Non-infectious Anterior UveitisPANDA-UNCT07913750
Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
A study testing Adalimumab PFS and Pen in people with Non-infectious Anterior Uveitis and Non-infectious Intermediate Uveitis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to evaluate the clinical efficacy and safety of adalimumab in pediatric non-infectious uveitis and to generate domestic real-world evidence (RWE), thereby establishing a clinical foundation for label expansion and reimbursement coverage. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis
- What is being tested?
- Adalimumab PFS and Pen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For the Prospective New-User Cohort, verification of Inclusion Criteria 1 through 6 is required.
- For the Retrospective (Switch) Cohort, verification of Inclusion Criteria 1 through 7 is required.
- Pediatric patients aged 2 years and < 18 years.
- Diagnosed with non-infectious anterior uveitis, intermediate uveitis, posterior uveitis, or panuveitis.
- Active intraocular inflammation demonstrated by anterior chamber (AC) cell grade ≥ 1+ (defined as 6 cells per 1 mm\times 1 mm field) according to the SUN (Standardization of Uveitis Nomenclature) criteria, or active posterior segment lesions persistently observed on at least two consecutive assessments despite 12 weeks of treatment with methotrexate and corticosteroids (systemic or topical) prior to screening (SUN grade maintained on 2 occasions, adapted from the SYCAMORE trial definition of active disease).
- Inadequate response to corticosteroid therapy or other immunosuppressive agents (e.g., methotrexate [MTX]), or inability to continue treatment due to unacceptable toxicity/intolerance.
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- Written informed consent obtained from the subject's legal representative (parent or legal guardian) and written pediatric assent obtained according to applicable age-specific regulatory and institutional guidelines.
- [Prospective De Novo Cohort]
- Patients initiating adalimumab for the first time (adalimumab-naïve).
- [Retrospective / Prospective Cohort] 6. Patients currently on maintenance therapy with adalimumab (including extended dosing intervals, such as every other week [Q2W] or every 3-4 weeks) who require at least 1 additional year of treatment.
- 7. Patients who agree to switch to the investigational product and adhere to a standard every-other-week (Q2W / once every 2 weeks) administration schedule at the time of study enrollment.
Who cannot join
- For the Prospective New-User Cohort, verification of Exclusion Criteria 1 through 22 is required.
- For the Retrospective (Switch) Cohort, verification of Exclusion Criteria 1 through 24 is required.
- Patients with uveitis associated with juvenile idiopathic arthritis (JIA) or pediatric Crohn's disease indicated for adalimumab
- Individuals with infectious uveitis or non-immunological intraocular inflammation resulting from trauma, surgery, etc., within 30 days prior to screening
- Individuals with active tuberculosis, untreated latent tuberculosis, sepsis, opportunistic infections, or other severe active infections, or those at high risk for such infections
- Individuals with a history of hypersensitivity to adalimumab or any of its excipients
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- Individuals instilling topical glucocorticoids more than 6 times per eye per day, or currently receiving oral prednisone (or its equivalent) at a dose exceeding 0.2 mg/kg/day (adapted from the SYCAMORE criteria)
- Individuals with active malignancy, lymphoproliferative disorders, demyelinating disease (e.g., multiple sclerosis, Guillain-Barré syndrome), or a history of other progressive or degenerative neurological disorders
- Patients who have received TNF inhibitors other than the investigational product
- Patients with New York Heart Association (NYHA) Class III/IV cardiac disease
- Individuals with uncontrolled viral infections, including active hepatitis B or hepatitis C
- Individuals who have received a live vaccine (including live-attenuated vaccines) within 30 days prior to screening, or who are scheduled to receive one during the study period
- Individuals who are pregnant or breastfeeding, or women of childbearing potential (WOCBP) who do not agree to use highly effective contraception*
- A highly effective method of contraception is defined as one that results in a low failure rate of less than 1% per year when used consistently and correctly, and includes: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; and sexual abstinence.
