Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC

• ClinicalTrials.gov Identifier: NCT00094458
• Recruitment Status: Completed
• First Posted: October 20, 2004
• Results First Posted: June 23, 2009
• Last Update Posted: February 9, 2017
• Sponsor: Centocor Ortho Biotech Services, L.L.C.
• Collaborator: Schering-Plough
• Information provided by (Responsible Party): Centocor Ortho Biotech Services, L.L.C.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Crohn Disease
• Interventions: Biological: infliximab infusion; AZA placebo caps; Other: infliximab (IFX) infusion; azathioprine (AZA) caps; Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps
• Enrollment: 508

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine	Azathioprine + Placebo/Infliximab	Infliximab + Placebo/Infliximab	Infliximab + Azathioprine/Infliximab
Arm/Group Description	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received daily AZA oral capsules 2.5mg/kg/day and Placebo infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (EU and Israel) open-Label Extension.	Participants received Placebo oral capsules daily and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.	Participants received daily AZA oral capsules 2.5mg/kg/day and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
Period Title: Main Study: Through Week 30
Started	170	169	169	0	0	0
Completed	86	111	121	0	0	0
Not Completed	84	58	48	0	0	0
Reason Not Completed
Eligibility criteria not met	3	8	2	0	0	0
Lost to Follow-up	5	5	2	0	0	0
Withdrawal by Subject	18	9	7	0	0	0
Adverse Event	38	20	28	0	0	0
Death	1	0	0	0	0	0
Other	19	16	9	0	0	0
Period Title: Study Extension: Week 30 Through Week 50
Started	75	97	108	0	0	0
Completed	67	85	90	0	0	0
Not Completed	8	12	18	0	0	0
Reason Not Completed
Lost to Follow-up	2	1	4	0	0	0
Withdrawal by Subject	2	0	4	0	0	0
Adverse Event	3	9	7	0	0	0
Other	1	2	3	0	0	0
Period Title: OLE: Open-Label Extension
Started	0	0	0	8	18	17
Completed	0	0	0	7	13	13
Not Completed	0	0	0	1	5	4
Reason Not Completed
Adverse Event	0	0	0	0	3	4
Inadequate therapeutic effect	0	0	0	1	1	0
Patient decision	0	0	0	0	1	0

Baseline Characteristics

Arm/Group Title		Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine	Total
Arm/Group Description		Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Total of all reporting groups
Overall Number of Baseline Participants		170	169	169	508
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	170 participants	169 participants	169 participants	508 participants
		36.3 (12.92)	36.6 (13)	35.9 (11.97)	36.3 (12.62)
Gender; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	170 participants	169 participants	169 participants	508 participants
	Female	80 47.1%	85 50.3%	81 47.9%	246 48.4%
	Male	90 52.9%	84 49.7%	88 52.1%	262 51.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	170 participants	169 participants	169 participants	508 participants
AUSTRIA		8	9	8	25
BELGIUM		14	17	15	46
CANADA		9	7	7	23
DENMARK		5	8	4	17
FRANCE		9	12	18	39
GERMANY		17	8	13	38
GREECE		3	3	3	9
ISRAEL		7	13	12	32
NETHERLANDS		9	9	8	26
NORWAY		0	1	0	1
PORTUGAL		0	2	0	2
SPAIN		2	2	2	6
SWEDEN		0	1	2	3
UK		4	11	7	22
USA		83	66	70	219

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Corticosteriod-free Clinical Remission
Description	Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (>=) 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT) population includes all randomized participants in the analysis, according to the treatment group to which they were randomized, regardless of the treatment they actually received.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	170	169	169
Measure Type: Number; Unit of Measure: percentage of participants
	30.0	44.4	56.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Azathioprine + Placebo, Infliximab + Azathioprine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Azathioprine + Placebo, Infliximab + Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Infliximab + Placebo, Infliximab + Azathioprine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.022
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline

2. Secondary Outcome

Title	Percentage of Participants With Mucosal Healing
Description	Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Analysis population for mucosal healing was per protocol. All subjects with lesions at Baseline (Week 0) and an Endoscopy at Week 26 were included in the analysis. Here, 'N' [number of participants analyzed] signifies those participants who were evaluable for this measure.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	109	93	107
Measure Type: Number; Unit of Measure: percentage of participants
	16.5	30.1	43.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Azathioprine + Placebo, Infliximab + Azathioprine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Azathioprine + Placebo, Infliximab + Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.023
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Infliximab + Placebo, Infliximab + Azathioprine
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.055
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline

