Comparison · NCT03283085-727e8e8d
CD: Ontamalimab 25 mg Then 75 mg vs CD: Ontamalimab 75 mg: Number of Participants With Crohn's Disease 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. CD: Ontamalimab 25 mg Then 75 mg vs CD: Ontamalimab 75 mg: Number of Participants With Crohn's Disease With Treatment Response Over Time. Trial comparisons, record NCT03283085-727e8e8d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03283085-727e8e8d
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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 | 0.61 | 1 | wilson | |
| Risk in group 2 | 0.923 | 0.667 | 0.986 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0769 | -0.318 | 0.333 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.926 | 1.27 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on CD: Ontamalimab 25 mg Then 75 mg than on CD: Ontamalimab 75 mg | 13 | 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 | CD: 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. | 6 | 6 | OG000 |
| Group 2 | CD: Ontamalimab 75 mg | Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years. | 12 | 13 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Crohn's Disease With Treatment Response Over Time
- Description
Treatment response over time=Crohn's Disease Activity Index(CDAI)score that has decreased ≥100 points and/or simple endoscopic score for Crohn's disease(SES-CD)that has decreased by ≥25%,both compared to baseline value for induction studies.SES-CD is simple scoring system with 4 endoscopic variables measured in same 5 ileocolonic segments as CD index of severity. Overall values on SES-CD range from 0-56,higher values=more severe disease.4 endoscopic variables are scored from 0-3 in each bowel segment:ileum,right/transverse/left colon,rectum. Presence \& size of ulcers(none=0;diameter 0.1-0.5centimeter(cm)=1;0.5-2cm=2;\>2cm=3);extent of ulcerated surface(none=0;\<10%=1;10%-30%=2; \>30%= 3);extent of affected surface(none=0;\<50%=1;50%-75%=2;\>75%=3);Presence \& type of narrowing (none=0;single can be passed=1;multiple can be passed=2;cannot be passed=3).
- Time frame
- Up to 5.79 years
- Population
FAS included all participants in randomized set who received at least 1 dose of IP in the SHP647-304 study. With implementation of protocol amendment 4 this became a single arm study with all participants receiving 75 mg ontamalimab. Hence, only those CD participants who were receiving ontamalimab 75mg Q4W and participating in amendment 4 of the protocol were analyzed. Overall number analyzed is the number of CD 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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