- Individuals who have received other biologic agents within 5 half-lives prior to screening
- Individuals with a family member who has active tuberculosis, or who have a history of close contact with an individual with active tuberculosis
- Individuals with a major infection requiring antibiotic therapy within 30 days prior to screening
- Individuals with diabetes mellitus deemed uncontrolled by the investigator, or persistently uncontrolled severe hypertension (> 95th percentile for height and age)
- Individuals with a history of malignancy, or a history of solid organ, bone marrow, or corneal transplantation
- Individuals with a history of ocular surgery (e.g., cataract surgery) within 3 months prior to screening
- Individuals who have received intraocular or periocular corticosteroid injections within 30 days prior to screening
- Individuals with a history of ocular herpes simplex or herpes zoster infection
- Individuals with laboratory values evaluated during screening that meet any of the following criteria:
- Hemoglobin < 8.0 g/dL B. WBC < 4.0 × 10³/µL C. ANC < 1.0 × 10³/µL D. Platelet count < 100 × 10³/µL E. AST or ALT > 2 × ULN
- Individuals weighing less than 15 kg
- Individuals otherwise deemed unsuitable for study participation in the judgment of the investigator
- [Retrospective / Prospective Cohort-Specific Criteria]
- Inability to confirm disease activity (e.g., SUN grading) at the initial start of adalimumab treatment and subsequent treatment response via medical record review.
- Patients whose adalimumab dosage has been tapered to near-discontinuation (i.e., dosing intervals substantially exceeding once every 4 weeks) or for whom the treating physician deems the standard maintenance regimen (once every 2 weeks) clinically inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Adalimumab in Pediatric Non-Infectious Uveitis: A Multicenter Ambispective Single-Arm Clinical Trial
This study aims to evaluate the clinical efficacy and safety of adalimumab in pediatric non-infectious uveitis and to generate domestic real-world evidence (RWE), thereby establishing a clinical foundation for label expansion and reimbursement coverage.
Read the detailed description
Background: Although anti-TNFα agents play a crucial role globally in managing refractory non-infectious uveitis, adalimumab was removed from the approved indication for pediatric uveitis in South Korea several years ago-unlike adult uveitis-making domestic prescription exceptionally difficult. Meanwhile, indications for pediatric idiopathic arthritis and pediatric Crohn's disease remain approved domestically, highlighting an urgent need to establish objective evidence to resolve this regulatory discrepancy. Furthermore, as a substantial number of pediatric patients in Korea are already receiving off-label, non-reimbursed adalimumab treatment, their real-world data serve both as evidence of efficacy and safety and as direct proof of this institutional imbalance.
- Conditions
- Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Panuveitis
- Being tested
- Adalimumab PFS and Pen
- Keywords
- Adalimumab, Pediatric Uveitis, Non-infectious Uveitis, Anti-TNF Alpha, TNF Inhibitor, Ambispective Study
- Medical subject headings
- Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab PFS and PenDrug
Yuflyma Pen Inj. (recombinant adalimumab biosimilar, Celltrion) is administered via subcutaneous (SC) injection with weight-tiered dosing (<30 kg: 20 mg; ≥30 kg: 40 mg).
- Prospective Treatment-Naïve Cohort: Patients initiating adalimumab receive weight-tiered doses every other week (eow) for 52 weeks.
- Retrospective (Switch) Cohort: Patients previously maintained on adalimumab prior to study entry switch to Yuflyma at enrollment and receive weight-tiered maintenance doses once every two weeks (q2w) for at least 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Treatment-Naïve Cohort and | Experimental | Patients initiating adalimumab for the first time receive the investigational product (Yuflyma Pen Inj., subcutaneous adalimumab biosimilar) prospectively for 12 months (approximately 52 weeks) following enrollment. Receives: Drug: Adalimumab PFS and Pen |
| Retrospective (Switch) Cohort | Experimental | Patients previously maintained on adalimumab prior to study entry and requiring continued treatment for at least one additional year switch to the investigational product (Yuflyma Pen Inj., subcutaneous adalimumab biosimilar) at enrollment. Receives: Drug: Adalimumab PFS and Pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure Rate in the Prospective Treatment-Naïve Cohort
Percentage of participants meeting the criteria for treatment failure. Treatment failure is defined as any of the following: active intraocular inflammation (worsening anterior chamber cell grade, vitreous haze, or new chorioretinal lesions), lack of clinical efficacy requiring addition of new systemic immunosuppressive agents, inability to taper concomitant systemic corticosteroids to target maintenance levels, or discontinuation of the investigational product due to lack of efficacy or unacceptable toxicity.