3. Secondary Outcome

Title	Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)
Description	Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) < 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for >= 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
Time Frame	Week 50

Outcome Measure Data

Analysis Population Description

Population analyzed included all randomized participants enrolled in Study Extension.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	75	97	108
Measure Type: Number; Unit of Measure: percentage of participants
	54.7	60.8	72.2

4. Secondary Outcome

Title	Percentage of Participants With Clinical Remission (Main Study)
Description	Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
Time Frame	Weeks 2, 6, 10, 18 and 26

Outcome Measure Data

Analysis Population Description

Population analyzed included all randomized participants enrolled in the main study.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	170	169	169
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	17.6	32.5	36.7
Week 6	27.6	49.1	52.1
Week 10	34.1	47.3	59.8
Week 18	33.5	49.7	60.4
Week 26	31.8	47.9	60.4

5. Secondary Outcome

Title	Percentage of Participants With Clinical Remission (Study Extension)
Description	Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
Time Frame	Weeks 34, 42 and 50

Outcome Measure Data

Analysis Population Description

Population analyzed included all randomized participants enrolled in the Study Extension.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	75	97	108
Measure Type: Number; Unit of Measure: percentage of participants
Week 34	61.3	66.0	69.4
Week 42	58.7	72.2	73.1
Week 50	54.7	66.0	74.1

6. Secondary Outcome

Title	Percentage of Participants With Clinical Response Over Time (Main Study)
Description	Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
Time Frame	Weeks 2, 6, 10, 18, 26

Outcome Measure Data

Analysis Population Description

Population analyzed included all randomized participants during the Main Study.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	170	169	169
Measure Type: Number; Unit of Measure: percentage of participants
Week 2	22.4	42.6	47.3
Week 6	37.6	54.4	63.3
Week 10	39.4	55.6	69.2
Week 18	38.8	55.0	62.7
Week 26	37.6	54.4	62.1

7. Secondary Outcome

Title	Percentage of Participants With Clinical Response Over Time (Study Extension)
Description	Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
Time Frame	Weeks 34, 42, 50

Outcome Measure Data

Analysis Population Description

Population analyzed included all randomized participants during the Study Extension.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	75	97	108
Measure Type: Number; Unit of Measure: percentage of participants
Week 34	66.7	76.3	76.9
Week 42	65.3	74.2	77.8
Week 50	62.7	72.2	78.7

8. Secondary Outcome

Title	Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)
Description	Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).
Time Frame	Baseline and Weeks 2, 6, 10, 18, 26

Outcome Measure Data

Analysis Population Description

Population analyzed included all randomized participants enrolled in Main Study with last observation carried forward method to impute missing data. 'n' signifies number of participants who were evaluable at specified time point, for each arm respectively.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	170	169	169
Mean (Standard Deviation); Unit of Measure: units on a scale
Week 2 (n= 160, 160, 163)	20.1 (24.29)	27.7 (26.08)	31.4 (29.60)
Week 6 (n= 162, 161, 165)	28.3 (31.25)	34.8 (31.79)	39.9 (32.90)
Week 10 (n= 162, 161, 165)	31.0 (31.66)	37.8 (35.56)	42.4 (34.67)
Week 18 (n= 162, 161, 165)	30.3 (33.92)	39.9 (34.17)	43.7 (34.56)
Week 26 (n= 162, 161, 165)	31.4 (35.43)	39.9 (36.62)	45.2 (35.76)

9. Secondary Outcome

Title	Average Corticosteroid Use
Description	Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)
Time Frame	Weeks 2, 6, 10, 18 and 26

Outcome Measure Data

Analysis Population Description

Population analyzed included all randomized participants taking corticosteroids for Crohn's disease. n' signifies number of participants who were evaluable at specified time point, for each arm respectively.

