Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease

• ClinicalTrials.gov Identifier: NCT02096861
• Recruitment Status: Completed
• First Posted: March 26, 2014
• Results First Posted: April 11, 2018
• Last Update Posted: May 9, 2018
• Sponsor: Celltrion
• Collaborator: Pfizer
• Information provided by (Responsible Party): Celltrion

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Crohn's Disease
• Interventions: Biological: CT-P13; Biological: Remicade
• Enrollment: 220

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	CT-P13 - CT-P13	CT-P13 - Remicade	Remicade - Remicade	Remicade - CT-P13
Arm/Group Description	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	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	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	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
Period Title: Overall Study
Started	56 [1]	55 [2]	54 [3]	55 [4]
Drug Switching at Week 30	48	44	41	47
Completed	44	40	37	45
Not Completed	12	15	17	10
[1] CT-P13 followed by CT-P13 from Week 30; [2] CT-P13 followed by Remicade from Week 30; [3] Remicade followed by Remicade from Week 30; [4] Remicade followed by CT-P13 from Week 30

Baseline Characteristics

Arm/Group Title		CT-P13 - CT-P13	CT-P13 - Remicade	Remicade - Remicade	Remicade - CT-P13	Total
Arm/Group Description		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	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	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	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	Total of all reporting groups
Overall Number of Baseline Participants		56	55	54	55	220
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	55 participants	54 participants	55 participants	220 participants
	<=18 years	0 0.0%	1 1.8%	1 1.9%	0 0.0%	2 0.9%
	Between 18 and 65 years	54 96.4%	53 96.4%	52 96.3%	55 100.0%	214 97.3%
	>=65 years	2 3.6%	1 1.8%	1 1.9%	0 0.0%	4 1.8%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	56 participants	55 participants	54 participants	55 participants	220 participants
		39; (19 to 68)	31; (18 to 69)	31; (18 to 69)	35; (19 to 63)	33; (18 to 69)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	55 participants	54 participants	55 participants	220 participants
	Female	27 48.2%	21 38.2%	28 51.9%	21 38.2%	97 44.1%
	Male	29 51.8%	34 61.8%	26 48.1%	34 61.8%	123 55.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	55 participants	54 participants	55 participants	220 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	11 19.6%	14 25.5%	13 24.1%	16 29.1%	54 24.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	1 1.9%	0 0.0%	1 0.5%
	White	45 80.4%	41 74.5%	40 74.1%	39 70.9%	165 75.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	56 participants	55 participants	54 participants	55 participants	220 participants
Belgium		0 0.0%	0 0.0%	0 0.0%	2 3.6%	2 0.9%
Brazil		0 0.0%	1 1.8%	1 1.9%	0 0.0%	2 0.9%
Denmark		1 1.8%	0 0.0%	0 0.0%	0 0.0%	1 0.5%
France		2 3.6%	1 1.8%	1 1.9%	1 1.8%	5 2.3%
Germany		0 0.0%	0 0.0%	1 1.9%	1 1.8%	2 0.9%
Hungary		1 1.8%	5 9.1%	4 7.4%	1 1.8%	11 5.0%
Israel		8 14.3%	6 10.9%	8 14.8%	4 7.3%	26 11.8%
Italy		3 5.4%	4 7.3%	2 3.7%	3 5.5%	12 5.5%
Mexico		2 3.6%	0 0.0%	0 0.0%	2 3.6%	4 1.8%
Netherlands		2 3.6%	0 0.0%	1 1.9%	0 0.0%	3 1.4%
Poland		1 1.8%	1 1.8%	3 5.6%	0 0.0%	5 2.3%
Romania		2 3.6%	1 1.8%	2 3.7%	3 5.5%	8 3.6%
Russia		15 26.8%	15 27.3%	8 14.8%	12 21.8%	50 22.7%
South Korea		11 19.6%	14 25.5%	13 24.1%	16 29.1%	54 24.5%
Ukraine		7 12.5%	6 10.9%	10 18.5%	9 16.4%	32 14.5%
United States		1 1.8%	1 1.8%	0 0.0%	1 1.8%	3 1.4%

