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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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azathioprine + Placebo Infliximab + Placebo Infliximab + Azathioprine Azathioprine + Placebo/Infliximab Infliximab + Placebo/Infliximab Infliximab + Azathioprine/Infliximab
Hide 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
Arm/Group Title Azathioprine + Placebo Infliximab + Placebo Infliximab + Azathioprine Total
Hide 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
Hide 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
1.Primary Outcome
Title Percentage of Participants With Corticosteriod-free Clinical Remission
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide Description Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.
Time Frame Week 26
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all randomized participants enrolled in Study Extension.
Arm/Group Title Azathioprine + Placebo Infliximab + Placebo Infliximab + Azathioprine
Hide 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)
Hide Description Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
Time Frame Weeks 2, 6, 10, 18 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all randomized participants enrolled in the main study.
Arm/Group Title Azathioprine + Placebo Infliximab + Placebo Infliximab + Azathioprine
Hide 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)
Hide Description Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
Time Frame Weeks 34, 42 and 50
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all randomized participants enrolled in the Study Extension.
Arm/Group Title Azathioprine + Placebo Infliximab + Placebo Infliximab + Azathioprine
Hide 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)
Hide Description Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
Time Frame Weeks 2, 6, 10, 18, 26
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all randomized participants during the Main Study.
Arm/Group Title Azathioprine + Placebo Infliximab + Placebo Infliximab + Azathioprine
Hide 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)
Hide Description Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
Time Frame Weeks 34, 42, 50
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all randomized participants during the Study Extension.
Arm/Group Title Azathioprine + Placebo Infliximab + Placebo Infliximab + Azathioprine
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)
Time Frame Weeks 2, 6, 10, 18 and 26
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Centocor Ortho Biotech Services, L.L.C.
Phone: 215 325-7405
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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