Arm/Group Title	Azathioprine + Placebo	Infliximab + Placebo	Infliximab + Azathioprine
Arm/Group Description:	Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.	Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Overall Number of Participants Analyzed	170	169	169
Mean (Standard Deviation); Unit of Measure: milligram per day
Week 2 (n=48, 50, 49)	22.92 (12.476)	21.20 (11.883)	22.75 (11.923)
Week 6 (n=53, 52, 51)	18.56 (11.588)	17.68 (10.993)	18.26 (11.635)
Week 10 (n=56, 56, 52)	16.19 (11.160)	15.68 (14.924)	15.01 (11.087)
Week 18 (n=59, 57, 56)	13.49 (10.929)	13.23 (17.206)	11.64 (10.904)
Week 26 (n=60, 60, 58)	11.57 (10.246)	10.96 (15.990)	9.35 (10.052)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	1 patient in AZA+PBO group(gp),3 in IFX+PBO gp,1 in IFX+AZA gp were randomized but not treated(Excluded from safety analyses).Safety population for IFX+AZA gp included 11 patients assigned to one of monotherapy gps but inadvertently were given at least one dose of both active oral and intravenous therapy(8 patients in AZA+PBO gp,3 in IFX+PBO gp).
Arm/Group Title	W30-Azathioprine + Placebo	W30-Infliximab + Placebo	W30-Infliximab + Azathioprine	W50-Azathioprine + Placebo	W50-Infliximab + Placebo	W50-Infliximab + Azathioprine	OLE-Azathioprine + Placebo/Infliximab	OLE-Infliximab + Placebo/Infliximab	OLE-Infliximab + Azathioprine/Infliximab
Arm/Group Description	Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30.	Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30.	Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30.	(AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50.	Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.	Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.	Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.	Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.	Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
All-Cause Mortality
	W30-Azathioprine + Placebo	W30-Infliximab + Placebo	W30-Infliximab + Azathioprine	W50-Azathioprine + Placebo	W50-Infliximab + Placebo	W50-Infliximab + Azathioprine	OLE-Azathioprine + Placebo/Infliximab	OLE-Infliximab + Placebo/Infliximab	OLE-Infliximab + Azathioprine/Infliximab
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events
	W30-Azathioprine + Placebo	W30-Infliximab + Placebo	W30-Infliximab + Azathioprine	W50-Azathioprine + Placebo	W50-Infliximab + Placebo	W50-Infliximab + Azathioprine	OLE-Azathioprine + Placebo/Infliximab	OLE-Infliximab + Placebo/Infliximab	OLE-Infliximab + Azathioprine/Infliximab
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	39/161 (24.22%)	26/163 (15.95%)	25/179 (13.97%)	5/75 (6.67%)	15/97 (15.46%)	2/108 (1.85%)	1/8 (12.50%)	1/18 (5.56%)	3/17 (17.65%)
Cardiac disorders
Myocardial Infarction * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Ear and labyrinth disorders
Vertigo * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Eye disorders
Papilloedema * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Gastrointestinal disorders
Abdominal Pain * 1	1/161 (0.62%)	1/163 (0.61%)	4/179 (2.23%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Abdominal Pain Upper * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Anal Fistula * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Colonic Stenosis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Crohn's Disease * 1	12/161 (7.45%)	7/163 (4.29%)	6/179 (3.35%)	1/75 (1.33%)	9/97 (9.28%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Diarrhoea * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Duodenal Stenosis * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Duodenal Ulcer * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Duodenitis * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Enterocolitis * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Enterocolonic Fistula * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Faecaloma * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Food Poisoning * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Gastritis * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Gastrointestinal Fistula * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Ileal Stenosis * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Intestinal Fistula * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Intestinal Obstruction * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Intestinal Perforation * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Intestinal Stenosis * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pancreatitis * 1	4/161 (2.48%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pancreatitis Acute * 1	4/161 (2.48%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Peritonitis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Small Intestinal Obstruction * 1	3/161 (1.86%)	3/163 (1.84%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Small Intestinal Stenosis * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Subileus * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Vomiting * 1	1/161 (0.62%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
