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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

Sponsor
Centocor Ortho Biotech Services, L.L.C. (Industry)
Overall Status
Completed
CT.gov ID
NCT00094458
Collaborator
Schering-Plough (Industry)
508
Enrollment
116
Locations
3
Arms
57
Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.

Condition or Disease Intervention/Treatment Phase
  • Biological: infliximab infusion; AZA placebo caps
  • Other: infliximab (IFX) infusion; azathioprine (AZA) caps
  • Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps
 Phase 3

Detailed Description

Crohns disease is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sores) of the intestines. Crohns disease is treated with medications that decrease inflammation, and reduce diarrhea, abdominal pain and other symptoms of Crohns disease. In addition, Crohns disease can be treated with medications that suppress the immune system (the body system involved in inflammation and infections) or with surgery. This study will investigate the effectiveness of infliximab and azathioprine in the treatment of patients with moderate-to-severe Crohns disease. Infliximab is currently approved by the FDA for the treatment of both Crohns disease and rheumatoid arthritis. Azathioprine, which is an investigational drug, has not been approved by the FDA for the treatment of Crohns disease, but it is a well-established therapy that has been used for many years to treat Crohns disease. This study seeks to determine whether infliximab, azathioprine, or the combination of both drugs would be the most appropriate treatment for Crohns disease patients who have not responded well to certain drugs called 5-ASA drugs (e.g. Asacol, Pentasa, sulfasalazine) and/or require frequent treatment with corticosteroids. This research study will involve approximately 500 patients. Patients may participate in the main study for up to 34 weeks (approximately 8 months). During the main study, patients will be asked to visit the study center for 10 visits. If patients enroll into the extension of the study, the total time for participation may be up to 54 weeks (approximately 13 months). Patients enrolled in the Study Extension will be asked to visit the study center for an additional 5 visits. A country-specific (EU and Israel only), prospective, multi-center, open-label extension of the study will further evaluate the long-term safety and efficacy of scheduled maintenance therapy with infliximab in patients with Crohns Disease. Patients who have completed treatment through Week 50 in the SONIC main study and who, in the opinion of the investigator, would benefit from infliximab treatment may enter the open-label extension. Patients will be randomly assigned to one of three treatment groups (either infliximab plus placebo capsules, infliximab plus azathioprine, or azathioprine plus placebo infusions - there is no possibility of being assigned to placebo only in this trial - patients will receive one or both of these medications) at the beginning of the study. Oral medication will be taken daily. There are 5 infusion (which will be either infliximab or placebo) visits during the main study.

Study Design

Study Type:
Interventional
Actual Enrollment :
508 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 003

infliximab (IFX) infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22

Other: infliximab (IFX) infusion; azathioprine (AZA) caps
AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22
Experimental: 001

infliximab (IFX) placebo infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22

Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps
AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22
Experimental: 002

infliximab infusion; AZA placebo caps Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules

Biological: infliximab infusion; AZA placebo caps
Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Corticosteriod-free Clinical Remission [Week 26]

    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).

Secondary Outcome Measures

  1. Percentage of Participants With Mucosal Healing [Week 26]

    Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.

  2. Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension) [Week 50]

    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).

  3. Percentage of Participants With Clinical Remission (Main Study) [Weeks 2, 6, 10, 18 and 26]

    Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)

  4. Percentage of Participants With Clinical Remission (Study Extension) [Weeks 34, 42 and 50]

    Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)

  5. Percentage of Participants With Clinical Response Over Time (Main Study) [Weeks 2, 6, 10, 18, 26]

    Clinical response, defined as a >=100-point decrease in CDAI from Baseline.

  6. Percentage of Participants With Clinical Response Over Time (Study Extension) [Weeks 34, 42, 50]

    Clinical response, defined as a >=100-point decrease in CDAI from Baseline.

  7. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study) [Baseline and Weeks 2, 6, 10, 18, 26]

    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).

