A Phase I Study to Evaluate Pharmacokinetics, Efficacy an... | NCT02883452 | Trialant
NCT02883452
Sponsor
Celltrion
Status
Completed
Last Update Posted
Jun 9, 2020Actual
Enrollment
181Actual
Phase
Phase 1
Conditions
Crohn's Disease
Ulcerative Colitis (Part 2 Only)
Interventions
CT-P13
CT-P13
CT-P13
CT-P13
CT-P13
CT-P13
Countries
South Korea
Protocol Section
Identification Module
NCT ID
NCT02883452
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CT-P13 1.6 (SC)
Secondary IDs
ID
Type
Description
Link
2016-002124-89
EudraCT Number
Brief Title
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
Official Title
An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis
Acronym
Not provided
Organization
CelltrionINDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 29, 2016Actual
Primary Completion Date
Feb 4, 2019Actual
Completion Date
Oct 2, 2019Actual
First Submitted Date
Aug 25, 2016
First Submission Date that Met QC Criteria
Aug 25, 2016
First Posted Date
Aug 30, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 20, 2020
Results First Submitted that Met QC Criteria
May 26, 2020
Results First Posted Date
Jun 9, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 26, 2020
Last Update Posted Date
Jun 9, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelltrionINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).
Detailed Description
A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD and active UC.
Conditions Module
Conditions
Crohn's Disease
Ulcerative Colitis (Part 2 Only)
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
181Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: CT-P13 IV 5 mg/kg
Active Comparator
CT-P13 IV (Infliximab), 5 mg/kg by IV infusion every 8 weeks (Part 1)
Biological: CT-P13
Cohort 2: CT-P13 SC 120 mg
Experimental
CT-P13 SC (Infliximab), 120 mg by SC injection every 2 weeks (Part 1)
Biological: CT-P13
Cohort 3: CT-P13 SC 180 mg
Experimental
CT-P13 SC (Infliximab), 180 mg by SC injection every 2 weeks (Part 1)
Biological: CT-P13
Cohort 4: CT-P13 SC 240 mg
Experimental
CT-P13 SC (Infliximab), 240 mg by SC injection every 2 weeks (Part 1)
Biological: CT-P13
Arm 1: CT-P13 SC 120/240 mg
Experimental
CT-P13 SC (Infliximab), either 120 mg or 240 mg every 2 weeks by SC injection (Part 2)
Biological: CT-P13
Arm 2: CT-P13 IV 5 mg/kg
Active Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CT-P13
Biological
CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)
Cohort 1: CT-P13 IV 5 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.
Week 22, 24, 26 and 28
Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)
For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22).
Week 22
Secondary Outcomes
Measure
Description
Time Frame
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of CDAI score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. 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 multiplied by the relevant weight factor; number of liquid or very soft stools (x2), abdominal pain (x5), general well-being (x7), CD complications (x20), taking lomotil/opiates for diarrhea (x30), abdominal mass (x10), deviation of hematocrit (x6), and percentage deviation from standard weight (x1). Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient has active Crohn's disease with a score on the Crohn's disease activity index between 220 and 450 points.
Patient has active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only).
Exclusion Criteria:
Patient who has previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFα) inhibitor for the treatment of other disease
Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product
Patient who has a current or past history of infection with HIV, hepatitis B, or hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled)
Patient who has acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug
Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent tuberculosis (TB) at Screening. For Part 2, if IGRA result is indeterminate at Screening, 1 retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.
Schreiber S, D'Haens G, Cummings F, Irving PM, Ye BD, Ben-Horin S, Kim DH, Jeong AL, Reinisch W. Switching from intravenous to subcutaneous infliximab maintenance therapy in inflammatory bowel disease: Post hoc longitudinal analysis of a randomized trial. Dig Liver Dis. 2024 Jul;56(7):1204-1212. doi: 10.1016/j.dld.2023.12.013. Epub 2024 Feb 15.
For Part 1, a total of 55 CD patients were screened, 45 patients were enrolled (10 screening failures) and 44 patients were randomized. For Part 2, a total of 195 CD and UC patients were screened, 136 patients were enrolled (59 screening failures) and 131 patients were randomized.
