A Phase 3 interventional study of CT-P13 SC (Infliximab) and Placebo SC in Crohn's Disease, sponsored by Celltrion. Completed at 29 sites in 26 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Celltrion · Phase 3, Interventional, and Treatment
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 396 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: CT-P13 SC (Infliximab)
Other: Placebo SC
Subcutaneous injection of CT-P13 SC
Subcutaneous injection of Placebo SC
Percentage of Patients Achieving Clinical Remission (Based on CDAI) at 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.
Time frame: Week 54
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at 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.
Time frame: Week 54
Percentage of Patients Achieving CDAI-100 Response at 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.
Time frame: Week 54
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at 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.
Time frame: Week 54
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at 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.
Time frame: Week 54
| Milestone | CT-P13 IV 5mg/kg | CT-P13 SC 120 mg | Placebo |
|---|---|---|---|
| Started | 396 | 0 | 0 |
| Completed | 343 | 0 | 0 |
| Not completed | 53 | 0 | 0 |
| Milestone | CT-P13 IV 5mg/kg | CT-P13 SC 120 mg | Placebo |
|---|---|---|---|
| Started | 0 | 231 | 112 |
| Completed | 0 | 196 | 87 |
| Not completed | 0 | 35 | 25 |
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.
| Participants | CT-P13 SC 120 mg | Placebo |
|---|---|---|
| Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | 144 | 36 |
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.
| Participants | CT-P13 SC 120 mg | Placebo |
|---|---|---|
| Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | 118 | 20 |
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.
| Participants | CT-P13 SC 120 mg | Placebo |
|---|---|---|
| Percentage of Patients Achieving CDAI-100 Response at Week 54 | 152 | 43 |
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.
| Participants | CT-P13 SC 120 mg | Placebo |
|---|---|---|
| Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | 131 | 35 |
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.
| Participants | CT-P13 SC 120 mg | Placebo SC |
|---|---|---|
| Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | 80 | 12 |
Collected over For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CT-P13 IV 5 mg/kg | 0/396 (0%) | 12/396 (3%) | 51/396 (12.9%) |
| CT-P13 SC 120 mg (Including 240 mg) | 1/238 (0.4%) | 16/238 (6.7%) | 75/238 (31.5%) |
| CT-P13 SC 120 mg | 1/238 (0.4%) | 15/238 (6.3%) | 70/238 (29.4%) |
| CT-P13 SC 120 mg to 240 mg | 0/45 (0%) | 1/45 (2.2%) | 9/45 (20%) |
| Placebo | 0/105 (0%) | 8/105 (7.6%) | 30/105 (28.6%) |
| Event | CT-P13 IV 5 mg/kg | CT-P13 SC 120 mg (Including 240 mg) | CT-P13 SC 120 mg | CT-P13 SC 120 mg to 240 mg | Placebo |
|---|---|---|---|---|---|
| Haemorrhoids (study drug unrelated)Gastrointestinal disorders | 0/396 | 1/238 | 0/238 | 1/45 | 0/105 |
| Crohn's disease (study drug unrelated)Gastrointestinal disorders | 6/396 | 3/238 | 3/238 | 0/45 | 1/105 |
| Anaemia (study drug unrelated)Blood and lymphatic system disorders | 0/396 | 0/238 | 0/238 | 0/45 | 1/105 |
| Intestinal perforation (study drug unrelated)Gastrointestinal disorders | 0/396 | 0/238 | 0/238 | 0/45 | 1/105 |
| Peritonitis (study drug unrelated)Infections and infestations | 2/396 | 0/238 | 0/238 | 0/45 | 1/105 |
| Humerus fracture (study drug unrelated)Injury, poisoning and procedural complications | 0/396 | 0/238 | 0/238 | 0/45 | 1/105 |
| Blood creatine phosphokinase increased (study drug related)Investigations | 0/396 | 0/238 | 0/238 | 0/45 | 1/105 |
| Colon cancer stage III (study drug unrelated)Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/396 | 0/238 | 0/238 | 0/45 | 1/105 |
| Psychotic disorder (study drug unrelated)Psychiatric disorders | 0/396 | 0/238 | 0/238 | 0/45 | 1/105 |
| Infusion related reaction (study drug related)Injury, poisoning and procedural complications | 2/396 | 0/238 | 0/238 | 0/45 | 0/105 |
| Event | CT-P13 IV 5 mg/kg | CT-P13 SC 120 mg (Including 240 mg) | CT-P13 SC 120 mg | CT-P13 SC 120 mg to 240 mg | Placebo |
|---|---|---|---|---|---|
| Crohn's diseaseGastrointestinal disorders | 10/396 | 12/238 | 11/238 | 1/45 | 17/105 |
| COVID-19Infections and infestations | 10/396 | 27/238 | 22/238 | 5/45 | 5/105 |
| HeadacheNervous system disorders | 18/396 | 18/238 | 18/238 | 0/45 | 5/105 |
| AnaemiaBlood and lymphatic system disorders | 16/396 | 13/238 | 11/238 | 3/45 | 5/105 |
| Injection site reactionGeneral disorders | 2/396 | 14/238 | 11/238 | 3/45 | 1/105 |
All-randomized population
| Age, Continuous(years) | CT-P13 SC 120 mg | Placebo | Total |
|---|---|---|---|
| Mean | 36.0 ± 12.53 | 32.3 ± 11.53 | 34.8 ± 12.32 |
| Sex: Female, Male(Participants) | CT-P13 SC 120 mg | Placebo | Total |
|---|---|---|---|
| Female | 97 | 43 | 140 |
| Male | 134 | 69 | 203 |
| Race/Ethnicity, Customized(Participants) | CT-P13 SC 120 mg | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 8 | 5 | 13 |
| Asian | 9 | 4 | 13 |
| Black or African American | 1 | 0 | 1 |
| White | 211 | 101 | 312 |
| Other | 2 | 2 | 4 |
| Region of Enrollment(participants) | CT-P13 SC 120 mg | Placebo | Total |
|---|---|---|---|
| Belarus | 3 | 3 | 6 |
| Bulgaria | 6 | 0 | 6 |
| Croatia | 12 | 2 | 14 |
| Czechia | 7 | 6 | 13 |
| France | 2 | 0 | 2 |
| Germany | 2 | 1 | 3 |
| Greece | 2 | 0 | 2 |
| Hungary | 6 | 6 | 12 |
| India | 4 | 2 | 6 |
| Israel | 13 | 4 | 17 |
| Italy | 9 | 5 | 14 |
| Japan | 3 | 2 | 5 |
| Latvia | 3 | 0 | 3 |
| Mexico | 8 | 5 | 13 |
| Moldova | 1 | 0 | 1 |
| Peru | 2 | 2 | 4 |
| Poland | 52 | 33 | 85 |
| Romania | 2 | 0 | 2 |
| Russia | 49 | 15 | 64 |
| Serbia | 6 | 7 | 13 |
| Slovakia | 1 | 4 | 5 |
| South Africa | 1 | 2 | 3 |
| Spain | 3 | 0 | 3 |
| Turkey | 1 | 0 | 1 |
| Ukraine | 29 | 13 | 42 |
| United States | 4 | 0 | 4 |
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