General disorders
Asthenia * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Non-Cardiac Chest Pain * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Oedema Peripheral * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pyrexia * 1	1/161 (0.62%)	1/163 (0.61%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Hepatobiliary disorders
Hepatitis * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Hepatitis Acute * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Immune system disorders
Anaphylactoid Reaction * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Infections and infestations
Abdominal Abscess * 1	2/161 (1.24%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Abscess Intestinal * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Anal Abscess * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Appendicitis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Campylobacter Intestinal Infection * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Cellulitis * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Clostridium Difficile Colitis * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Erysipelas * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Gastroenteritis * 1	1/161 (0.62%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Gastroenteritis Viral * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Herpes Zoster * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Osteomyelitis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pelvic Abscess * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Perirectal Abscess * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pneumonia * 1	1/161 (0.62%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pneumonia Legionella * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pseudomembranous Colitis * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Psoas Abscess * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Retroperitoneal Abscess * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Sepsis * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Tooth Infection * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Tuberculosis * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Viral Infection * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Injury, poisoning and procedural complications
Anastomotic Leak * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Crush Injury * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Hand Fracture * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Rib Fracture * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Metabolism and nutrition disorders
Hypovolaemia * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Arthritis * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Myalgia * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Rotator Cuff Syndrome * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Colon Cancer * 1	2/161 (1.24%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Nervous system disorders
Cerebrovascular Accident * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Ischaemic Cerebral Infarction * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Migraine with Aura * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Paralysis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Ectopic Pregnancy * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Psychiatric disorders
Conversion Disorder * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Depression * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Psychotic Disorder * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Renal and urinary disorders
Nephrolithiasis * 1	0/161 (0.00%)	1/163 (0.61%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Renal Colic * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Urethral Stenosis * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Urinary Retention * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Reproductive system and breast disorders
Adenomyosis * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Female Genital Tract Fistula * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Ovarian Cyst * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pneumonitis * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Pneumothorax * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Skin and subcutaneous tissue disorders
Dyshidrosis * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Rash * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Skin Necrosis * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Social circumstances
Miscarriage of Partner * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Vascular disorders