  8. Average Corticosteroid Use [Weeks 2, 6, 10, 18 and 26]

    Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosis of Crohns Disease for at least 6 weeks

  • Moderate to severe disease activity (CDAI >= 220 and <=450)

  • No history of azathioprine, 6-MP (6 Mercaptopurine), or biologic treatments

  • Are either: Corticosteriod-dependent, OR considered for a 2nd (or greater) course of corticosteriod, OR 5-ASA failures, Or Budesonide failures

Exclusion Criteria:

  • History of abdominal surgery within the last 6 months

  • Have an ostomy or stoma [An operation to create an opening from an area inside the body to the outside]

  • Are pregnant, nursing, or planning pregnancy (both men and women)

  • Serious simultaneous illness that could interfere with study participation

  • Use of any investigational drug within 30 days

  • Have a concomitant diagnosis or any history of congestive heart failure

  • Weigh more than 140 kilograms (or 310 pounds)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Alabama United States
2 Phoenix Arizona United States
3 Orange California United States
4 Roseville California United States
5 San Diego California United States
6 San Luis Obispo California United States
7 Golden Colorado United States
8 Littleton Colorado United States
9 Hartford Connecticut United States
10 Gainesville Florida United States
11 Jacksonville Florida United States
12 N Miami Beach Florida United States
13 Winter Park Florida United States
14 Austell Georgia United States
15 Decatur Georgia United States
16 Savannah Georgia United States
17 Peoria Illinois United States
18 Clive Iowa United States
19 Overland Park Kansas United States
20 Topeka Kansas United States
21 Baton Rouge Louisiana United States
22 Metairie Louisiana United States
23 Troy Michigan United States
24 Plymouth Minnesota United States
25 Rochester Minnesota United States
26 Ocean Springs Mississippi United States
27 Tupelo Mississippi United States
28 Saint Louis Missouri United States
29 Urbana Missouri United States
30 Lincoln Nebraska United States
31 Egg Harbor Township New Jersey United States
32 Great Neck New York United States
33 New Hyde Park New York United States
34 New York New York United States
35 Asheville North Carolina United States
36 Charlotte North Carolina United States
37 Raleigh North Carolina United States
38 Wilmington North Carolina United States
39 Bend Oregon United States
40 Portland Oregon United States
41 Hatfield Pennsylvania United States
42 Lancaster Pennsylvania United States
43 Philadelphia Pennsylvania United States
44 Pittsburgh Pennsylvania United States
45 Columbia South Carolina United States
46 Austin Texas United States
47 Houston Texas United States
48 San Antonio Texas United States
49 Bellevue Washington United States
50 Spokane Washington United States
51 Tacoma Washington United States
52 Hall In Tirol Austria
53 Wien Austria
54 Bonheiden Belgium
55 Bruxelles Belgium
56 Leuven Belgium
57 Liege Belgium
58 Roeselare Belgium
59 Montreal Ontario Canada
60 Toronto Ontario Canada
61 Quebec Canada
62 Aalborg Denmark
63 Aarhus C. Denmark
64 Helsinge Denmark
65 Amiens Cedex 1 France
66 Bordeaux France
67 Caen France
68 Grenoble France
69 Lille France
70 Nancy France
71 Paris France
72 Toulouse France
73 Berlin Germany
74 Frankfurt/Main Germany
75 Hamburg Germany
76 Hannover Germany
77 Herne Germany
78 Kiel Germany
79 Magdeburg Germany
80 Mainz Germany
81 Minden Germany
82 Munchen Germany
83 Munster Germany
84 Athens Greece
85 Exohi Greece
86 Heraklion- Crete Greece
87 Nicea Greece
88 Haifa Israel
89 Jerusalem Israel
90 Kfar Saba Israel
91 Petah Tikva Israel
92 Tel-Aviv Israel
93 Dordrecht Netherlands
94 Eindhoven Netherlands
95 Rotterdam Netherlands
96 Oslo N/A Norway
97 Oslo Norway
98 Amadora Portugal
99 Coimbra Portugal
100 Barcelona Spain
101 Madrid Spain
102 Santander Spain
103 Santiago De Compostela Spain
104 Sevilla Spain
105 Valencia Spain
106 Linköping Sweden
107 Lund Sweden
108 Stockhollm Sweden
109 Stockholm Sweden
110 Bristol United Kingdom
111 Cambridge United Kingdom
112 Leeds United Kingdom
113 Livingston United Kingdom
114 London United Kingdom
115 Newcastle Upon Tyne United Kingdom
116 Stockport United Kingdom

