Crohn's Disease
Conditions
Brief summary
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
Interventions
Sponsors
Pfizer
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points
Exclusion criteria
* Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other disease. * Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 | at Week 6 | A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 | Week 54 | A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value. |
| The Number and Percentage of Patients Achieving Clinical Remission at Week 6 | Week 6 | Clinical remission was defined as an absolute CDAI score of less than 150 points. |
| The Number and Percentage of Patients Achieving Clinical Remission at Week 30 | Week 30 | Clinical remission was defined as an absolute CDAI score of less than 150 points. |
| The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30 | Week 30 | A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value. |
| The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Up to Week 30 | SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome. |
| The Short Inflammatory Bowel Disease Questionnaire | Baseline and Week 54 | SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome. |
| The Number and Percentage of Patients Achieving Clinical Remission at Week 54 | Week 54 | Clinical remission was defined as an absolute CDAI score of less than 150 points. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT-P13 - CT-P13 CT-P13 followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | 56 |
| CT-P13 - Remicade CT-P13 followed by Remicade from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | 55 |
| Remicade - Remicade Remicade followed by Remicade from Week 30
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | 54 |
| Remicade - CT-P13 Remicade followed by CT-P13 from Week 30
CT-P13: CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade: Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | 55 |
| Total | 220 |
Baseline characteristics
| Characteristic | CT-P13 - CT-P13 | CT-P13 - Remicade | Remicade - Remicade | Remicade - CT-P13 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 53 Participants | 52 Participants | 55 Participants | 214 Participants |
| Age, Continuous | 39 years | 31 years | 31 years | 35 years | 33 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 14 Participants | 13 Participants | 16 Participants | 54 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 41 Participants | 40 Participants | 39 Participants | 165 Participants |
| Region of Enrollment Belgium | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Brazil | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Region of Enrollment Denmark | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment France | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Region of Enrollment Germany | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Hungary | 1 Participants | 5 Participants | 4 Participants | 1 Participants | 11 Participants |
| Region of Enrollment Israel | 8 Participants | 6 Participants | 8 Participants | 4 Participants | 26 Participants |
| Region of Enrollment Italy | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 12 Participants |
| Region of Enrollment Mexico | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Region of Enrollment Netherlands | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Region of Enrollment Poland | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 5 Participants |
| Region of Enrollment Romania | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 8 Participants |
| Region of Enrollment Russia | 15 Participants | 15 Participants | 8 Participants | 12 Participants | 50 Participants |
| Region of Enrollment South Korea | 11 Participants | 14 Participants | 13 Participants | 16 Participants | 54 Participants |
| Region of Enrollment Ukraine | 7 Participants | 6 Participants | 10 Participants | 9 Participants | 32 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 27 Participants | 21 Participants | 28 Participants | 21 Participants | 97 Participants |
| Sex: Female, Male Male | 29 Participants | 34 Participants | 26 Participants | 34 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 55 | 0 / 54 | 0 / 55 |
| other Total, other adverse events | 37 / 56 | 36 / 55 | 36 / 54 | 40 / 55 |
| serious Total, serious adverse events | 4 / 56 | 4 / 55 | 4 / 54 | 7 / 55 |
Outcome results
Primary
The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.
Time frame: at Week 6
Population: CT-P13 treatment group including CT-P13 - CT-P13 and CT-P13 - Remicade treatment groups.~Remicade treatment group including Remicade - Remicade and Remicade - CT-P13 treatment groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 | The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 | 77 Participants |
| Remicade | The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 | 81 Participants |
Secondary
The Number and Percentage of Patients Achieving Clinical Remission at Week 30
Clinical remission was defined as an absolute CDAI score of less than 150 points.
Time frame: Week 30
Population: CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 | The Number and Percentage of Patients Achieving Clinical Remission at Week 30 | 61 Participants |
| Remicade | The Number and Percentage of Patients Achieving Clinical Remission at Week 30 | 62 Participants |
Secondary
The Number and Percentage of Patients Achieving Clinical Remission at Week 54
Clinical remission was defined as an absolute CDAI score of less than 150 points.
Time frame: Week 54
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 | The Number and Percentage of Patients Achieving Clinical Remission at Week 54 | 35 Participants |
| Remicade | The Number and Percentage of Patients Achieving Clinical Remission at Week 54 | 32 Participants |
| Remicade - Remicade | The Number and Percentage of Patients Achieving Clinical Remission at Week 54 | 29 Participants |
| Remicade - CT-P13 | The Number and Percentage of Patients Achieving Clinical Remission at Week 54 | 33 Participants |
Secondary
The Number and Percentage of Patients Achieving Clinical Remission at Week 6
Clinical remission was defined as an absolute CDAI score of less than 150 points.
Time frame: Week 6
Population: CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 | The Number and Percentage of Patients Achieving Clinical Remission at Week 6 | 47 Participants |
| Remicade | The Number and Percentage of Patients Achieving Clinical Remission at Week 6 | 49 Participants |
Secondary
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.
Time frame: Week 30
Population: CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 | The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30 | 85 Participants |
| Remicade | The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30 | 82 Participants |
Secondary
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.
Time frame: Week 54
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P13 | The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 | 44 Participants |
| Remicade | The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 | 39 Participants |
| Remicade - Remicade | The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 | 38 Participants |
| Remicade - CT-P13 | The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 | 42 Participants |
Secondary
The Short Inflammatory Bowel Disease Questionnaire
SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome.
Time frame: Baseline and Week 54
Population: Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P13 | The Short Inflammatory Bowel Disease Questionnaire | Baseline | 34.7 scores on a scale | Standard Deviation 10.61 |
| CT-P13 | The Short Inflammatory Bowel Disease Questionnaire | Week 54 | 54.4 scores on a scale | Standard Deviation 10.28 |
| Remicade | The Short Inflammatory Bowel Disease Questionnaire | Week 54 | 54.1 scores on a scale | Standard Deviation 11.07 |
| Remicade | The Short Inflammatory Bowel Disease Questionnaire | Baseline | 33.8 scores on a scale | Standard Deviation 11.31 |
| Remicade - Remicade | The Short Inflammatory Bowel Disease Questionnaire | Baseline | 33.3 scores on a scale | Standard Deviation 9.77 |
| Remicade - Remicade | The Short Inflammatory Bowel Disease Questionnaire | Week 54 | 52.6 scores on a scale | Standard Deviation 11.35 |
| Remicade - CT-P13 | The Short Inflammatory Bowel Disease Questionnaire | Baseline | 34.5 scores on a scale | Standard Deviation 8.81 |
| Remicade - CT-P13 | The Short Inflammatory Bowel Disease Questionnaire | Week 54 | 51.2 scores on a scale | Standard Deviation 11.26 |
Secondary
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome.
Time frame: Up to Week 30
Population: Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit.~CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P13 | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Baseline | 34.3 scores on a scale | Standard Deviation 10.92 |
| CT-P13 | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Week 6 | 46.4 scores on a scale | Standard Deviation 10.86 |
| CT-P13 | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Week 30 | 51.1 scores on a scale | Standard Deviation 11.96 |
| Remicade | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Baseline | 33.9 scores on a scale | Standard Deviation 9.27 |
| Remicade | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Week 30 | 52.5 scores on a scale | Standard Deviation 10.68 |
| Remicade | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Week 6 | 45.8 scores on a scale | Standard Deviation 12.54 |