Trial · NCT03945019
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
NCT03945019, Phase 3, Completed, Celltrion; results first posted 2023-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD). Trials, record NCT03945019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03945019
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
- NCT number
- NCT03945019
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 396 participants, actual
- Lead sponsor
- Celltrion
- Conditions
- Crohn's Disease
- Interventions
- CT-P13 SC (Infliximab), Placebo SC
- First posted
- 2019-05-10
- Last updated
- 2023-10-23
- Other registries' IDs
- eudract:2019-001087-30
- Results first posted
- 2023-10-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | Week 54 | Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of \<150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. |
| Primary | Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | Week 54 | Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level. |
| Secondary | Percentage of Patients Achieving CDAI-100 Response at Week 54 | Week 54 | Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. |
| Secondary | Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | Week 54 | 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. |
| Secondary | Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | Week 54 | Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of \>1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | Week 54 | All-randomized population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | Week 54 | All-randomized population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Achieving CDAI-100 Response at Week 54 | Week 54 | All-randomized population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | Week 54 | All-randomized population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | Week 54 | All-randomized population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | CT-P13 SC 120 mg | 144 | Participants | ||
| Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | Placebo | 36 | Participants | ||
| Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | CT-P13 SC 120 mg | 118 | Participants | ||
| Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | Placebo | 20 | Participants | ||
| Percentage of Patients Achieving CDAI-100 Response at Week 54 | CT-P13 SC 120 mg | 152 | Participants | ||
| Percentage of Patients Achieving CDAI-100 Response at Week 54 | Placebo | 43 | Participants | ||
| Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | CT-P13 SC 120 mg | 131 | Participants | ||
| Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | Placebo | 35 | Participants | ||
| Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | CT-P13 SC 120 mg | 80 | Participants | ||
| Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | Placebo SC | 12 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Phase | STARTED | CT-P13 IV 5mg/kg | 396 | |
| Induction Phase | STARTED | CT-P13 SC 120 mg | 0 | |
| Induction Phase | STARTED | Placebo | 0 | |
| Induction Phase | COMPLETED | CT-P13 IV 5mg/kg | 343 | |
| Induction Phase | COMPLETED | CT-P13 SC 120 mg | 0 | |
| Induction Phase | COMPLETED | Placebo | 0 | |
| Induction Phase | NOT COMPLETED | CT-P13 IV 5mg/kg | 53 | |
| Induction Phase | NOT COMPLETED | CT-P13 SC 120 mg | 0 | |
| Induction Phase | NOT COMPLETED | Placebo | 0 | |
| Maintenance Phase | STARTED | CT-P13 IV 5mg/kg | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events200
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | CT-P13 IV 5 mg/kg | 16 | 396 | |
| other | Anaemia | Blood and lymphatic system disorders | CT-P13 SC 120 mg (Including 240 mg) | 13 | 238 | |
| other | Anaemia | Blood and lymphatic system disorders | CT-P13 SC 120 mg | 11 | 238 | |
| other | Anaemia | Blood and lymphatic system disorders | CT-P13 SC 120 mg to 240 mg | 3 | 45 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 5 | 105 | |
| other | Crohn's disease | Gastrointestinal disorders | CT-P13 IV 5 mg/kg | 10 | 396 | |
| other | Crohn's disease | Gastrointestinal disorders | CT-P13 SC 120 mg (Including 240 mg) | 12 | 238 | |
| other | Crohn's disease | Gastrointestinal disorders | CT-P13 SC 120 mg | 11 | 238 | |
| other | Crohn's disease | Gastrointestinal disorders | CT-P13 SC 120 mg to 240 mg | 1 | 45 | |
| other | Crohn's disease | Gastrointestinal disorders | Placebo | 17 | 105 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CT-P13 IV 5 mg/kg | 0 | 396 |
| Total, all-cause mortality | CT-P13 SC 120 mg (Including 240 mg) | 1 | 238 |
| Total, all-cause mortality | CT-P13 SC 120 mg | 1 | 238 |
| Total, all-cause mortality | CT-P13 SC 120 mg to 240 mg | 0 | 45 |
| Total, all-cause mortality | Placebo | 0 | 105 |
| Total, other adverse events | CT-P13 IV 5 mg/kg | 51 | 396 |
| Total, other adverse events | CT-P13 SC 120 mg (Including 240 mg) | 75 | 238 |
| Total, other adverse events | CT-P13 SC 120 mg | 70 | 238 |
| Total, other adverse events | CT-P13 SC 120 mg to 240 mg | 9 | 45 |
| Total, other adverse events | Placebo | 30 | 105 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CT-P13 SC 120 mg vs Placebo: Percentage of Patients Achieving CDAI-100 Response at Week 54 | Trial comparisons |
| CT-P13 SC 120 mg vs Placebo: Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | Trial comparisons |
| CT-P13 SC 120 mg vs Placebo: Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | Trial comparisons |
| CT-P13 SC 120 mg vs Placebo: Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | Trial comparisons |
| CT-P13 SC 120 mg vs Placebo SC: Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03945019
GET https://conductscience.org/api/trials/v1/NCT03945019/events?page=2