Trial · NCT03828019
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
NCT03828019, Phase 3, Completed, JHSPH Center for Clinical Trials; results first posted 2025-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adalimumab vs. Conventional Immunosuppression for Uveitis Trial. Trials, record NCT03828019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03828019
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
- NCT number
- NCT03828019
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 227 participants, actual
- Lead sponsor
- JHSPH Center for Clinical Trials
- Conditions
- Uveitis
- Interventions
- Adalimumab (ADA), Conventional immunosuppression (CON)
- First posted
- 2019-02-04
- Last updated
- 2025-05-16
- Results first posted
- 2025-05-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization | 6 months | Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart while on \<= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. Results were reported at 6 months (primary outcome) and 12 months (secondary outcome). |
| Secondary | Corticosteroid-sparing Treatment Success Within the First 12 Months After Randomization | 12 months | Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart while on \<= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. Results were reported at 6 months (primary outcome) and 12 months (secondary outcome). |
| Secondary | Corticosteroid Discontinuation Success by 6 Months | 6 months | Corticosteroid discontinuation success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart after discontinuing corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. Results were reported at 6 months and 12 months. |
| Secondary | Corticosteroid Discontinuation Success by 12 Months | 12 months | Corticosteroid discontinuation success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart after discontinuing corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. Results were reported at 6 months and 12 months. |
| Secondary | Corticosteroid Exposure Over 12 Months | 12 months | Corticosteroid dose was collected at baseline and months 1,2,3,4,5,6,8,10, and 12. Mean corticosteroid dose per day was estimated with a negative binomial model at 12 months. |
| Secondary | Best Corrected Visual Acuity Change at 12 Months | 12 months | Mean change in best-corrected visual acuity from baseline to 12 months. Participants' visual acuity was measured by certified examiners with best refractive correction in place. Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity (85 letters is 20/20 vision). Visual acuity data was collected at baseline and months 1,2,3,4,5,6,8,10, and 12 and estimated at 12 months with a mixed model. |
| Secondary | Macular Edema Over 12 Months of Follow up | 12 months | Macular edema is defined as central retinal thickness greater than or equal to 300 micrometers as measured by a masked grader's review of OCT images. Greater retinal thickness is associated with poorer vision. Outcome measure is the odds ratio comparing macular edema at 12 months to baseline macular edema. Macular edema was measured at baseline and months 3, 6, and 12. The odds ratio at 12 months was estimated with a mixed model. |
| Secondary | Incidence of Infections at 12 Months | 12 months | Incidence of infections over 12 months of follow-up. Participants were asked about occurrences since the previous visit of infections requiring antibiotic or antiviral treatment. Data was collected at months 1,2,3,4,5,6,8,10, and 12. The rate of infections at 12 months was estimated with a negative binomial model. |
| Secondary | Elevated Levels of AST or ALT (Hepatoxicity) by 12 Months. | 12 months | Cumulative percent of participants having elevated levels of aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than twice the upper level of normal by 12 months. Elevated levels of AST and ALT may indicate decline in liver function. Lab values of AST and ALT were measured at baseline and months 1,2,3,4,5,6,8,10, and 12 and the cumulative percent of participants with elevated lab values by 12 months was estimated by Kaplan Meier methods. |
| Secondary | Elevated Creatine (Nephrotoxicity) by 12 Months | 12 months | Cumulative percent of participants having elevated creatine values (creatine greater than 30% above baseline or creatine \> 1.5 mg/dL) by 12 months. Increases in creatine levels may indicate decreased kidney function. Lab values of creatine were measured at baseline and months 1,2,3,4,5,6,8,10, and 12 and the cumulative percent of participants with elevated creatine at 12 months was estimated by Kaplan Meier methods. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization | 6 months | Participants with follow-up data through the 6 month visit or had an event (corticosteroid sparing success) before they were lost to follow-up | Cumulative proportion of participants | NUMBER |
| SECONDARY | Corticosteroid-sparing Treatment Success Within the First 12 Months After Randomization | 12 months | Participants with follow-up data through the 12 month visit or had an event (corticosteroid sparing success) before they were lost to follow-up | Cumulative proportion of participants | NUMBER |
| SECONDARY | Corticosteroid Discontinuation Success by 6 Months | 6 months | Participants with follow-up through the 6 months visit or had an event (discontinued corticosteroids) before lost to follow-up | Cumulative proportion of participants | NUMBER |
