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Comparison · NCT03828019-deaths

Adalimumab (ADA) vs Conventional Immunosuppression (CON): deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Adalimumab (ADA) vs Conventional Immunosuppression (CON): deaths from any cause. Trial comparisons, record NCT03828019-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03828019-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0329wilson
Risk in group 2000.0337wilson
Risk difference, group 1 minus group 20-0.03370.0329newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Adalimumab (ADA)
Adalimumab administered by subcutaneous injection at dosage and frequency specified below; total duration of treatment is 12 months.~Adults (≥ 18 years of age) and adolescents ≥30 kg: 80 mg as initial dose; one week later by 40 mg then 40 mg every two weeks. Adolescents \<30 kg: 40 mg as initial dose; one week later 20 mg then 20 mg every 2 weeks.~Adalimumab (ADA): Adalimumab is a fully-human monoclonal antibody to TNF-α, which is approved by the U.S. FDA for the treatment of non-infectious intermediate, posterior, and panuveitides in adults and children 2 years of age and older.
0113EG000
Group 2Conventional Immunosuppression (CON)
Conventional immunosuppressive agent selected by study ophthalmologist at dose and frequency specified below;12 month treatment duration.~Azathioprine: initially 2 mg/kg/day; max dose 200 mg/day. Methotrexate initially 15mg/wk; max dose 25 mg/wk. Mycophenolate initially 1 gm BID; max dose1.5 gm BID. Cyclosporine (Sandimmune - dose 2.5 mg/kg BID and Neoral dose 2 mg/kg BID. Tacrolimus initially 1 mg BID; max dose 3 mg BID.~Conventional immunosuppression (CON): The study ophthalmologist will select amongst the permissible drugs (methotrexate, mycophenolate mofetil or azathioprine for antimetabolites; cyclosporine or tacrolimus for calcineurin inhibitors) taking into account the side effect profile of each drug with respect to subject's clinical situation.
0110EG001

Harm

What it counts
Total, all-cause mortality
Time frame
From enrollment through the 12 months visit (end of treatment) non-serious events were reported on the monthly or bimonthly case report form. Non serious events were analyzed by counting persons who ever reported the event over the 12 month study. Serious adverse events were reported by the clinical site as the event occurred or the site became aware of the event. Adverse event information was available only for participants (ADA N = 113, CID N= 110) who continued in the study past enrollment.

Source ClinicalTrials.gov

Trial

Title
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
NCT number
NCT03828019
Phases
PHASE3
Conditions
Uveitis
Interventions
Adalimumab (ADA), Conventional immunosuppression (CON)
Lead sponsor
JHSPH Center for Clinical Trials
Results first posted
2025-05-16

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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