Comparison · NCT02911116-bb0d0bed
Cohort 1 (Subcutaneous Only) vs Cohort 2 (IV and Subcutaneous): Number of Participants Experiencing a Treatment Response by Week 16
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Cohort 1 (Subcutaneous Only) vs Cohort 2 (IV and Subcutaneous): Number of Participants Experiencing a Treatment Response by Week 16. Trial comparisons, record NCT02911116-bb0d0bed. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02911116-bb0d0bed
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.51 | 1 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.49 | 0.658 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cohort 1 (Subcutaneous Only) | Subcutaneous injections of Ustekinumab at baseline.~Ustekinumab: Subcutaneous Injection | 4 | 4 | OG000 |
| Group 2 | Cohort 2 (IV and Subcutaneous) | Initial IV infusion of ustekinumab at baseline followed by one subcutaneous injection at Week 8. In participants who demonstrate an allergic reaction to the baseline IV infusion, the second dose at Week 8 can also be administered as an IV infusion instead of a subcutaneous injection.~Ustekinumab: Subcutaneous Injection~Ustekinumab: Intravenous Infusion | 2 | 2 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Experiencing a Treatment Response by Week 16
- Description
The primary outcome is the number of participants in each cohort who experience a treatment response by Week 16. Treatment response is defined as experiencing all of the following for both/eligible eyes: no active inflammatory chorioretinal lesion and/or absent or decreased retinal vascular leakage; ≤ 0.5+ anterior chamber (AC) cells; ≤ 0.5+ vitreous haze.
- Time frame
- Baseline to Week 16
- Population
All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
Source ClinicalTrials.gov
Trial
- Title
- Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study)
- NCT number
- NCT02911116
- Phases
- PHASE2
- Conditions
- Uveitis
- Interventions
- Ustekinumab, Ustekinumab
- Lead sponsor
- National Eye Institute (NEI)
- Results first posted
- 2021-03-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02911116?tab=results
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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