Outcome Measures

1. Primary Outcome

Title	The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CT-P13	Remicade
Arm/Group Description:	CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose	Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Overall Number of Participants Analyzed	111	109
Measure Type: Count of Participants; Unit of Measure: Participants
	77 69.4%	81 74.3%

2. Secondary Outcome

Title	The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	CT-P13	Remicade
Arm/Group Description:	CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose	Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Overall Number of Participants Analyzed	111	109
Measure Type: Count of Participants; Unit of Measure: Participants
	85 76.6%	82 75.2%

3. Secondary Outcome

Title	The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-P13 - CT-P13	CT-P13 - Remicade	Remicade - Remicade	Remicade - CT-P13
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	56	55	54	55
Measure Type: Count of Participants; Unit of Measure: Participants
	44 78.6%	39 70.9%	38 70.4%	42 76.4%

4. Secondary Outcome

Title	The Number and Percentage of Patients Achieving Clinical Remission at Week 6
Description	Clinical remission was defined as an absolute CDAI score of less than 150 points.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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/Group Title	CT-P13	Remicade
Arm/Group Description:	CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose	Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Overall Number of Participants Analyzed	111	109
Measure Type: Count of Participants; Unit of Measure: Participants
	47 42.3%	49 45.0%

5. Secondary Outcome

Title	The Number and Percentage of Patients Achieving Clinical Remission at Week 30
Description	Clinical remission was defined as an absolute CDAI score of less than 150 points.
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

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/Group Title	CT-P13	Remicade
Arm/Group Description:	CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose	Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Overall Number of Participants Analyzed	111	109
Measure Type: Count of Participants; Unit of Measure: Participants
	61 55.0%	62 56.9%

6. Secondary Outcome

Title	The Number and Percentage of Patients Achieving Clinical Remission at Week 54
Description	Clinical remission was defined as an absolute CDAI score of less than 150 points.
Time Frame	Week 54

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-P13 - CT-P13	CT-P13 - Remicade	Remicade - Remicade	Remicade - CT-P13
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	56	55	54	55
Measure Type: Count of Participants; Unit of Measure: Participants
	35 62.5%	32 58.2%	29 53.7%	33 60.0%

7. Secondary Outcome

Title	The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title		CT-P13	Remicade
Arm/Group Description:		CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose	Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Overall Number of Participants Analyzed		111	109
Mean (Standard Deviation); Unit of Measure: scores on a scale
Baseline	Number Analyzed	111 participants	109 participants
		34.3 (10.92)	33.9 (9.27)
Week 6	Number Analyzed	107 participants	107 participants
		46.4 (10.86)	45.8 (12.54)
Week 30	Number Analyzed	92 participants	88 participants
		51.1 (11.96)	52.5 (10.68)

8. Secondary Outcome

Title	The Short Inflammatory Bowel Disease Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit.

Arm/Group Title		CT-P13 - CT-P13	CT-P13 - Remicade	Remicade - Remicade	Remicade - CT-P13
Arm/Group Description:		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	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	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	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
Overall Number of Participants Analyzed		56	55	54	55
Mean (Standard Deviation); Unit of Measure: scores on a scale
Baseline	Number Analyzed	56 participants	55 participants	54 participants	55 participants
		34.7 (10.61)	33.8 (11.31)	33.3 (9.77)	34.5 (8.81)
Week 54	Number Analyzed	45 participants	41 participants	37 participants	47 participants
		54.4 (10.28)	54.1 (11.07)	52.6 (11.35)	51.2 (11.26)