Recruitment Details
For Part 1, participants were screened from 21 study centers in 9 countries and were enrolled from 20 study centers in 9 countries. For Part 2, participants were screened from 62 study centers in 16 countries and were enrolled from 50 study centers in 15 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
FG001
Cohort 2: CT-P13 SC 120 mg (Part 1)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 9, 2018
Feb 3, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
CT-P13 IV (Infliximab), 5 mg/kg by IV infusion every 8 weeks up to Week 22. CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC (Infliximab) treatment, and further doses with CT-P13 SC were given up to Week 54. (Part 2)
Biological: CT-P13
Infliximab
CT-P13
Biological
CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1)
Cohort 2: CT-P13 SC 120 mg
Infliximab
CT-P13
Biological
CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1)
Cohort 3: CT-P13 SC 180 mg
Infliximab
CT-P13
Biological
CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1)
Cohort 4: CT-P13 SC 240 mg
Infliximab
CT-P13
Biological
CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2)
Arm 1: CT-P13 SC 120/240 mg
Infliximab
CT-P13
Biological
CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2)
Arm 2: CT-P13 IV 5 mg/kg
Infliximab
up to Week 54
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to CDAI-100 criteria up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Responder according to CDAI-100 criteria was defined as a decrease in CDAI score of 100 points or more from the baseline value.
up to Week 54
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. The partial Mayo scores range from 0-9 with higher scores indicating increased severity of disease. The index is sum of the 3 subscores, each which range from 0 to 3; stool frequency, rectal bleeding and physician's global assessment. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
up to Week 54
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to the partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Responder according to partial Mayo score was defined as a decrease from baseline in partial Mayo score of at least 2 points, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
up to Week 54
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
For evaluation of pharmacokinetics (PK), the secondary endpoint was defined as the analysis of trough concentration of infliximab up to Week 54. The samples were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. During PK monitoring visit (Weeks 22-30), samples were collected every 2 weeks according steady state PK sampling time point. All enrolled patient received CT-P13 IV infusions at Weeks 0 and 2. Patients in SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22. Then, CT-P13 IV was switched to CT-P13 SC at Week 30, and further doses with CT-P13 SC were given up to Week 54. No PK results were obtained at Weeks 6 and 14 for SC group and Weeks 12, 20, 24, 26 and 28 for IV group due to 2 weeks and 8 weeks dosing interval, respectively. All patients in PK population were analyzed according to the treatment they received.
up to Week 54
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
For evaluation of pharmacodynamic (PD), the secondary endpoint was defined as concentration of Fecal Calprotectin (FC) between 2 treatment groups up to Week 54. The fecal samples for FC were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. All enrolled patients received CT-P13 IV infusions at Weeks 0 and 2. Then, patients in CT-P13 SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in the CT-P13 IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22 (Weeks 14 and 22). And then, CT-P13 IV was switched to CT-P13 SC based on body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54. All patients in the PD population were analyzed according to the treatment they received.
up to Week 54
Derived
D'Haens G, Reinisch W, Schreiber S, Cummings F, Irving PM, Ye BD, Kim DH, Yoon S, Ben-Horin S. Subcutaneous Infliximab Monotherapy Versus Combination Therapy with Immunosuppressants in Inflammatory Bowel Disease: A Post Hoc Analysis of a Randomised Clinical Trial. Clin Drug Investig. 2023 Apr;43(4):277-288. doi: 10.1007/s40261-023-01252-z. Epub 2023 Apr 1.
Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5.
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
FG002
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
FG003
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
FG004
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
FG005
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
FG00013 subjectsThis cohort is only for Part 1.
FG00111 subjectsThis cohort is only for Part 1.
FG00212 subjectsThis cohort is only for Part 1.
FG0038 subjectsThis cohort is only for Part 1.
FG00466 subjectsThis arm is for Part 2. All of the patients in Part 2 were screened only for Part 2.
FG00565 subjectsThis arm is for Part 2. All of the patients in Part 2 were screened only for Part 2.
