveitis. it was benefit to prolong remission and reduce recurrence. However, despite early intervention 27-48% children do not achieve control of inflammation and 20% experience adverse events. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of many rheumatic diseases. ADA as the initial treatment in adult patients of uveitis lead to a more optimistic prognosis, a better visual acuity and a lower dose of dosage of daily glucocorticoid.
The investigators propose to test the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis who were followed up for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab plus Methotrexate | Experimental | Drug: Adalimumab plus Methotrexate |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of non-infectious panuveitis
- Age from 2 to 16 years old
- Vision threatening non-infectious uveitis hadn't received standardized systematic treatment before
Key exclusion criteria (2 listed)
- Patients who had active infection (including hepatitis B or C infection, tuberculosis), malignancy diseases, or bilateral irreversible blindness and any other contraindications of ADA
- previous exposure to another biologic agent
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 |
|---|---|---|
| Adalimumab plus MethotrexateAdalimumab 40 mg (≥30kg weight) or 20mg (<30kg weight) subcutaneously every other week without loading dose. Methotrexate(10 to 20 mg per square meter of body-surface area; maximum dose, 20 mg) . | Drug | Adalimumab plus Methotrexate |
Primary outcome
the time to reach the remission
Time frame: 12 months
4 secondary outcomes
the time of a first relapse once remission
Time frame: 12 months
macular structure
Time frame: 12 months
the total dosage of corticosteriod or the time to steroid discontinuation
Time frame: 12 months
Best corrected visual Acuityand
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 28 Dec 2021.
- Derived from this study: PubMed 37172782Teabagy S, Wood E, Bilsbury E, Doherty S, Janardhana P, Lee DJ. Ocular immunosuppressive microenvironment and novel drug delivery for control of uveitis. Adv Drug Deliv Rev. 2023 Jul;198:114869. doi: 10.1016/j.addr.2023.114869. Epub 2023 May 10.
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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.
Dan Liang, MD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 Adalimumab plus Methotrexate in people with Uveitis, run by Sun Yat-sen 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 3 inclusion and 2 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 28 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Liang, MD (0086-20-87330402, liangd2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to reach the remission (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588818, which also lists 1 linked publication.
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 28 Dec 2021.