Adverse Events

Time Frame	Up to End-of-Study
Adverse Event Reporting Description	End-of-study means 8 weeks after last dose administration. i.e. If patient completed the study, End-of-study visit would be Week 62. If patient could not completed the study, End-of-study visit would be 8 weeks after last dose administration.
Arm/Group Title	CT-P13 - CT-P13		CT-P13 - Remicade		Remicade - Remicade		Remicade - CT-P13
Arm/Group Description	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		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		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		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
All-Cause Mortality
	CT-P13 - CT-P13		CT-P13 - Remicade		Remicade - Remicade		Remicade - CT-P13
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/56 (0.00%)		0/55 (0.00%)		0/54 (0.00%)		0/55 (0.00%)
Serious Adverse Events
	CT-P13 - CT-P13		CT-P13 - Remicade		Remicade - Remicade		Remicade - CT-P13
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/56 (7.14%)		4/55 (7.27%)		4/54 (7.41%)		7/55 (12.73%)
Blood and lymphatic system disorders
Anaemia †	1/56 (1.79%)	1	0/55 (0.00%)	0	0/54 (0.00%)	0	0/55 (0.00%)	0
Gastrointestinal disorders
Abdominal pain †	0/56 (0.00%)	0	1/55 (1.82%)	1	0/54 (0.00%)	0	0/55 (0.00%)	0
Anal fissure †	1/56 (1.79%)	1	0/55 (0.00%)	0	1/54 (1.85%)	1	0/55 (0.00%)	0
Anal fistula †	0/56 (0.00%)	0	0/55 (0.00%)	0	1/54 (1.85%)	1	0/55 (0.00%)	0
Duodenal ulcer haemorrhage †	0/56 (0.00%)	0	0/55 (0.00%)	0	0/54 (0.00%)	0	1/55 (1.82%)	1
Constipation †	0/56 (0.00%)	0	0/55 (0.00%)	0	0/54 (0.00%)	0	1/55 (1.82%)	1
Gastritis haemorrhagic †	0/56 (0.00%)	0	0/55 (0.00%)	0	0/54 (0.00%)	0	1/55 (1.82%)	1
Haematochezia †	0/56 (0.00%)	0	0/55 (0.00%)	0	0/54 (0.00%)	0	1/55 (1.82%)	1
Haemorrhoids †	1/56 (1.79%)	1	0/55 (0.00%)	0	0/54 (0.00%)	0	0/55 (0.00%)	0
Lower gastrointestinal haemorrhage †	0/56 (0.00%)	0	0/55 (0.00%)	0	0/54 (0.00%)	0	1/55 (1.82%)	1
General disorders
Generalised oedema †	0/56 (0.00%)	0	0/55 (0.00%)	0	1/54 (1.85%)	1	0/55 (0.00%)	0
Hepatobiliary disorders
Hepatitis †	0/56 (0.00%)	0	1/55 (1.82%)	1	0/54 (0.00%)	0	0/55 (0.00%)	0
Infections and infestations
Abscess intestinal †	0/56 (0.00%)	0	0/55 (0.00%)	0	0/54 (0.00%)	0	1/55 (1.82%)	1
Acute sinusitis †	0/56 (0.00%)	0	1/55 (1.82%)	1	0/54 (0.00%)	0	0/55 (0.00%)	0
Anal abscess †	1/56 (1.79%)	1	0/55 (0.00%)	0	0/54 (0.00%)	0	0/55 (0.00%)	0
Cellulitis †	0/56 (0.00%)	0	1/55 (1.82%)	1	0/54 (0.00%)	0	0/55 (0.00%)	0
Peritoneal tuberculosis †	1/56 (1.79%)	1	0/55 (0.00%)	0	0/54 (0.00%)	0	0/55 (0.00%)	0
Tuberculous pleurisy †	0/56 (0.00%)	0	0/55 (0.00%)	0	0/54 (0.00%)	0	1/55 (1.82%)	1
Injury, poisoning and procedural complications
Infusion related reaction †	0/56 (0.00%)	0	0/55 (0.00%)	0	1/54 (1.85%)	1	0/55 (0.00%)	0
Road traffic accident †	0/56 (0.00%)	0	0/55 (0.00%)	0	1/54 (1.85%)	1	0/55 (0.00%)	0
Nervous system disorders