Measured: Up to 12 months after adalimumab initiation
Change from Baseline in Medically Important Infections (MIIS) in the Prospective Treatment-Naïve Cohort
Total count and incidence rate of Medically Important Infections (defined as opportunistic infections, infections requiring intravenous antimicrobial therapy, or infections resulting in hospitalization or death) observed per participant. The change is calculated as the incidence during the 12-month post-initiation period compared to the pre-baseline reference status.
Measured: Baseline and 12 months after adalimumab initiation
Secondary outcomes (8)
Treatment Failure Rate in the Retrospective (Switch) Cohort
Percentage of participants who experience treatment failure following switch to the investigational product. Treatment failure is defined as active intraocular inflammation, necessity to escalate therapy or introduce unpermitted rescue therapies, or drug discontinuation due to lack of efficacy or adverse events.
Measured: Up to 12 months post-switch to the investigational product
Relapse-Free Survival Rate in the Retrospective (Switch) Cohort
Percentage of participants maintaining clinical inactive disease without uveitis recurrence after achieving initial clinical response, estimated using Kaplan-Meier survival methodology at specified annual landmark intervals.
Measured: At 12, 24, and 36 months post-adalimumab initiation
Cumulative Incidence of Relapse and Management Strategies in the Retrospective (Switch) Cohort
Cumulative incidence of ocular relapse and the distribution of clinical management strategies implemented upon relapse, categorized as dose escalation, administration interval shortening (e.g., from every other week to weekly), or permanent treatment discontinuation.
Measured: Up to 36 months post-adalimumab initiation
Drug Survival Rate of Adalimumab in the Retrospective (Switch) Cohort
Percentage of participants remaining on adalimumab therapy over time without permanent treatment cessation, evaluated by Kaplan-Meier survival curves.
Measured: Up to 36 months post-adalimumab initiation
Time to Adalimumab Discontinuation in the Retrospective (Switch) Cohort
Median time (in months) from adalimumab initiation to permanent discontinuation of therapy due to any reason, including loss of response, remission, adverse events, or patient withdrawal.
Measured: Up to 36 months post-adalimumab initiation
Steroid-Sparing Success Rate in the Retrospective (Switch) Cohort (Pooled Analysis)
Percentage of participants achieving successful systemic steroid-sparing, defined as achieving disease inactivity with oral prednisone (or equivalent) tapered to $\le 0.1\text{ mg/kg/day}$ (or complete cessation) and topical glucocorticoids tapered to $\le 2\text{ drops/day/eye}$.
Measured: Up to 36 months post-adalimumab initiation
Change from Baseline in Systemic and Topical Corticosteroid Requirements in the Retrospective (Switch) Cohort
Quantitative reduction in daily systemic corticosteroid dose (mg/kg/day of prednisone equivalent) and change in daily frequency of topical ophthalmic corticosteroid instillations per affected eye.
Measured: Baseline (initial adalimumab start) and up to 36 months post-initiation
Cumulative Incidence of Cataract and Elevated Intraocular Pressure in the Retrospective (Switch) Cohort (Pooled Analysis)
Percentage of participants who develop new-onset or worsening cataract (requiring surgical intervention or clinically significant progression) or elevated intraocular pressure ($\text{IOP} > 21\text{ mmHg}$ or an increase $\ge 10\text{ mmHg}$ from baseline requiring hypotensive medication).
Measured: Up to 36 months post-adalimumab initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 Non-infectious Anterior UveitisStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This ambispective study comprises two cohorts receiving subcutaneous Yuflyma (adalimumab biosimilar): (1) Prospective Treatment-Naïve Cohort: Patients initiating adalimumab prospectively receive weight-tiered dosing (\<30 kg: 20 mg loading then 20 mg eow; ≥30 kg: 40 mg loading then 40 mg eow) for 52 weeks. Concomitant MTX and oral corticosteroids are permitted. (2) Retrospective (Switch) Cohort: Patients maintained on adalimumab for up to 36 months switch to Yuflyma at enrollment and receive maintenance dosing (q2w without loading) for ≥1 year. Pre-enrollment data are retrospectively collected. To mitigate immortal-time bias, baseline for both cohorts is aligned to the initial start date of adalimumab. Cohort status (prospective vs. retrospective) will serve as a stratification factor or covariate in statistical models to evaluate overall efficacy, safety, and domestic real-world evidence for label expansion.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913750
- Sponsor's protocol ID
- 2026-08-116
- Acronym
- PANDA-U
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly to protect patient privacy and comply with relevant personal information protection regulations. Summary data and study results will be made available through peer-reviewed publication.
