Trial · NCT07913750
Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
NCT07913750, Not applicable, Not yet recruiting, Samsung Medical Center
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation. Trials, record NCT07913750. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
- NCT number
- NCT07913750
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Samsung Medical Center
- Conditions
- Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Panuveitis
- Interventions
- Adalimumab PFS and Pen
- First posted
- 2026-11-03
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Failure Rate in the Prospective Treatment-Naïve Cohort | 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. |
| Primary | Change from Baseline in Medically Important Infections (MIIS) in the Prospective Treatment-Naïve Cohort | 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. |
| Secondary | Treatment Failure Rate in the Retrospective (Switch) Cohort | Up to 12 months post-switch to the investigational product | 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. |
| Secondary | Relapse-Free Survival Rate in the Retrospective (Switch) Cohort | At 12, 24, and 36 months post-adalimumab initiation | 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. |
| Secondary | Cumulative Incidence of Relapse and Management Strategies in the Retrospective (Switch) Cohort | Up to 36 months post-adalimumab initiation | 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. |
| Secondary | Drug Survival Rate of Adalimumab in the Retrospective (Switch) Cohort | Up to 36 months post-adalimumab initiation | Percentage of participants remaining on adalimumab therapy over time without permanent treatment cessation, evaluated by Kaplan-Meier survival curves. |
| Secondary | Time to Adalimumab Discontinuation in the Retrospective (Switch) Cohort | Up to 36 months post-adalimumab initiation | 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. |
| Secondary | Steroid-Sparing Success Rate in the Retrospective (Switch) Cohort (Pooled Analysis) | Up to 36 months post-adalimumab initiation | 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 $\\le 2\\text{ drops/day/eye}$. |
| Secondary | Change from Baseline in Systemic and Topical Corticosteroid Requirements in the Retrospective (Switch) Cohort | Baseline (initial adalimumab start) and up to 36 months post-initiation | 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. |
| Secondary | Cumulative Incidence of Cataract and Elevated Intraocular Pressure in the Retrospective (Switch) Cohort (Pooled Analysis) | Up to 36 months post-adalimumab initiation | 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). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28445659 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07913750
GET https://conductscience.org/api/trials/v1/NCT07913750/registered