COMPLETED
FG0008 subjects
FG0019 subjects
FG0027 subjects
FG0036 subjects
FG00455 subjects
FG00550 subjects
NOT COMPLETED
FG0005 subjects
FG0012 subjects
FG0025 subjects
FG0032 subjects
FG00411 subjects
FG00515 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0042 subjects
FG0055 subjects
Disease progression
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All-randomized population: all randomized population consisted of all randomly assigned patients at Week 6, regardless of whether or not any study drug (CT-P13 IV, CT-P13 SC) dosing was completed.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
BG001
Cohort 2: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
BG002
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
BG003
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
BG004
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
BG005
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00013
BG00111
BG00212
BG0038
BG00466
BG00565
BG006175
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00034.0(21 to 62)
BG00133.0(22 to 67)
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian/Oriental
BG0002
BG0012
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Bosnia and Herzegovina
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.
The PK population consisted of the all-randomized population who received at least one full dose of study drug at Week 6 or thereafter and who had at least one PK concentration result after Week 6 treatment. Among them, patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) were included for primary PK analysis.
Posted
Mean
Standard Deviation
hr*ng/mL
Week 22, 24, 26 and 28
ID
Title
Description
OG000
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
OG001
Cohort 2: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
OG002
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
OG003
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
Units
Counts
Participants
OG00011
OG0019
OG00211
OG003
Title
Denominators
Categories
Week 22
ParticipantsOG00011
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG003
Primary
Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)
For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22).
The PK Population consisted of all-randomized population who received at least one full dose of study drug at Week 6 or thereafter, and who had at least one PK result after Week 6 treatment. The primary PK endpoint was analyzed in patients who received all doses (full) of study drug up to Week 22 (prior to Week 22) in the PK population.
Posted
Geometric Least Squares Mean
90% Confidence Interval
μg/mL
Week 22
ID
Title
Description
OG000
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
OG001
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
Secondary
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of CDAI score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. 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 multiplied by the relevant weight factor; number of liquid or very soft stools (x2), abdominal pain (x5), general well-being (x7), CD complications (x20), taking lomotil/opiates for diarrhea (x30), abdominal mass (x10), deviation of hematocrit (x6), and percentage deviation from standard weight (x1). Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
Posted
Mean
Standard Deviation
scores on a scale
up to Week 54
ID
Title
Description
OG000
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
Secondary
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to CDAI-100 criteria up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Responder according to CDAI-100 criteria was defined as a decrease in CDAI score of 100 points or more from the baseline value.
The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
up to Week 54
ID
Title
Description
OG000
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
OG001
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Secondary
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. The partial Mayo scores range from 0-9 with higher scores indicating increased severity of disease. The index is sum of the 3 subscores, each which range from 0 to 3; stool frequency, rectal bleeding and physician's global assessment. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
Posted
Mean
Standard Deviation
scores on a scale
up to Week 54
ID
Title
Description
OG000
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
OG001
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Secondary
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to the partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Responder according to partial Mayo score was defined as a decrease from baseline in partial Mayo score of at least 2 points, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
Posted
Count of Participants
Participants
up to Week 54
ID
Title
Description
OG000
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
OG001
Secondary
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
For evaluation of pharmacokinetics (PK), the secondary endpoint was defined as the analysis of trough concentration of infliximab up to Week 54. The samples were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. During PK monitoring visit (Weeks 22-30), samples were collected every 2 weeks according steady state PK sampling time point. All enrolled patient received CT-P13 IV infusions at Weeks 0 and 2. Patients in SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22. Then, CT-P13 IV was switched to CT-P13 SC at Week 30, and further doses with CT-P13 SC were given up to Week 54. No PK results were obtained at Weeks 6 and 14 for SC group and Weeks 12, 20, 24, 26 and 28 for IV group due to 2 weeks and 8 weeks dosing interval, respectively. All patients in PK population were analyzed according to the treatment they received.
The PK population consisted of the all-randomized population who received at least one full dose of study drug at Week 6 or thereafter and who had at least one PK concentration result after Week 6 treatment.
Posted
Mean
Standard Deviation
μg/mL
up to Week 54
ID
Title
Description
OG000
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
Secondary
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
For evaluation of pharmacodynamic (PD), the secondary endpoint was defined as concentration of Fecal Calprotectin (FC) between 2 treatment groups up to Week 54. The fecal samples for FC were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. All enrolled patients received CT-P13 IV infusions at Weeks 0 and 2. Then, patients in CT-P13 SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in the CT-P13 IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22 (Weeks 14 and 22). And then, CT-P13 IV was switched to CT-P13 SC based on body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54. All patients in the PD population were analyzed according to the treatment they received.