Sponsors and Collaborators

  • Centocor Ortho Biotech Services, L.L.C.
  • Schering-Plough

Investigators

  • Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial, Centocor Ortho Biotech Services, L.L.C.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00094458
Other Study ID Numbers:
  • CR004804
  • C0168T67
First Posted:
Oct 20, 2004
Last Update Posted:
Feb 9, 2017
Last Verified:
Dec 1, 2016
Keywords provided by Centocor Ortho Biotech Services, L.L.C.
Crohn's Disease
infliximab
azathioprine
Remicade
SONIC
Additional relevant MeSH terms:
Crohn Disease
Azathioprine
Infliximab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
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
Period Title: Main Study: Through Week 30
STARTED 75 97 108 0 0 0
COMPLETED 67 85 90 0 0 0
NOT COMPLETED 8 12 18 0 0 0
Period Title: Main Study: Through Week 30
STARTED 0 0 0 8 18 17
COMPLETED 0 0 0 7 13 13
NOT COMPLETED 0 0 0 1 5 4

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 Participants 170 169 169 508
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
36.3
(12.92)
36.6
(13)
35.9
(11.97)
36.3
(12.62)
Gender (Count of 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 (participants) [Number]
AUSTRIA
8
4.7%
9
5.3%
8
4.7%
25
4.9%
BELGIUM
14
8.2%
17
10.1%
15
8.9%
46
9.1%
CANADA
9
5.3%
7
4.1%
7
4.1%
23
4.5%
DENMARK
5
2.9%
8
4.7%
4
2.4%
17
3.3%
FRANCE
9
5.3%
12
7.1%
18
10.7%
39
7.7%
GERMANY
17
10%
8
4.7%
13
7.7%
38
7.5%
GREECE
3
1.8%
3
1.8%
3
1.8%
9
1.8%
ISRAEL
7
4.1%
13
7.7%
12
7.1%
32
6.3%
NETHERLANDS
9
5.3%
9
5.3%
8
4.7%
26
5.1%
NORWAY
0
0%
1
0.6%
0
0%
1
0.2%
PORTUGAL
0
0%
2
1.2%
0
0%
2
0.4%
SPAIN
2
1.2%
2
1.2%
2
1.2%
6
1.2%
SWEDEN
0
0%
1
0.6%
2
1.2%
3
0.6%
UK
4
2.4%
11
6.5%
7
4.1%
22
4.3%
USA
83
48.8%
66
39.1%
70
41.4%
219
43.1%

