Comparison · NCT03945019-5be04ca3
CT-P13 SC 120 mg vs Placebo: Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. CT-P13 SC 120 mg vs Placebo: Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54. Trial comparisons, record NCT03945019-5be04ca3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03945019-5be04ca3
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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 | 0.567 | 0.503 | 0.629 | wilson | |
| Risk in group 2 | 0.313 | 0.234 | 0.403 | wilson | |
| Risk difference, group 1 minus group 2 | 0.255 | 0.143 | 0.355 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.81 | 1.35 | 2.44 | log | |
| Odds ratio, group 1 over group 2 | 2.88 | 1.79 | 4.64 | log | |
| Number needed to treat, for one more participant with the outcome on CT-P13 SC 120 mg than on Placebo | 3.93 | 2.82 | 6.98 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CT-P13 SC 120 mg | CT-P13 SC 120 mg | 131 | 231 | OG000 |
| Group 2 | Placebo | Placebo | 35 | 112 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
- Description
Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value.~AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7).~Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
- Time frame
- Week 54
- Population
- All-randomized population
Source ClinicalTrials.gov
Trial
- Title
- CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
- NCT number
- NCT03945019
- Phases
- PHASE3
- Conditions
- Crohn's Disease
- Interventions
- CT-P13 SC (Infliximab), Placebo SC
- Lead sponsor
- Celltrion
- Results first posted
- 2023-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03945019?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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