Haematoma * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	W30-Azathioprine + Placebo	W30-Infliximab + Placebo	W30-Infliximab + Azathioprine	W50-Azathioprine + Placebo	W50-Infliximab + Placebo	W50-Infliximab + Azathioprine	OLE-Azathioprine + Placebo/Infliximab	OLE-Infliximab + Placebo/Infliximab	OLE-Infliximab + Azathioprine/Infliximab
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	120/161 (74.53%)	122/163 (74.85%)	133/179 (74.30%)	44/75 (58.67%)	69/97 (71.13%)	61/108 (56.48%)	7/8 (87.50%)	16/18 (88.89%)	15/17 (88.24%)
Blood and lymphatic system disorders
Anaemia * 1	5/161 (3.11%)	4/163 (2.45%)	2/179 (1.12%)	1/75 (1.33%)	2/97 (2.06%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Leukopenia * 1	3/161 (1.86%)	1/163 (0.61%)	10/179 (5.59%)	1/75 (1.33%)	0/97 (0.00%)	2/108 (1.85%)	0/8 (0.00%)	0/18 (0.00%)	0/17 (0.00%)
Lymphadenopathy * 1	2/161 (1.24%)	1/163 (0.61%)	1/179 (0.56%)	1/75 (1.33%)	0/97 (0.00%)	1/108 (0.93%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Cardiac disorders
Angina Pectoris * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Palpitations * 1	1/161 (0.62%)	1/163 (0.61%)	3/179 (1.68%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Ear and labyrinth disorders
Ear Pain * 1	0/161 (0.00%)	3/163 (1.84%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Eye disorders
Amaurosis Fugax * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Conjunctivitis * 1	1/161 (0.62%)	1/163 (0.61%)	1/179 (0.56%)	0/75 (0.00%)	1/97 (1.03%)	4/108 (3.70%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Eyelids Pruritus * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Ocular Hyperaemia * 1	1/161 (0.62%)	0/163 (0.00%)	1/179 (0.56%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Panophthalmitis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Uveitis * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Gastrointestinal disorders
Abdominal Discomfort * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Abdominal Distension * 1	3/161 (1.86%)	7/163 (4.29%)	4/179 (2.23%)	2/75 (2.67%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Abdominal Pain * 1	23/161 (14.29%)	34/163 (20.86%)	24/179 (13.41%)	3/75 (4.00%)	11/97 (11.34%)	10/108 (9.26%)	3/8 (37.50%)	5/18 (27.78%)	2/17 (11.76%)
Abdominal Pain Upper * 1	8/161 (4.97%)	8/163 (4.91%)	12/179 (6.70%)	1/75 (1.33%)	3/97 (3.09%)	1/108 (0.93%)	1/8 (12.50%)	4/18 (22.22%)	2/17 (11.76%)
Anal Haemorrhage * 1	0/161 (0.00%)	0/163 (0.00%)	2/179 (1.12%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Anal Ulcer * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Aphthous Stomatitis * 1	1/161 (0.62%)	1/163 (0.61%)	1/179 (0.56%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Constipation * 1	5/161 (3.11%)	5/163 (3.07%)	5/179 (2.79%)	0/75 (0.00%)	2/97 (2.06%)	1/108 (0.93%)	0/8 (0.00%)	2/18 (11.11%)	1/17 (5.88%)
Crohn's Disease * 1	14/161 (8.70%)	7/163 (4.29%)	10/179 (5.59%)	4/75 (5.33%)	10/97 (10.31%)	6/108 (5.56%)	1/8 (12.50%)	1/18 (5.56%)	1/17 (5.88%)
Diarrhoea * 1	11/161 (6.83%)	14/163 (8.59%)	11/179 (6.15%)	2/75 (2.67%)	7/97 (7.22%)	6/108 (5.56%)	2/8 (25.00%)	0/18 (0.00%)	0/17 (0.00%)
Dyspepsia * 1	2/161 (1.24%)	4/163 (2.45%)	9/179 (5.03%)	2/75 (2.67%)	1/97 (1.03%)	1/108 (0.93%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Gastrointestinal Pain * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Gastrointestinal Sounds Abnormal * 1	1/161 (0.62%)	1/163 (0.61%)	1/179 (0.56%)	2/75 (2.67%)	0/97 (0.00%)	0/108 (0.00%)	2/8 (25.00%)	0/18 (0.00%)	0/17 (0.00%)
Intestinal Obstruction * 1	0/161 (0.00%)	1/163 (0.61%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Nausea * 1	46/161 (28.57%)	27/163 (16.56%)	39/179 (21.79%)	7/75 (9.33%)	11/97 (11.34%)	6/108 (5.56%)	1/8 (12.50%)	2/18 (11.11%)	1/17 (5.88%)
Vomiting * 1	24/161 (14.91%)	13/163 (7.98%)	14/179 (7.82%)	5/75 (6.67%)	11/97 (11.34%)	1/108 (0.93%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
General disorders
Chest Discomfort * 1	1/161 (0.62%)	2/163 (1.23%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Cyst * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Fatigue * 1	22/161 (13.66%)	21/163 (12.88%)	24/179 (13.41%)	5/75 (6.67%)	4/97 (4.12%)	4/108 (3.70%)	2/8 (25.00%)	4/18 (22.22%)	6/17 (35.29%)
Inflammation * 1	2/161 (1.24%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Influenza Like Illness * 1	2/161 (1.24%)	1/163 (0.61%)	3/179 (1.68%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Malaise * 1	1/161 (0.62%)	1/163 (0.61%)	0/179 (0.00%)	2/75 (2.67%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	1/18 (5.56%)	0/17 (0.00%)
Oedema Peripheral * 1	3/161 (1.86%)	3/163 (1.84%)	4/179 (2.23%)	2/75 (2.67%)	0/97 (0.00%)	4/108 (3.70%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Pyrexia * 1	16/161 (9.94%)	10/163 (6.13%)	13/179 (7.26%)	1/75 (1.33%)	6/97 (6.19%)	5/108 (4.63%)	1/8 (12.50%)	1/18 (5.56%)	1/17 (5.88%)
Hepatobiliary disorders
Cholelithiasis * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Immune system disorders
Seasonal Allergy * 1	1/161 (0.62%)	4/163 (2.45%)	0/179 (0.00%)	0/75 (0.00%)	2/97 (2.06%)	0/108 (0.00%)	0/8 (0.00%)	2/18 (11.11%)	0/17 (0.00%)