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.
Measure Participants 170 169 169
Number [percentage of participants]
30.0
17.6%
44.4
26.3%
56.8
33.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azathioprine + Placebo, Infliximab + Azathioprine
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
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
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.006
Comments
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
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.022
Comments
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.
Measure Participants 109 93 107
Number [percentage of participants]
16.5
9.7%
30.1
17.8%
43.9
26%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azathioprine + Placebo, Infliximab + Azathioprine
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
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
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.023
Comments
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
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.055
Comments
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.
Measure Participants 75 97 108
Number [percentage of participants]
54.7
32.2%
60.8
36%
72.2
42.7%
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.
Measure Participants 170 169 169
Week 2
17.6
10.4%
32.5
19.2%
36.7
21.7%
Week 6
27.6
16.2%
49.1
29.1%
52.1
30.8%
Week 10
34.1
20.1%
47.3
28%
59.8
35.4%
Week 18
33.5
19.7%
49.7
29.4%
60.4
35.7%
Week 26
31.8
18.7%
47.9
28.3%
60.4
35.7%
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.
Measure Participants 75 97 108
Week 34
61.3
36.1%
66.0
39.1%
69.4
41.1%
Week 42
58.7
34.5%
72.2
42.7%
73.1
43.3%
Week 50
54.7
32.2%
66.0
39.1%
74.1
43.8%
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.
Measure Participants 170 169 169
Week 2
22.4
13.2%
42.6
25.2%
47.3
28%
Week 6
37.6
22.1%
54.4
32.2%
63.3
37.5%
Week 10
39.4
23.2%
55.6
32.9%
69.2
40.9%
Week 18
38.8
22.8%
55.0
32.5%
62.7
37.1%
Week 26
37.6
22.1%
54.4
32.2%
62.1
36.7%
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.
Measure Participants 75 97 108
Week 34
66.7
39.2%
76.3
45.1%
76.9
45.5%
Week 42
65.3
38.4%
74.2
43.9%
77.8
46%
Week 50
62.7
36.9%
72.2
42.7%
78.7
46.6%
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.
Measure Participants 170 169 169
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.
Measure Participants 170 169 169
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
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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 39/161 (24.2%) 26/163 (16%) 25/179 (14%) 5/75 (6.7%) 15/97 (15.5%) 2/108 (1.9%) 1/8 (12.5%) 1/18 (5.6%) 3/17 (17.6%)
Cardiac disorders
Myocardial Infarction 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Ear and labyrinth disorders
Vertigo 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Eye disorders
Papilloedema 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Gastrointestinal disorders
Abdominal Pain 1/161 (0.6%) 1/163 (0.6%) 4/179 (2.2%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Abdominal Pain Upper 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Anal Fistula 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Colonic Stenosis 0/161 (0%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Crohn's Disease 12/161 (7.5%) 7/163 (4.3%) 6/179 (3.4%) 1/75 (1.3%) 9/97 (9.3%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Diarrhoea 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Duodenal Stenosis 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Duodenal Ulcer 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Duodenitis 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Enterocolitis 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Enterocolonic Fistula 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Faecaloma 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Food Poisoning 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Gastritis 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Gastrointestinal Fistula 0/161 (0%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Ileal Stenosis 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Intestinal Fistula 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Intestinal Obstruction 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Intestinal Perforation 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Intestinal Stenosis 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pancreatitis 4/161 (2.5%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pancreatitis Acute 4/161 (2.5%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Peritonitis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Small Intestinal Obstruction 3/161 (1.9%) 3/163 (1.8%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Small Intestinal Stenosis 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Subileus 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Vomiting 1/161 (0.6%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
General disorders
Asthenia 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Non-Cardiac Chest Pain 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Oedema Peripheral 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pyrexia 1/161 (0.6%) 1/163 (0.6%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Hepatobiliary disorders
Hepatitis 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Hepatitis Acute 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Immune system disorders
Anaphylactoid Reaction 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Infections and infestations