Publications
Ramanan AV, Dick AD, Jones AP, McKay A, Williamson PR, Compeyrot-Lacassagne S, Hardwick B, Hickey H, Hughes D, Woo P, Benton D, Edelsten C, Beresford MW; SYCAMORE Study Group. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017 Apr 27;376(17):1637-1646. doi: 10.1056/NEJMoa1614160.
PubMed 28445659
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Adalimumab in Pediatric Non-Infectious Uveitis: A Multicenter Ambispective Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07913750
- Acronym / sponsor ID
- PANDA-U / 2026-08-116
- Conditions
- Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Panuveitis
- Keywords
- Adalimumab, Pediatric Uveitis, Non-infectious Uveitis, Anti-TNF Alpha, TNF Inhibitor, Ambispective Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Nov 2026 (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 study aims to evaluate the clinical efficacy and safety of adalimumab in pediatric non-infectious uveitis and to generate domestic real-world evidence (RWE), thereby establishing a clinical foundation for label expansion and reimbursement coverage.
Detailed description
Background: Although anti-TNFα agents play a crucial role globally in managing refractory non-infectious uveitis, adalimumab was removed from the approved indication for pediatric uveitis in South Korea several years ago-unlike adult uveitis-making domestic prescription exceptionally difficult. Meanwhile, indications for pediatric idiopathic arthritis and pediatric Crohn's disease remain approved domestically, highlighting an urgent need to establish objective evidence to resolve this regulatory discrepancy. Furthermore, as a substantial number of pediatric patients in Korea are already receiving off-label, non-reimbursed adalimumab treatment, their real-world data serve both as evidence of efficacy and safety and as direct proof of this institutional imbalance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This ambispective study comprises two cohorts receiving subcutaneous Yuflyma (adalimumab biosimilar): (1) Prospective Treatment-Naïve Cohort: Patients initiating adalimumab prospectively receive weight-tiered dosing (<30 kg: 20 mg loading then 20 mg eow; ≥30 kg: 40 mg loading then 40 mg eow) for 52 weeks. Concomitant MTX and oral corticosteroids are permitted. (2) Retrospective (Switch) Cohort: Patients maintained on adalimumab for up to 36 months switch to Yuflyma at enrollment and receive maintenance dosing (q2w without loading) for ≥1 year. Pre-enrollment data are retrospectively collected. To mitigate immortal-time bias, baseline for both cohorts is aligned to the initial start date of adalimumab. Cohort status (prospective vs. retrospective) will serve as a stratification factor or covariate in statistical models to evaluate overall efficacy, safety, and domestic real-world evidence for label expansion.
| Arm | Type | Receives |
|---|---|---|
| Prospective Treatment-Naïve Cohort and | Experimental | Drug: Adalimumab PFS and PenPatients initiating adalimumab for the first time receive the investigational product (Yuflyma Pen Inj., subcutaneous adalimumab biosimilar) prospectively for 12 months (approximately 52 weeks) following enrollment. |
| Retrospective (Switch) Cohort | Experimental | Drug: Adalimumab PFS and PenPatients previously maintained on adalimumab prior to study entry and requiring continued treatment for at least one additional year switch to the investigational product (Yuflyma Pen Inj., subcutaneous adalimumab biosimilar) at enrollment. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- For the Prospective New-User Cohort, verification of Inclusion Criteria 1 through 6 is required.
- For the Retrospective (Switch) Cohort, verification of Inclusion Criteria 1 through 7 is required.
- [Prospective De Novo Cohort]
- [Retrospective / Prospective Cohort] 6. Patients currently on maintenance therapy with adalimumab (including extended dosing intervals, such as every other week [Q2W] or every 3-4 weeks) who require at least 1 additional year of treatment.
- 7. Patients who agree to switch to the investigational product and adhere to a standard every-other-week (Q2W / once every 2 weeks) administration schedule at the time of study enrollment.
Key exclusion criteria (29 listed)
- For the Prospective New-User Cohort, verification of Exclusion Criteria 1 through 22 is required.