Infections and infestations
Bronchitis * 1	2/161 (1.24%)	2/163 (1.23%)	8/179 (4.47%)	4/75 (5.33%)	1/97 (1.03%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	1/17 (5.88%)
Ear Infection * 1	2/161 (1.24%)	1/163 (0.61%)	2/179 (1.12%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	1/17 (5.88%)
Fungal Infection * 1	0/161 (0.00%)	2/163 (1.23%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Gastroenteritis * 1	1/161 (0.62%)	3/163 (1.84%)	2/179 (1.12%)	4/75 (5.33%)	2/97 (2.06%)	0/108 (0.00%)	3/8 (37.50%)	0/18 (0.00%)	0/17 (0.00%)
Gastroenteritis Viral * 1	7/161 (4.35%)	3/163 (1.84%)	2/179 (1.12%)	1/75 (1.33%)	3/97 (3.09%)	1/108 (0.93%)	1/8 (12.50%)	2/18 (11.11%)	0/17 (0.00%)
Herpes Zoster * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	1/75 (1.33%)	2/97 (2.06%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Impetigo * 1	1/161 (0.62%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Influenza * 1	2/161 (1.24%)	8/163 (4.91%)	6/179 (3.35%)	3/75 (4.00%)	1/97 (1.03%)	3/108 (2.78%)	2/8 (25.00%)	3/18 (16.67%)	3/17 (17.65%)
Laryngitis * 1	0/161 (0.00%)	1/163 (0.61%)	1/179 (0.56%)	2/75 (2.67%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Nasopharyngitis * 1	15/161 (9.32%)	13/163 (7.98%)	16/179 (8.94%)	11/75 (14.67%)	6/97 (6.19%)	9/108 (8.33%)	4/8 (50.00%)	3/18 (16.67%)	3/17 (17.65%)
Oral Herpes * 1	3/161 (1.86%)	4/163 (2.45%)	2/179 (1.12%)	0/75 (0.00%)	0/97 (0.00%)	1/108 (0.93%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Pharyngitis * 1	2/161 (1.24%)	8/163 (4.91%)	2/179 (1.12%)	0/75 (0.00%)	2/97 (2.06%)	2/108 (1.85%)	0/8 (0.00%)	1/18 (5.56%)	1/17 (5.88%)
Rhinitis * 1	4/161 (2.48%)	2/163 (1.23%)	4/179 (2.23%)	1/75 (1.33%)	1/97 (1.03%)	0/108 (0.00%)	1/8 (12.50%)	1/18 (5.56%)	1/17 (5.88%)
Sinusitis * 1	5/161 (3.11%)	2/163 (1.23%)	6/179 (3.35%)	3/75 (4.00%)	6/97 (6.19%)	1/108 (0.93%)	1/8 (12.50%)	1/18 (5.56%)	1/17 (5.88%)
Tinea Pedis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Tooth Abscess * 1	0/161 (0.00%)	1/163 (0.61%)	2/179 (1.12%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Upper Respiratory Tract Infection * 1	7/161 (4.35%)	3/163 (1.84%)	9/179 (5.03%)	4/75 (5.33%)	4/97 (4.12%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Vulvovaginal Mycotic Infection * 1	2/161 (1.24%)	2/163 (1.23%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Injury, poisoning and procedural complications
Arthropod Bite * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Epicondylitis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Face Injury * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Ligament Rupture * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Investigations
Alanine Aminotransferase Increased * 1	3/161 (1.86%)	8/163 (4.91%)	6/179 (3.35%)	0/75 (0.00%)	0/97 (0.00%)	2/108 (1.85%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Aspartate Aminotransferase Increased * 1	2/161 (1.24%)	6/163 (3.68%)	6/179 (3.35%)	1/75 (1.33%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Blood Albumin Abnormal * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Blood Alkaline Phosphatase Increased * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
C-Reactive Protein Abnormal * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
C-Reactive Protein Increased * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Hepatic Enzyme Increased * 1	2/161 (1.24%)	1/163 (0.61%)	3/179 (1.68%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Liver Function Test Abnormal * 1	3/161 (1.86%)	1/163 (0.61%)	2/179 (1.12%)	0/75 (0.00%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Weight Increased * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	14/161 (8.70%)	23/163 (14.11%)	17/179 (9.50%)	7/75 (9.33%)	10/97 (10.31%)	5/108 (4.63%)	3/8 (37.50%)	5/18 (27.78%)	2/17 (11.76%)
Back Pain * 1	7/161 (4.35%)	6/163 (3.68%)	5/179 (2.79%)	2/75 (2.67%)	5/97 (5.15%)	4/108 (3.70%)	2/8 (25.00%)	0/18 (0.00%)	1/17 (5.88%)
Lupus-Like Syndrome * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Muscle Rigidity * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Musculoskeletal Stiffness * 1	0/161 (0.00%)	1/163 (0.61%)	3/179 (1.68%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	1/18 (5.56%)	0/17 (0.00%)
Myalgia * 1	6/161 (3.73%)	8/163 (4.91%)	2/179 (1.12%)	0/75 (0.00%)	2/97 (2.06%)	0/108 (0.00%)	0/8 (0.00%)	2/18 (11.11%)	0/17 (0.00%)
Neck Pain * 1	1/161 (0.62%)	2/163 (1.23%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Osteopenia * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Pain in Extremity * 1	2/161 (1.24%)	5/163 (3.07%)	2/179 (1.12%)	1/75 (1.33%)	0/97 (0.00%)	2/108 (1.85%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Plantar Fasciitis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Spondyloarthropathy * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Skin * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Nervous system disorders