Abdominal Abscess 2/161 (1.2%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Abscess Intestinal 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Anal Abscess 0/161 (0%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Appendicitis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Campylobacter Intestinal Infection 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Cellulitis 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Clostridium Difficile Colitis 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Erysipelas 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Gastroenteritis 1/161 (0.6%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Gastroenteritis Viral 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Herpes Zoster 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Osteomyelitis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pelvic Abscess 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Perirectal Abscess 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pneumonia 1/161 (0.6%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pneumonia Legionella 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pseudomembranous Colitis 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Psoas Abscess 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Retroperitoneal Abscess 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Sepsis 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Tooth Infection 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Tuberculosis 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Viral Infection 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Injury, poisoning and procedural complications
Anastomotic Leak 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Crush Injury 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Hand Fracture 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Rib Fracture 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Metabolism and nutrition disorders
Hypovolaemia 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Arthritis 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Myalgia 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Rotator Cuff Syndrome 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Colon Cancer 2/161 (1.2%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Nervous system disorders
Cerebrovascular Accident 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Ischaemic Cerebral Infarction 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Migraine with Aura 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Paralysis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Ectopic Pregnancy 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Psychiatric disorders
Conversion Disorder 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Depression 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Psychotic Disorder 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Renal and urinary disorders
Nephrolithiasis 0/161 (0%) 1/163 (0.6%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Renal Colic 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Urethral Stenosis 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Urinary Retention 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Reproductive system and breast disorders
Adenomyosis 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Female Genital Tract Fistula 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Ovarian Cyst 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pneumonitis 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Pneumothorax 0/161 (0%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Skin and subcutaneous tissue disorders
Dyshidrosis 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Rash 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Skin Necrosis 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Social circumstances
Miscarriage of Partner 0/161 (0%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Vascular disorders
Haematoma 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Other (Not Including 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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 120/161 (74.5%) 122/163 (74.8%) 133/179 (74.3%) 44/75 (58.7%) 69/97 (71.1%) 61/108 (56.5%) 7/8 (87.5%) 16/18 (88.9%) 15/17 (88.2%)
Blood and lymphatic system disorders
Anaemia 5/161 (3.1%) 4/163 (2.5%) 2/179 (1.1%) 1/75 (1.3%) 2/97 (2.1%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Leukopenia 3/161 (1.9%) 1/163 (0.6%) 10/179 (5.6%) 1/75 (1.3%) 0/97 (0%) 2/108 (1.9%) 0/8 (0%) 0/18 (0%) 0/17 (0%)
Lymphadenopathy 2/161 (1.2%) 1/163 (0.6%) 1/179 (0.6%) 1/75 (1.3%) 0/97 (0%) 1/108 (0.9%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Cardiac disorders
Angina Pectoris 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Palpitations 1/161 (0.6%) 1/163 (0.6%) 3/179 (1.7%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Ear and labyrinth disorders
Ear Pain 0/161 (0%) 3/163 (1.8%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Eye disorders
Amaurosis Fugax 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Conjunctivitis 1/161 (0.6%) 1/163 (0.6%) 1/179 (0.6%) 0/75 (0%) 1/97 (1%) 4/108 (3.7%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Eyelids Pruritus 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Ocular Hyperaemia 1/161 (0.6%) 0/163 (0%) 1/179 (0.6%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Panophthalmitis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Uveitis 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Gastrointestinal disorders
Abdominal Discomfort 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Abdominal Distension 3/161 (1.9%) 7/163 (4.3%) 4/179 (2.2%) 2/75 (2.7%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Abdominal Pain 23/161 (14.3%) 34/163 (20.9%) 24/179 (13.4%) 3/75 (4%) 11/97 (11.3%) 10/108 (9.3%) 3/8 (37.5%) 5/18 (27.8%) 2/17 (11.8%)
Abdominal Pain Upper 8/161 (5%) 8/163 (4.9%) 12/179 (6.7%) 1/75 (1.3%) 3/97 (3.1%) 1/108 (0.9%) 1/8 (12.5%) 4/18 (22.2%) 2/17 (11.8%)