| SECONDARY | Corticosteroid Discontinuation Success by 12 Months | 12 months | Cumulative proportion of participants | NUMBER | |
| SECONDARY | Corticosteroid Exposure Over 12 Months | 12 months | Participants with follow up treatment data | mg/day of steroid use over 12 months | MEAN |
| SECONDARY | Best Corrected Visual Acuity Change at 12 Months | 12 months | All participants | Standard letters ETDRS eye chart | MEAN |
| SECONDARY | Macular Edema Over 12 Months of Follow up | 12 months | Participants with follow up retinal thickness data at enrollment and the 12 month visit | Odds ratio | NUMBER |
| SECONDARY | Incidence of Infections at 12 Months | 12 months | Participants with follow up after the baseline visit | Number of infections per person year | NUMBER |
| SECONDARY | Elevated Levels of AST or ALT (Hepatoxicity) by 12 Months. | 12 months | Participants with follow-up that did not have elevated levels of AST or ALT at baseline | Cumulative percent of participants | NUMBER |
| SECONDARY | Elevated Creatine (Nephrotoxicity) by 12 Months | 12 months | Participants with follow-up that did not have elevated creatine at the time of enrollment | Cumulative percent of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization | Adalimumab (ADA) | 0.69 | 95% Confidence Interval 0.60 to 0.77 | Cumulative proportion of participants | |
| Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization | Conventional Immunosuppression (CON) | 0.54 | 95% Confidence Interval 0.44 to 0.64 | Cumulative proportion of participants | |
| Corticosteroid-sparing Treatment Success Within the First 12 Months After Randomization | Adalimumab (ADA) | 0.86 | 95% Confidence Interval 0.78 to 0.92 | Cumulative proportion of participants | |
| Corticosteroid-sparing Treatment Success Within the First 12 Months After Randomization | Conventional Immunosuppression (CON) | 0.77 | 95% Confidence Interval 0.67 to 0.84 | Cumulative proportion of participants | |
| Corticosteroid Discontinuation Success by 6 Months | Adalimumab (ADA) | 0.15 | 95% Confidence Interval 0.09 to 0.24 | Cumulative proportion of participants | |
| Corticosteroid Discontinuation Success by 6 Months | Conventional Immunosuppression (CON) | 0.11 | 95% Confidence Interval 0.06 to 0.18 | Cumulative proportion of participants | |
| Corticosteroid Discontinuation Success by 12 Months | Adalimumab (ADA) | 0.55 | 95% Confidence Interval 0.45 to 0.64 | Cumulative proportion of participants | |
| Corticosteroid Discontinuation Success by 12 Months | Conventional Immunosuppression (CON) | 0.40 | 95% Confidence Interval 0.30 to 0.50 | Cumulative proportion of participants | |
| Corticosteroid Exposure Over 12 Months | Adalimumab (ADA) | 11.8 | 95% Confidence Interval 10.5 to 13.2 | mg/day of steroid use over 12 months | |
| Corticosteroid Exposure Over 12 Months | Conventional Immunosuppression (CON) | 13.8 | 95% Confidence Interval 12.3 to 15.4 | mg/day of steroid use over 12 months |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adalimumab (ADA) | 114 | 214 |
| Overall Study | STARTED | Conventional Immunosuppression (CIN) | 113 | 220 |
| Overall Study | Primary Outcome 6 Months | Adalimumab (ADA) | 112 | 211 |
| Overall Study | Primary Outcome 6 Months | Conventional Immunosuppression (CIN) | 105 | 204 |
| Overall Study | COMPLETED | Adalimumab (ADA) | 109 | 206 |
| Overall Study | COMPLETED | Conventional Immunosuppression (CIN) | 98 | 190 |
| Overall Study | NOT COMPLETED | Adalimumab (ADA) | 5 | 8 |
| Overall Study | NOT COMPLETED | Conventional Immunosuppression (CIN) | 15 | 30 |
Source ClinicalTrials.gov
Adverse events108
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 | Epiretinal membrane | Eye disorders | Adalimumab (ADA) | 17 | 113 | |
| other | Epiretinal membrane | Eye disorders | Conventional Immunosuppression (CON) | 20 | 110 | |
| other | Abdominal pain | Gastrointestinal disorders | Adalimumab (ADA) | 46 | 113 | |
| other | Abdominal pain | Gastrointestinal disorders | Conventional Immunosuppression (CON) | 48 | 110 | |
| other | mouth ulcer | Gastrointestinal disorders | Adalimumab (ADA) | 21 | 113 | |
| other | mouth ulcer | Gastrointestinal disorders | Conventional Immunosuppression (CON) | 23 | 110 | |
| other | Diahrrhea | Gastrointestinal disorders | Adalimumab (ADA) | 42 | 113 | |
| other | Diahrrhea | Gastrointestinal disorders | Conventional Immunosuppression (CON) | 46 | 110 | |
| other | Gingival swelling | Gastrointestinal disorders | Adalimumab (ADA) | 23 | 113 | |
| other | Gingival swelling | Gastrointestinal disorders | Conventional Immunosuppression (CON) | 24 | 110 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adalimumab (ADA) | 0 | 113 |
| Total, all-cause mortality | Conventional Immunosuppression (CON) | 0 | 110 |
| Total, other adverse events | Adalimumab (ADA) | 108 | 113 |
| Total, other adverse events | Conventional Immunosuppression (CON) | 104 | 110 |
| Total, serious adverse events | Adalimumab (ADA) | 16 | 113 |
| Total, serious adverse events | Conventional Immunosuppression (CON) | 13 | 110 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adalimumab (ADA) vs Conventional Immunosuppression (CON): deaths from any cause | Trial comparisons |
| Adalimumab (ADA) vs Conventional Immunosuppression (CON): serious adverse events | 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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