Comparison · NCT04882072-9fd082a5
OLE: Ustekinumab Then Ustekinumab vs OLE: Placebo Then Ustekinumab: Number of Participants With Positive Anti-ustekinumab Antibodies Through End of OLE Period
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. OLE: Ustekinumab Then Ustekinumab vs OLE: Placebo Then Ustekinumab: Number of Participants With Positive Anti-ustekinumab Antibodies Through End of OLE Period. Trial comparisons, record NCT04882072-9fd082a5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04882072-9fd082a5
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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 | 0 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.561 | 0.39 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| 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
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | OLE: Ustekinumab Then Ustekinumab | Participants who had relapse during the double-blind period, received rescue medication of \>=doubled oral GC dose. These participants were assessed whether they achieved remission at the next scheduled dose administration visit (OL Week 0) from the relapse to enter OLE period and then they received ustekinumab 90 mg IV infusion at OL Week 0 followed by ustekinumab 90 mg SC injection at OL Week 8 and thereafter q8w till end of OLE period (maximum exposure: 48.1 weeks). Participants with no remission status received ustekinumab IV infusion at OL Week 0 and thereafter q8w till end of OLE period (maximum exposure 48.1 weeks). Rest of the participants entered OLE period after end of double-blind period and received ustekinumab 90 mg SC injection (maintenance dosing) q8w from OL Week 0 (maximum exposure: 48.1 weeks). | 0 | 6 | OG001 |
| Group 2 | OLE: Placebo Then Ustekinumab | Participants who had relapse during the double-blind period, received rescue medication of \>=doubled oral GC dose. These participants were assessed whether they achieved remission at the next scheduled dose administration visit (OL Week 0) from the relapse to enter OLE period and received ustekinumab 90 mg IV infusion at OL Week 0 followed by ustekinumab 90 mg SC injection at OL Week 8 and thereafter q8w in OLE period (maximum exposure: 48.1 weeks). Rest of the participants entered OLE period after end of double blind period and then they received ustekinumab 90 mg SC injection (maintenance dosing) q8w from OL Week 0 (maximum exposure: 48.1 weeks). Participants who received placebo (up to 8.1 weeks) in double-blind period received ustekinumab 90 mg SC injection (maintenance dosing) q8w from OL Week 0 till end of OLE period (maximum exposure: 48.1 weeks). | 0 | 3 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Positive Anti-ustekinumab Antibodies Through End of OLE Period
- Description
- Number of participants with positive anti-ustekinumab antibodies were reported.
- Time frame
- From OL Week 0 up to end of OLE period (up to 63.1 weeks)
- Population
The immunogenicity analysis set was defined as all participants who received at least 1 dose of ustekinumab and had at least 1 postdose valid immunogenicity data. In ustekinumab arm N included all participants who were initially randomized to ustekinumab arm.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)
- NCT number
- NCT04882072
- Phases
- PHASE3
- Conditions
- Takayasu Arteritis
- Interventions
- Ustekinumab, Placebo, Glucorticoid Taper Regimen
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Results first posted
- 2024-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04882072?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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