Syncope †	0/56 (0.00%)	0	0/55 (0.00%)	0	0/54 (0.00%)	0	1/55 (1.82%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CT-P13 - CT-P13		CT-P13 - Remicade		Remicade - Remicade		Remicade - CT-P13
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/56 (66.07%)		36/55 (65.45%)		36/54 (66.67%)		40/55 (72.73%)
Blood and lymphatic system disorders
Anaemia †	5/56 (8.93%)	5	5/55 (9.09%)	5	5/54 (9.26%)	5	4/55 (7.27%)	4
Gastrointestinal disorders
Abdominal pain †	3/56 (5.36%)	3	8/55 (14.55%)	9	5/54 (9.26%)	7	4/55 (7.27%)	6
Diarrhoea †	1/56 (1.79%)	2	3/55 (5.45%)	3	3/54 (5.56%)	3	0/55 (0.00%)	0
Frequent bowel movements †	1/56 (1.79%)	2	3/55 (5.45%)	4	0/54 (0.00%)	0	1/55 (1.82%)	1
Nausea †	0/56 (0.00%)	0	3/55 (5.45%)	4	3/54 (5.56%)	3	0/55 (0.00%)	0
General disorders
Pyrexia †	0/56 (0.00%)	0	3/55 (5.45%)	3	0/54 (0.00%)	0	1/55 (1.82%)	1
Infections and infestations
Gastroenteritis †	1/56 (1.79%)	1	1/55 (1.82%)	1	1/54 (1.85%)	1	3/55 (5.45%)	3
Influenza †	2/56 (3.57%)	3	1/55 (1.82%)	1	1/54 (1.85%)	1	5/55 (9.09%)	6
Upper respiratory tract infection †	3/56 (5.36%)	3	1/55 (1.82%)	1	0/54 (0.00%)	0	0/55 (0.00%)	0
Injury, poisoning and procedural complications
Infusion-related reaction †	8/56 (14.29%)	13	2/55 (3.64%)	2	5/54 (9.26%)	7	4/55 (7.27%)	4
Investigations
Aspartate aminotransferase increased †	1/56 (1.79%)	1	1/55 (1.82%)	1	0/54 (0.00%)	0	3/55 (5.45%)	3
Blood creatine phosphokinase increased †	1/56 (1.79%)	1	1/55 (1.82%)	1	4/54 (7.41%)	5	3/55 (5.45%)	3
Gamma-glutamyltransferase increased †	3/56 (5.36%)	3	1/55 (1.82%)	1	0/54 (0.00%)	0	1/55 (1.82%)	1
Musculoskeletal and connective tissue disorders
Arthralgia †	3/56 (5.36%)	4	1/55 (1.82%)	1	4/54 (7.41%)	5	4/55 (7.27%)	4
Nervous system disorders
Dizziness †	2/56 (3.57%)	2	0/55 (0.00%)	0	0/54 (0.00%)	0	4/55 (7.27%)	4
Headache †	3/56 (5.36%)	3	1/55 (1.82%)	1	2/54 (3.70%)	2	3/55 (5.45%)	3
Skin and subcutaneous tissue disorders
Rash †	0/56 (0.00%)	0	1/55 (1.82%)	1	3/54 (5.56%)	4	0/55 (0.00%)	0
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: BoYoung Choi / Clinical Operation Team Leader
• Organization: Celltrion, Inc.
• Phone: +82-32-850-6594
• EMail: BoYoung.Choi@celltrion.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.

Dulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30.

Wong ECL, Buffone E, Lee SJ, Dulai PS, Marshall JK, Reinisch W, Narula N. End of Induction Patient-reported Outcomes Predict Clinical Remission but Not Endoscopic Remission in Crohn's Disease. J Crohns Colitis. 2021 Jul 5;15(7):1114-1119. doi: 10.1093/ecco-jcc/jjaa242.

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• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT02096861
• Other Study ID Numbers: CT-P13 3.4; 2013-004497-10 ( EudraCT Number )
• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Results First Submitted: February 14, 2018
• Results First Posted: April 11, 2018
• Last Update Posted: May 9, 2018