Crohn's Disease
Conditions
Brief summary
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
Interventions
BIOLOGICALCT-P13 SC (Infliximab)
Subcutaneous injection of CT-P13 SC
OTHERPlacebo SC
Subcutaneous injection of Placebo SC
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient is male or female aged 18 to 75 years, inclusive. * Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points
Exclusion criteria
* Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives * Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Belarus, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Mexico, Moldova, Peru, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT-P13 SC 120 mg CT-P13 SC 120 mg | 231 |
| Placebo Placebo | 112 |
| Total | 343 |
Baseline characteristics
| Characteristic | Placebo | Total | CT-P13 SC 120 mg |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 11.53 | 34.8 years STANDARD_DEVIATION 12.32 | 36.0 years STANDARD_DEVIATION 12.53 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants | 13 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 13 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 101 Participants | 312 Participants | 211 Participants |
| Region of Enrollment Belarus | 3 participants | 6 participants | 3 participants |
| Region of Enrollment Bulgaria | 0 participants | 6 participants | 6 participants |
| Region of Enrollment Croatia | 2 participants | 14 participants | 12 participants |
| Region of Enrollment Czechia | 6 participants | 13 participants | 7 participants |
| Region of Enrollment France | 0 participants | 2 participants | 2 participants |
| Region of Enrollment Germany | 1 participants | 3 participants | 2 participants |
| Region of Enrollment Greece | 0 participants | 2 participants | 2 participants |
| Region of Enrollment Hungary | 6 participants | 12 participants | 6 participants |
| Region of Enrollment India | 2 participants | 6 participants | 4 participants |
| Region of Enrollment Israel | 4 participants | 17 participants | 13 participants |
| Region of Enrollment Italy | 5 participants | 14 participants | 9 participants |
| Region of Enrollment Japan | 2 participants | 5 participants | 3 participants |
| Region of Enrollment Latvia | 0 participants | 3 participants | 3 participants |
| Region of Enrollment Mexico | 5 participants | 13 participants | 8 participants |
| Region of Enrollment Moldova | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Peru | 2 participants | 4 participants | 2 participants |
| Region of Enrollment Poland | 33 participants | 85 participants | 52 participants |
| Region of Enrollment Romania | 0 participants | 2 participants | 2 participants |
| Region of Enrollment Russia | 15 participants | 64 participants | 49 participants |
| Region of Enrollment Serbia | 7 participants | 13 participants | 6 participants |
| Region of Enrollment Slovakia | 4 participants | 5 participants | 1 participants |
| Region of Enrollment South Africa | 2 participants | 3 participants | 1 participants |
| Region of Enrollment Spain | 0 participants | 3 participants | 3 participants |
| Region of Enrollment Turkey | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Ukraine | 13 participants | 42 participants | 29 participants |
| Region of Enrollment United States | 0 participants | 4 participants | 4 participants |
| Sex: Female, Male Female | 43 Participants | 140 Participants | 97 Participants |
| Sex: Female, Male Male | 69 Participants | 203 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 396 | 1 / 238 | 1 / 238 | 0 / 45 | 0 / 105 |
| other Total, other adverse events | 51 / 396 | 75 / 238 | 70 / 238 | 9 / 45 | 30 / 105 |
| serious Total, serious adverse events | 12 / 396 | 16 / 238 | 15 / 238 | 1 / 45 | 8 / 105 |
Outcome results
Primary
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
Population: All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | 144 Participants |
| Placebo | Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 | 36 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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
Population: All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | 118 Participants |
| Placebo | Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54 | 20 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
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
Population: All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage of Patients Achieving CDAI-100 Response at Week 54 | 152 Participants |
| Placebo | Percentage of Patients Achieving CDAI-100 Response at Week 54 | 43 Participants |
Secondary
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
Population: All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | 131 Participants |
| Placebo | Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54 | 35 Participants |
Secondary
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
Population: All-randomized population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 SC 120 mg | Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | 80 Participants |
| Placebo | Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54 | 12 Participants |