Trial · NCT01124838
Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis
NCT01124838, Phase 3, Completed, AbbVie (prior sponsor, Abbott); results first posted 2016-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis. Trials, record NCT01124838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01124838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis
- NCT number
- NCT01124838
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 261 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
- Uveitis
- Interventions
- Adalimumab, Prednisone, Placebo
- First posted
- 2010-05-17
- Last updated
- 2021-07-07
- Other registries' IDs
- eudract:2009-016008-22
- Results first posted
- 2016-06-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Treatment Failure on or After Week 2 | From Baseline until end of study (up to 80 weeks) | Treatment failure was defined by the occurrence of a uveitis flare (the inability to maintain disease control). To be considered treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye at Week 2 or all other visits: * New active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesions relative to Baseline * 2-step increase relative to Baseline in anterior chamber cell grade or vitreous haze grade * Worsening of best corrected visual acuity by ≥ 15 letters relative to baseline. Time to treatment failure was analyzed using the Kaplan-Meier method. Dropouts for reasons other than treatment failure at any time during the study were censored at the drop out date. Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan. |
| Secondary | Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit | Baseline and at the Final/Early Termination Visit (up to 80 weeks) | Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0 = \< 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = \> 50 cells. |
| Secondary | Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up to 80 weeks) | Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria: Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured. |
| Secondary | Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up to 80 weeks) | Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. |
| Secondary | Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2 | From Baseline until the Final Visit (up to 80 weeks) | Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema. OCT evidence of macular edema on or after Week 2 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out. |
| Secondary | Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit. | Baseline and Final/Early Termination Visit (up to 80 weeks) | Central retinal thickness was measured using OCT and assessed by a central reader. |
| Secondary | Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up 80 weeks) | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. |
| Secondary | Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up 80 weeks) | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. |
| Secondary | Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up 80 weeks) | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The near vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. |
| Secondary | Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up 80 weeks) | The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated form the answers to 2 eye pain questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Treatment Failure on or After Week 2 | From Baseline until end of study (up to 80 weeks) | The intent-to-treat (ITT) population which included all randomized participants; 3 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues. | months | MEDIAN |
| SECONDARY | Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit | Baseline and at the Final/Early Termination Visit (up to 80 weeks) | Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up to 80 weeks) | Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up to 80 weeks) | Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used. | logMAR | MEAN |
| SECONDARY | Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2 | From Baseline until the Final Visit (up to 80 weeks) | Intent to treat population with no macular edema at Baseline | months | MEDIAN |
| SECONDARY | Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit. | Baseline and Final/Early Termination Visit (up to 80 weeks) | Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used. | percent change | MEAN |
| SECONDARY | Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up 80 weeks) | Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up 80 weeks) | Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up 80 weeks) | Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit | Baseline and Final/Early Termination Visit (up 80 weeks) | Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Treatment Failure on or After Week 2 | Main Study: Placebo | 8.3 | Inter-Quartile Range 3.0 to NA | months | |
| Time to Treatment Failure on or After Week 2 | Main Study: Adalimumab | NA | Inter-Quartile Range 4.7 to NA | months | |
| Time to Treatment Failure on or After Week 2 | Integrated Study (Main + Japan Sub-study): Placebo | 5.6 | Inter-Quartile Range 2.6 to NA | months | |
| Time to Treatment Failure on or After Week 2 | Integrated Study (Main + Japan Sub-study): Adalimumab | NA | Inter-Quartile Range 3.9 to NA | months | |
| Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit | Main Study: Placebo | Left eye | 0.57 | Standard Deviation 1.001 | units on a scale |
| Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit | Main Study: Adalimumab | Left eye | 0.41 | Standard Deviation 0.969 | units on a scale |
| Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit | Integrated Study (Main + Japan Sub-study): Placebo | Left eye | 0.61 | Standard Deviation 1.005 | units on a scale |
| Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit | Integrated Study (Main + Japan Sub-study): Adalimumab | Left eye | 0.46 | Standard Deviation 0.996 | units on a scale |
| Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit | Main Study: Placebo | Right eye | 0.53 | Standard Deviation 0.963 | units on a scale |
| Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit | Main Study: Adalimumab | Right eye | 0.40 | Standard Deviation 0.927 | units on a scale |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 130 | |
| Overall Study | STARTED | Adalimumab | 131 | |
| Overall Study | Enrolled in Main Study | Placebo | 114 | |
| Overall Study | Enrolled in Main Study | Adalimumab | 115 | |
| Overall Study | Enrolled in Japan Sub-study | Placebo | 16 | |
| Overall Study | Enrolled in Japan Sub-study | Adalimumab | 16 | |
| Overall Study | COMPLETED | Placebo | 112 | |
| Overall Study | COMPLETED | Adalimumab | 116 | |
| Overall Study | NOT COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Adalimumab | 15 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | CYSTOID MACULAR OEDEMA | Eye disorders | Placebo | 7 | 130 | |
| other | CYSTOID MACULAR OEDEMA | Eye disorders | Adalimumab | 7 | 131 | |
| other | DRY EYE | Eye disorders | Placebo | 8 | 130 | |
| other | DRY EYE | Eye disorders | Adalimumab | 5 | 131 | |
| other | EYE PAIN | Eye disorders | Placebo | 6 | 130 | |
| other | EYE PAIN | Eye disorders | Adalimumab | 9 | 131 | |
| other | UVEITIS | Eye disorders | Placebo | 9 | 130 | |
| other | UVEITIS | Eye disorders | Adalimumab | 6 | 131 | |
| other | VISUAL ACUITY REDUCED | Eye disorders | Placebo | 10 | 130 | |
| other | VISUAL ACUITY REDUCED | Eye disorders | Adalimumab | 6 | 131 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Adalimumab | ||
| Total, other adverse events | Placebo | 78 | 130 |
| Total, other adverse events | Adalimumab | 88 | 131 |
| Total, serious adverse events | Placebo | 10 | 130 |
| Total, serious adverse events | Adalimumab | 8 | 131 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Adalimumab vs Placebo: serious adverse events |
Source Trial comparisons
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.
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