Dizziness * 1	6/161 (3.73%)	11/163 (6.75%)	10/179 (5.59%)	1/75 (1.33%)	2/97 (2.06%)	0/108 (0.00%)	1/8 (12.50%)	2/18 (11.11%)	0/17 (0.00%)
Headache * 1	19/161 (11.80%)	22/163 (13.50%)	22/179 (12.29%)	4/75 (5.33%)	9/97 (9.28%)	4/108 (3.70%)	2/8 (25.00%)	2/18 (11.11%)	1/17 (5.88%)
Hypoaesthesia * 1	3/161 (1.86%)	4/163 (2.45%)	0/179 (0.00%)	0/75 (0.00%)	2/97 (2.06%)	1/108 (0.93%)	0/8 (0.00%)	2/18 (11.11%)	0/17 (0.00%)
Lethargy * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Syncope Vasovagal * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	0/161 (0.00%)	0/163 (0.00%)	2/179 (1.12%)	0/75 (0.00%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	0/18 (0.00%)	2/17 (11.76%)
Psychiatric disorders
Anxiety * 1	1/161 (0.62%)	3/163 (1.84%)	2/179 (1.12%)	0/75 (0.00%)	1/97 (1.03%)	1/108 (0.93%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Depressed Mood * 1	0/161 (0.00%)	1/163 (0.61%)	1/179 (0.56%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Depression * 1	4/161 (2.48%)	5/163 (3.07%)	1/179 (0.56%)	0/75 (0.00%)	2/97 (2.06%)	2/108 (1.85%)	0/8 (0.00%)	1/18 (5.56%)	1/17 (5.88%)
Fear * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Insomnia * 1	5/161 (3.11%)	4/163 (2.45%)	1/179 (0.56%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	1/8 (12.50%)	1/18 (5.56%)	0/17 (0.00%)
Sleep Disorder * 1	0/161 (0.00%)	2/163 (1.23%)	2/179 (1.12%)	0/75 (0.00%)	1/97 (1.03%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	1/17 (5.88%)
Renal and urinary disorders
Dysuria * 1	4/161 (2.48%)	0/163 (0.00%)	1/179 (0.56%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Reproductive system and breast disorders
Endometriosis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthma * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	2/108 (1.85%)	0/8 (0.00%)	0/18 (0.00%)	2/17 (11.76%)
Chronic Obstructive Pulmonary Disease * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Cough * 1	7/161 (4.35%)	11/163 (6.75%)	2/179 (1.12%)	4/75 (5.33%)	1/97 (1.03%)	3/108 (2.78%)	0/8 (0.00%)	3/18 (16.67%)	3/17 (17.65%)
Dysphonia * 1	0/161 (0.00%)	1/163 (0.61%)	1/179 (0.56%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Dyspnoea * 1	2/161 (1.24%)	3/163 (1.84%)	5/179 (2.79%)	1/75 (1.33%)	1/97 (1.03%)	1/108 (0.93%)	0/8 (0.00%)	1/18 (5.56%)	1/17 (5.88%)
Oropharyngeal Pain * 1	5/161 (3.11%)	12/163 (7.36%)	5/179 (2.79%)	1/75 (1.33%)	2/97 (2.06%)	3/108 (2.78%)	2/8 (25.00%)	1/18 (5.56%)	2/17 (11.76%)
Productive Cough * 1	2/161 (1.24%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Sinus Disorder * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	0/18 (0.00%)	0/17 (0.00%)
Skin and subcutaneous tissue disorders
Acne * 1	3/161 (1.86%)	3/163 (1.84%)	4/179 (2.23%)	0/75 (0.00%)	0/97 (0.00%)	3/108 (2.78%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Alopecia * 1	4/161 (2.48%)	7/163 (4.29%)	7/179 (3.91%)	1/75 (1.33%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Dry Skin * 1	1/161 (0.62%)	2/163 (1.23%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	2/18 (11.11%)	1/17 (5.88%)
Eczema * 1	0/161 (0.00%)	1/163 (0.61%)	4/179 (2.23%)	1/75 (1.33%)	3/97 (3.09%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Erythema * 1	1/161 (0.62%)	0/163 (0.00%)	2/179 (1.12%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Exfoliative Rash * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Night Sweats * 1	4/161 (2.48%)	1/163 (0.61%)	2/179 (1.12%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Pain of Skin * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Photosensitivity Reaction * 1	1/161 (0.62%)	1/163 (0.61%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	0/108 (0.00%)	1/8 (12.50%)	1/18 (5.56%)	0/17 (0.00%)
Pityriasis * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Pruritus * 1	5/161 (3.11%)	2/163 (1.23%)	3/179 (1.68%)	1/75 (1.33%)	1/97 (1.03%)	0/108 (0.00%)	1/8 (12.50%)	1/18 (5.56%)	1/17 (5.88%)
Rash * 1	9/161 (5.59%)	7/163 (4.29%)	9/179 (5.03%)	0/75 (0.00%)	1/97 (1.03%)	2/108 (1.85%)	1/8 (12.50%)	1/18 (5.56%)	0/17 (0.00%)
Seborrhoeic Dermatitis * 1	0/161 (0.00%)	0/163 (0.00%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Social circumstances
Pregnancy of Partner * 1	1/161 (0.62%)	0/163 (0.00%)	0/179 (0.00%)	1/75 (1.33%)	0/97 (0.00%)	2/108 (1.85%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Surgical and medical procedures
Tooth Extraction * 1	0/161 (0.00%)	0/163 (0.00%)	1/179 (0.56%)	0/75 (0.00%)	0/97 (0.00%)	1/108 (0.93%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
Vascular disorders
Haematoma * 1	0/161 (0.00%)	1/163 (0.61%)	0/179 (0.00%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	0/18 (0.00%)	1/17 (5.88%)
Hypertension * 1	3/161 (1.86%)	5/163 (3.07%)	3/179 (1.68%)	0/75 (0.00%)	0/97 (0.00%)	0/108 (0.00%)	0/8 (0.00%)	1/18 (5.56%)	0/17 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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: Study Director
• Organization: Centocor Ortho Biotech Services, L.L.C.
• Phone: 215 325-7405