PD population - The PD population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC, CT-P13 IV) at Week 6 or thereafter, and who had at least 1 PD result after Week 6 treatment.
Posted
Mean
Standard Deviation
μg/g
up to Week 54
ID
Title
Description
OG000
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
OG001
Time Frame
Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
Description
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
1
13
4
13
10
13
EG001
Cohort 2: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
0
11
2
11
9
11
EG002
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
1
12
1
12
8
12
EG003
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
0
8
3
8
7
8
EG004
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
0
66
6
66
42
66
EG005
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV were switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
0
65
8
65
36
65
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG0030 affected8 at risk
EG0041 affected66 at risk
EG0050 affected65 at risk
Colitis ulcerative
Gastrointestinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Anal abscess
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Appendicitis
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Disseminated tuberculosis
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Pneumonia legionella
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Viral infection
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Crohn's disease
Gastrointestinal disorders
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected11 at risk
EG0020 affected12 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Sudden cardiac death
General disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Sudden death
General disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0021 affected12 at risk
EG003
Abscess intestinal
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Transient ischaemic attack
Nervous system disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG0030 affected8 at risk
EG0044 affected66 at risk
EG0052 affected65 at risk
Neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0022 affected12 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Localized Injection site reaction
General disorders
Systematic Assessment
General disorders and administration site conditions; preferred term reported as injection site reaction
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0023 affected12 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Oral herpes
Infections and infestations
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0021 affected12 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0002 affected13 at risk
EG0010 affected11 at risk
EG0021 affected12 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Arrhythmia
Cardiac disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Bundle branch block right
Cardiac disorders
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Palpitations
Cardiac disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Sinus bradycardia
Cardiac disorders
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0001 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Crohn's disease
Gastrointestinal disorders
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected11 at risk
EG0020 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Toothache
Gastrointestinal disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Herpes zoster
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Latent tuberculosis
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0022 affected12 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Sinobronchitis
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0012 affected11 at risk
EG0020 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0001 affected13 at risk
EG0012 affected11 at risk
EG0020 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Varicella
Infections and infestations
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected11 at risk
EG0020 affected12 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0004 affected13 at risk
EG0012 affected11 at risk
EG0020 affected12 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected13 at risk
EG0010 affected11 at risk
EG0021 affected12 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
Systematic Assessment
Infusion related reaction occurred between start of administration and 24 hours from the end of IV infusion
EG0001 affected13 at risk
EG0010 affected11 at risk
EG0020 affected12 at risk
EG003
Delayed hypersensitivity
Injury, poisoning and procedural complications
Systematic Assessment
Delayed hypersensitivity occurred after 24 hours from the study drug administration
Primary PK analysis was analyzed using an ANCOVA with treatment as fixed effect and current use of treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) (used or not used), disease (CD or UC), clinical response at Week 6 (responder or non-responder by Clinical Disease Activity Index [CDAI]-70 for CD or partial Mayo score for UC), body weight at Week 6 (<80 kg or ≥80 kg) fitted as covariates.
Ratio of Geometric LS means
1154.17
2-Sided
90
786.37
1694.00
The geometric lease square (LS) means, ratio of geometric LS means (CT-P13 SC 120/240 mg to CT-P13 IV 5 mg/kg), and 2-sided 90% CI were obtained from the ANCOVA model.
Non-Inferiority
The non-inferiority of CT-P13 SC to CT-P13 IV was to be concluded if the lower bound of two-sided 90% CI for the ratio of geometric least square means was higher than 80%.