- For the Retrospective (Switch) Cohort, verification of Exclusion Criteria 1 through 24 is required.
- A highly effective method of contraception is defined as one that results in a low failure rate of less than 1% per year when used consistently and correctly, and includes: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; and sexual abstinence.
- [Retrospective / Prospective Cohort-Specific Criteria]
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 PFS and PenYuflyma Pen Inj. (recombinant adalimumab biosimilar, Celltrion) is administered via subcutaneous (SC) injection with weight-tiered dosing (<30 kg: 20 mg; ≥30 kg: 40 mg). * Prospective Treatment-Naïve Cohort: Patients initiating adalimumab receive weight-tiered doses every other week (eow) for 52 weeks. * Retrospective (Switch) Cohort: Patients previously maintained on adalimumab prior to study entry switch to Yuflyma at enrollment and receive weight-tiered maintenance doses once every two weeks (q2w) for at least 12 months. | Drug | Prospective Treatment-Naïve Cohort and, Retrospective (Switch) Cohort |
Primary outcome
Treatment Failure Rate in the Prospective Treatment-Naïve Cohort
Time frame: Up to 12 months after adalimumab initiation
Percentage of participants meeting the criteria for treatment failure. Treatment failure is defined as any of the following: active intraocular inflammation (worsening anterior chamber cell grade, vitreous haze, or new chorioretinal lesions), lack of clinical efficacy requiring addition of new systemic immunosuppressive agents, inability to taper concomitant systemic corticosteroids to target maintenance levels, or discontinuation of the investigational product due to lack of efficacy or unacceptable toxicity.
Change from Baseline in Medically Important Infections (MIIS) in the Prospective Treatment-Naïve Cohort
Time frame: Baseline and 12 months after adalimumab initiation
Total count and incidence rate of Medically Important Infections (defined as opportunistic infections, infections requiring intravenous antimicrobial therapy, or infections resulting in hospitalization or death) observed per participant. The change is calculated as the incidence during the 12-month post-initiation period compared to the pre-baseline reference status.
8 secondary outcomes
Treatment Failure Rate in the Retrospective (Switch) Cohort
Time frame: Up to 12 months post-switch to the investigational product
Relapse-Free Survival Rate in the Retrospective (Switch) Cohort
Time frame: At 12, 24, and 36 months post-adalimumab initiation
Cumulative Incidence of Relapse and Management Strategies in the Retrospective (Switch) Cohort
Time frame: Up to 36 months post-adalimumab initiation
Drug Survival Rate of Adalimumab in the Retrospective (Switch) Cohort
Time frame: Up to 36 months post-adalimumab initiation
Time to Adalimumab Discontinuation in the Retrospective (Switch) Cohort
Time frame: Up to 36 months post-adalimumab initiation
Steroid-Sparing Success Rate in the Retrospective (Switch) Cohort (Pooled Analysis)
Time frame: Up to 36 months post-adalimumab initiation
Change from Baseline in Systemic and Topical Corticosteroid Requirements in the Retrospective (Switch) Cohort
Time frame: Baseline (initial adalimumab start) and up to 36 months post-initiation
Cumulative Incidence of Cataract and Elevated Intraocular Pressure in the Retrospective (Switch) Cohort (Pooled Analysis)
Time frame: Up to 36 months post-adalimumab initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Results publication: PubMed 28445659Ramanan AV, Dick AD, Jones AP, McKay A, Williamson PR, Compeyrot-Lacassagne S, Hardwick B, Hickey H, Hughes D, Woo P, Benton D, Edelsten C, Beresford MW; SYCAMORE Study Group. Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis. N Engl J Med. 2017 Apr 27;376(17):1637-1646. doi: 10.1056/NEJMoa1614160.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly to protect patient privacy and comply with relevant personal information protection regulations. Summary data and study results will be made available through peer-reviewed publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adalimumab PFS and Pen in people with Non-infectious Anterior Uveitis and Non-infectious Intermediate Uveitis, run by Samsung Medical Center at 1 site in South Korea.
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 11 inclusion and 29 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mieun kim (+82-2-2148-7664, mieun2728.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure Rate in the Prospective Treatment-Naïve Cohort (time frame: Up to 12 months after adalimumab initiation). 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?
On the ClinicalTrials.gov record for NCT07913750, 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 3 Nov 2026.