UveitisPhase 2NCT05155592
Reduction or Discontinuation of TNF-α Inhibitor in Non-infectious Uveitis Patients
A Phase 2 study testing reduction or discontinuation of Adalimumab in people with Uveitis and Adalimumab, run by Dan Liang at 1 site in China.
Trial summary
TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to… Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Uveitis, Adalimumab
- What is being tested?
- reduction or discontinuation of Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Apr 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of non-infectious uveitis
- nflammation was controlled for 6 months after drug remission was achieved using Adalimumab in combination with immunosuppressant therapy
- Family members and patients who are willing to stop should agree and accept relevant examinations
- The informed consent is read and signed by the patient or a legally authorized represent
Who cannot join
- Unwilling to sign informed consent
- There is systemic autoimmune disease uncontrolled situation
- Patients who may require surgery in the near future
- Vision meets the standards of low vision and blindness
- Silicone oil or gas filling after vitreous surgery
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, PhD, 0086-20-87330402, liangd2@mail.sysu.edu.cn
About this study
Official title: Study of TNF-α Inhibitor Reduction or Discontinuation in Patients With Non-infectious Uveitis
TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.
Read the detailed description
TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. Previous studies have reported that tapering or discontinuation of Adalimumab may be considered in patients with stable disease. In clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.
- Conditions
- Uveitis, Adalimumab
- Being tested
- reduction or discontinuation of Adalimumab
- Keywords
- Uveitis, Adalimumab, TNF-α inhibitor
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduction or discontinuation of AdalimumabBiological
For patients with non-infectious uveitis whose inflammation stabilizes after treated with Adalimumab, extended dosing intervals to once a month, during which inflammatory status is monitored. If there was no recurrence within 6 months, Adalimumab was discontinued, and whether inflammation recurred after withdrawal was observed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with inactive uveitis | Experimental | Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab Receives: Biological: reduction or discontinuation of Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate of inflammation
The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation
Measured: 24 months
Secondary outcomes (2)
Best corrected visual Acuity
increase of BCVA
Measured: 24 months
macular structure
Macular thickness (MT). increase of central foveal thickness
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies 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
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dan Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Liang, Sun Yat-sen University
- Investigators
- Dan Liang, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155592
- Sponsor's protocol ID
- 2021-ADA-Stop
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan PD, Hu YW, Chen XQ, Chen GY, Pan Y, Lao HY, Liang D. Adalimumab Dose Reduction and Withdrawal in Stable Non-Infectious Pediatric Uveitis: An Open-Label, Prospective, Pilot Study. Ocul Immunol Inflamm. 2025 Apr;33(3):332-339. doi: 10.1080/09273948.2024.2343084. Epub 2024 Apr 23.
PubMed 38652891Teabagy 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 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of TNF-α Inhibitor Reduction or Discontinuation in Patients With Non-infectious Uveitis
- ClinicalTrials.gov ID
- NCT05155592
- Acronym / sponsor ID
- 2021-ADA-Stop
- Conditions
- Uveitis, Adalimumab
- Keywords
- Uveitis, Adalimumab, TNF-α inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Dan LiangUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 13 Dec 2021 (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.
TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.
Detailed description
TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. Previous studies have reported that tapering or discontinuation of Adalimumab may be considered in patients with stable disease. In clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with inactive uveitis | Experimental | Biological: reduction or discontinuation of AdalimumabPatients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of non-infectious uveitis
- nflammation was controlled for 6 months after drug remission was achieved using Adalimumab in combination with immunosuppressant therapy
- Family members and patients who are willing to stop should agree and accept relevant examinations
- The informed consent is read and signed by the patient or a legally authorized represent
Key exclusion criteria (5 listed)
- Unwilling to sign informed consent
- There is systemic autoimmune disease uncontrolled situation
- Patients who may require surgery in the near future
- Vision meets the standards of low vision and blindness
- Silicone oil or gas filling after vitreous surgery
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 |
|---|---|---|
| reduction or discontinuation of AdalimumabFor patients with non-infectious uveitis whose inflammation stabilizes after treated with Adalimumab, extended dosing intervals to once a month, during which inflammatory status is monitored. If there was no recurrence within 6 months, Adalimumab was discontinued, and whether inflammation recurred after withdrawal was observed. | Biological | Patients with inactive uveitis |
Primary outcome
relapse rate of inflammation
Time frame: 24 months
The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation
2 secondary outcomes
Best corrected visual Acuity
Time frame: 24 months
macular structure
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Derived from this study: PubMed 38652891Yuan PD, Hu YW, Chen XQ, Chen GY, Pan Y, Lao HY, Liang D. Adalimumab Dose Reduction and Withdrawal in Stable Non-Infectious Pediatric Uveitis: An Open-Label, Prospective, Pilot Study. Ocul Immunol Inflamm. 2025 Apr;33(3):332-339. doi: 10.1080/09273948.2024.2343084. Epub 2024 Apr 23.
- 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.
- 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.
Dan Liang, PhD 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 reduction or discontinuation of Adalimumab in people with Uveitis and Adalimumab, run by Dan Liang 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 4 inclusion and 5 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 13 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, PhD (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?
relapse rate of inflammation (time frame: 24 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 NCT05155592, which also lists 2 linked publications.
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 13 Dec 2021.