OG001
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
Units
Counts
Participants
OG00028
OG00125
Title
Denominators
Categories
Baseline
ParticipantsOG00028
ParticipantsOG00125
Title
Measurements
OG000296.38± 59.212
OG001294.75± 59.899
Week 2
ParticipantsOG00028
ParticipantsOG00124
Title
Measurements
OG000194.89± 74.943
OG001
Week 6
ParticipantsOG00028
ParticipantsOG00125
Title
Measurements
OG000164.99± 96.360
OG001
Week 14
ParticipantsOG00027
ParticipantsOG00125
Title
Measurements
OG000136.29± 85.918
OG001
Week 22
ParticipantsOG00024
ParticipantsOG00121
Title
Measurements
OG000106.55± 80.461
OG001
Week 30
ParticipantsOG00024
ParticipantsOG00120
Title
Measurements
OG000103.81± 88.435
OG001
Week 54
ParticipantsOG00022
ParticipantsOG00118
Title
Measurements
OG00092.03± 77.622
OG001
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
Units
Counts
Participants
OG00028
OG00125
Title
Denominators
Categories
Week 2
Title
Measurements
OG00013
OG0019
Week 6
Title
Measurements
OG00016
OG00117
Week 14
Title
Measurements
OG00019
OG00118
Week 22
Title
Measurements
OG00021
OG00120
Week 30
Title
Measurements
OG00019
OG00116
Week 54
Title
Measurements
OG00018
OG00116
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
Units
Counts
Participants
OG00038
OG00139
Title
Denominators
Categories
Baseline
ParticipantsOG00038
ParticipantsOG00139
Title
Measurements
OG0005.4± 1.31
OG0015.9± 1.21
Week 2
ParticipantsOG00038
ParticipantsOG00139
Title
Measurements
OG0003.3± 2.18
OG001
Week 6
ParticipantsOG00038
ParticipantsOG00139
Title
Measurements
OG0002.6± 2.13
OG001
Week 14
ParticipantsOG00036
ParticipantsOG00139
Title
Measurements
OG0001.7± 1.62
OG001
Week 22
ParticipantsOG00035
ParticipantsOG00136
Title
Measurements
OG0001.3± 1.63
OG001
Week 30
ParticipantsOG00035
ParticipantsOG00136
Title
Measurements
OG0001.2± 1.59
OG001
Week 54
ParticipantsOG00032
ParticipantsOG00132
Title
Measurements
OG0000.9± 1.31
OG001
Arm 1: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
Units
Counts
Participants
OG00038
OG00139
Title
Denominators
Categories
Week 2
Title
Measurements
OG00020
OG00125
Week 6
Title
Measurements
OG00028
OG00131
Week 14
Title
Measurements
OG00030
OG00133
Week 22
Title
Measurements
OG00032
OG00130
Week 30
Title
Measurements
OG00033
OG00129
Week 54
Title
Measurements
OG00031
OG00128
OG001
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
Units
Counts
Participants
OG00063
OG00164
Title
Denominators
Categories
Week 0
ParticipantsOG00063
ParticipantsOG00164
Title
Measurements
OG00023.5432± 8.43542
OG00121.8589± 7.36954
Week 2
ParticipantsOG00063
ParticipantsOG00164
Title
Measurements
OG00015.4736± 9.15888
OG001
Week 6
ParticipantsOG0000
ParticipantsOG00164
Title
Measurements
OG0013.7865± 2.99669
Week 12
ParticipantsOG00063
ParticipantsOG0010
Title
Measurements
OG00020.9700± 9.21851
Week 14
ParticipantsOG0000
ParticipantsOG00157
Title
Measurements
OG0012.9317± 2.60859
Week 20
ParticipantsOG00059
ParticipantsOG0010
Title
Measurements
OG00021.4500± 9.86306
Week 22
ParticipantsOG00028
ParticipantsOG00148
Title
Measurements
OG00019.6786± 8.94416
OG001
Week 24
ParticipantsOG00029
ParticipantsOG0010
Title
Measurements
OG00020.1528± 10.53981
Week 26
ParticipantsOG00030
ParticipantsOG0010
Title
Measurements
OG00022.3410± 9.81672
Week 28
ParticipantsOG00049
ParticipantsOG0010
Title
Measurements
OG00021.0978± 8.98618
Week 36
ParticipantsOG00059
ParticipantsOG00153
Title
Measurements
OG00022.1927± 9.97943
OG001
Week 44
ParticipantsOG00056
ParticipantsOG00150
Title
Measurements
OG00022.5780± 11.72637
OG001
Week 52
ParticipantsOG00053
ParticipantsOG00149
Title
Measurements
OG00022.7928± 13.17095
OG001
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients < 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.