Comparison · NCT03283085-ecaf3808
UC: Ontamalimab 25 mg Then 75 mg vs UC: Ontamalimab 75 mg: Number of Participants With Ulcerative Colitis With Treatment Response Over Time
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. UC: Ontamalimab 25 mg Then 75 mg vs UC: Ontamalimab 75 mg: Number of Participants With Ulcerative Colitis With Treatment Response Over Time. Trial comparisons, record NCT03283085-ecaf3808. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03283085-ecaf3808
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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 | 0.967 | 0.917 | 0.987 | wilson | |
| Risk in group 2 | 0.97 | 0.925 | 0.988 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00326 | -0.0558 | 0.0458 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.997 | 0.953 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.899 | 0.22 | 3.68 | log | |
| Number needed to treat, for one fewer participant with the outcome on UC: Ontamalimab 25 mg Then 75 mg than on UC: Ontamalimab 75 mg | 307 | 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 | UC: Ontamalimab 25 mg Then 75 mg | Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years. | 116 | 120 | OG000 |
| Group 2 | UC: Ontamalimab 75 mg | Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years. | 129 | 133 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Ulcerative Colitis With Treatment Response Over Time
- Description
Treatment response over time was defined as clinical composite score that has decreased by greater than or equal to (≥2) points and ≥30 percentage (%), with an accompanying decrease in the sub score for rectal bleeding (RB) ≥1 point or a subscore for RB ≤ 1, and/or composite score that has decreased by ≥30% and ≥3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease. With the implementation of amendment 4 of the protocol the study became a single arm study with all participants receiving the 75 mg dose of ontamalimab. Hence, only those UC participants who were receiving the 75 mg dose of ontamalimab every 4 weeks and participating in amendment 4 of the protocol were analyzed in this outcome measure.
- Time frame
- Up to 5.79 years
- Population
Full Analysis Set (FAS) included all participants in the randomized set who received at least 1 dose of IP in the SHP647-304 study. Overall number analyzed is the number of UC participants with data available for analyses.
Source ClinicalTrials.gov
Trial
- Title
- A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
- NCT number
- NCT03283085
- Phases
- PHASE3
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Interventions
- 25 mg Ontamalimab, 75 mg Ontamalimab
- Lead sponsor
- Shire
- Results first posted
- 2024-06-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03283085?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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