Trial · NCT07913750
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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). |
| Other | Integrated Assessment of Adverse Events Across the Cumulative Exposure Period | Up to 48 months (covering up to 36 months retrospective exposure plus 12 months prospective study period) | Number, incidence rates, and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) assessed per Common Terminology Criteria for Adverse Events (CTCAE) criteria across the combined follow-up duration. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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