Comparison · NCT03107793-4f170f1c
Maintenance Period: Treat to Target vs Maintenance Period: Routine Care: Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48
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. Maintenance Period: Treat to Target vs Maintenance Period: Routine Care: Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48. Trial comparisons, record NCT03107793-4f170f1c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03107793-4f170f1c
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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 | 0.858 | 0.806 | 0.898 | wilson | |
| Risk in group 2 | 0.81 | 0.753 | 0.856 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0485 | -0.0214 | 0.118 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.975 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 1.42 | 0.857 | 2.36 | log | |
| Number needed to treat, for one more participant with the outcome on Maintenance Period: Treat to Target than on Maintenance Period: Routine Care | 20.6 | from the risk difference interval | the interval includes no difference |
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 | Maintenance Period: Treat to Target | Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study. | 188 | 219 | OG000 |
| Group 2 | Maintenance Period: Routine Care | Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment. | 179 | 221 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48
- Description
An adverse event is any untoward medical event that occurs in participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
- Time frame
- Up to Week 48
- Population
- FRAS included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized.
Source ClinicalTrials.gov
Trial
- Title
- Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
- NCT number
- NCT03107793
- Phases
- PHASE3
- Conditions
- Crohn Disease
- Interventions
- Ustekinumab
- Lead sponsor
- Janssen-Cilag Ltd.
- Results first posted
- 2021-05-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03107793?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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