Publications of Results:

Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

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

Colombel JF, Adedokun OJ, Gasink C, Gao LL, Cornillie FJ, D'Haens GR, Rutgeerts PJ, Reinisch W, Sandborn WJ, Hanauer SB. Combination Therapy With Infliximab and Azathioprine Improves Infliximab Pharmacokinetic Features and Efficacy: A Post Hoc Analysis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1525-1532.e1. doi: 10.1016/j.cgh.2018.09.033. Epub 2018 Sep 26.

Colombel JF, Reinisch W, Mantzaris GJ, Kornbluth A, Rutgeerts P, Tang KL, Oortwijn A, Bevelander GS, Cornillie FJ, Sandborn WJ. Randomised clinical trial: deep remission in biologic and immunomodulator naïve patients with Crohn's disease - a SONIC post hoc analysis. Aliment Pharmacol Ther. 2015 Apr;41(8):734-46. doi: 10.1111/apt.13139. Epub 2015 Mar 1.

Reinisch W, Colombel JF, Sandborn WJ, Mantzaris GJ, Kornbluth A, Adedokun OJ, Miller M, Tang KL, Rutgeerts P, Cornillie F. Factors associated with short- and long-term outcomes of therapy for Crohn's disease. Clin Gastroenterol Hepatol. 2015 Mar;13(3):539-547.e2. doi: 10.1016/j.cgh.2014.09.031. Epub 2014 Sep 19.

Peyrin-Biroulet L, Reinisch W, Colombel JF, Mantzaris GJ, Kornbluth A, Diamond R, Rutgeerts P, Tang LK, Cornillie FJ, Sandborn WJ. Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn's disease in the SONIC trial. Gut. 2014 Jan;63(1):88-95. doi: 10.1136/gutjnl-2013-304984. Epub 2013 Aug 23.

Ferrante M, Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens GR, van der Woude CJ, Danese S, Diamond RH, Oortwijn AF, Tang KL, Miller M, Cornillie F, Rutgeerts PJ; International Organization for the Study of Inflammatory Bowel Diseases. Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. Gastroenterology. 2013 Nov;145(5):978-986.e5. doi: 10.1053/j.gastro.2013.08.010. Epub 2013 Aug 14.

• Responsible Party: Centocor Ortho Biotech Services, L.L.C.
• ClinicalTrials.gov Identifier: NCT00094458
• Other Study ID Numbers: CR004804; C0168T67
• First Submitted: October 19, 2004
• First Posted: October 20, 2004
• Results First Submitted: April 30, 2009
• Results First Posted: June 23, 2009
• Last Update Posted: February 9, 2017