Anal Haemorrhage 0/161 (0%) 0/163 (0%) 2/179 (1.1%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Anal Ulcer 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Aphthous Stomatitis 1/161 (0.6%) 1/163 (0.6%) 1/179 (0.6%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Constipation 5/161 (3.1%) 5/163 (3.1%) 5/179 (2.8%) 0/75 (0%) 2/97 (2.1%) 1/108 (0.9%) 0/8 (0%) 2/18 (11.1%) 1/17 (5.9%)
Crohn's Disease 14/161 (8.7%) 7/163 (4.3%) 10/179 (5.6%) 4/75 (5.3%) 10/97 (10.3%) 6/108 (5.6%) 1/8 (12.5%) 1/18 (5.6%) 1/17 (5.9%)
Diarrhoea 11/161 (6.8%) 14/163 (8.6%) 11/179 (6.1%) 2/75 (2.7%) 7/97 (7.2%) 6/108 (5.6%) 2/8 (25%) 0/18 (0%) 0/17 (0%)
Dyspepsia 2/161 (1.2%) 4/163 (2.5%) 9/179 (5%) 2/75 (2.7%) 1/97 (1%) 1/108 (0.9%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Gastrointestinal Pain 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Gastrointestinal Sounds Abnormal 1/161 (0.6%) 1/163 (0.6%) 1/179 (0.6%) 2/75 (2.7%) 0/97 (0%) 0/108 (0%) 2/8 (25%) 0/18 (0%) 0/17 (0%)
Intestinal Obstruction 0/161 (0%) 1/163 (0.6%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Nausea 46/161 (28.6%) 27/163 (16.6%) 39/179 (21.8%) 7/75 (9.3%) 11/97 (11.3%) 6/108 (5.6%) 1/8 (12.5%) 2/18 (11.1%) 1/17 (5.9%)
Vomiting 24/161 (14.9%) 13/163 (8%) 14/179 (7.8%) 5/75 (6.7%) 11/97 (11.3%) 1/108 (0.9%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
General disorders
Chest Discomfort 1/161 (0.6%) 2/163 (1.2%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Cyst 0/161 (0%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Fatigue 22/161 (13.7%) 21/163 (12.9%) 24/179 (13.4%) 5/75 (6.7%) 4/97 (4.1%) 4/108 (3.7%) 2/8 (25%) 4/18 (22.2%) 6/17 (35.3%)
Inflammation 2/161 (1.2%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Influenza Like Illness 2/161 (1.2%) 1/163 (0.6%) 3/179 (1.7%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Malaise 1/161 (0.6%) 1/163 (0.6%) 0/179 (0%) 2/75 (2.7%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 1/18 (5.6%) 0/17 (0%)
Oedema Peripheral 3/161 (1.9%) 3/163 (1.8%) 4/179 (2.2%) 2/75 (2.7%) 0/97 (0%) 4/108 (3.7%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Pyrexia 16/161 (9.9%) 10/163 (6.1%) 13/179 (7.3%) 1/75 (1.3%) 6/97 (6.2%) 5/108 (4.6%) 1/8 (12.5%) 1/18 (5.6%) 1/17 (5.9%)
Hepatobiliary disorders
Cholelithiasis 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Immune system disorders
Seasonal Allergy 1/161 (0.6%) 4/163 (2.5%) 0/179 (0%) 0/75 (0%) 2/97 (2.1%) 0/108 (0%) 0/8 (0%) 2/18 (11.1%) 0/17 (0%)
Infections and infestations
Bronchitis 2/161 (1.2%) 2/163 (1.2%) 8/179 (4.5%) 4/75 (5.3%) 1/97 (1%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 1/17 (5.9%)
Ear Infection 2/161 (1.2%) 1/163 (0.6%) 2/179 (1.1%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 1/17 (5.9%)
Fungal Infection 0/161 (0%) 2/163 (1.2%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Gastroenteritis 1/161 (0.6%) 3/163 (1.8%) 2/179 (1.1%) 4/75 (5.3%) 2/97 (2.1%) 0/108 (0%) 3/8 (37.5%) 0/18 (0%) 0/17 (0%)
Gastroenteritis Viral 7/161 (4.3%) 3/163 (1.8%) 2/179 (1.1%) 1/75 (1.3%) 3/97 (3.1%) 1/108 (0.9%) 1/8 (12.5%) 2/18 (11.1%) 0/17 (0%)
Herpes Zoster 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 1/75 (1.3%) 2/97 (2.1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Impetigo 1/161 (0.6%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Influenza 2/161 (1.2%) 8/163 (4.9%) 6/179 (3.4%) 3/75 (4%) 1/97 (1%) 3/108 (2.8%) 2/8 (25%) 3/18 (16.7%) 3/17 (17.6%)
Laryngitis 0/161 (0%) 1/163 (0.6%) 1/179 (0.6%) 2/75 (2.7%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Nasopharyngitis 15/161 (9.3%) 13/163 (8%) 16/179 (8.9%) 11/75 (14.7%) 6/97 (6.2%) 9/108 (8.3%) 4/8 (50%) 3/18 (16.7%) 3/17 (17.6%)
Oral Herpes 3/161 (1.9%) 4/163 (2.5%) 2/179 (1.1%) 0/75 (0%) 0/97 (0%) 1/108 (0.9%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Pharyngitis 2/161 (1.2%) 8/163 (4.9%) 2/179 (1.1%) 0/75 (0%) 2/97 (2.1%) 2/108 (1.9%) 0/8 (0%) 1/18 (5.6%) 1/17 (5.9%)
Rhinitis 4/161 (2.5%) 2/163 (1.2%) 4/179 (2.2%) 1/75 (1.3%) 1/97 (1%) 0/108 (0%) 1/8 (12.5%) 1/18 (5.6%) 1/17 (5.9%)
Sinusitis 5/161 (3.1%) 2/163 (1.2%) 6/179 (3.4%) 3/75 (4%) 6/97 (6.2%) 1/108 (0.9%) 1/8 (12.5%) 1/18 (5.6%) 1/17 (5.9%)
Tinea Pedis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Tooth Abscess 0/161 (0%) 1/163 (0.6%) 2/179 (1.1%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Upper Respiratory Tract Infection 7/161 (4.3%) 3/163 (1.8%) 9/179 (5%) 4/75 (5.3%) 4/97 (4.1%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Vulvovaginal Mycotic Infection 2/161 (1.2%) 2/163 (1.2%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Injury, poisoning and procedural complications
Arthropod Bite 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Epicondylitis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Face Injury 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Ligament Rupture 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Investigations
Alanine Aminotransferase Increased 3/161 (1.9%) 8/163 (4.9%) 6/179 (3.4%) 0/75 (0%) 0/97 (0%) 2/108 (1.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Aspartate Aminotransferase Increased 2/161 (1.2%) 6/163 (3.7%) 6/179 (3.4%) 1/75 (1.3%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Blood Albumin Abnormal 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Blood Alkaline Phosphatase Increased 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
C-Reactive Protein Abnormal 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
C-Reactive Protein Increased 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Hepatic Enzyme Increased 2/161 (1.2%) 1/163 (0.6%) 3/179 (1.7%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Liver Function Test Abnormal 3/161 (1.9%) 1/163 (0.6%) 2/179 (1.1%) 0/75 (0%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Weight Increased 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 14/161 (8.7%) 23/163 (14.1%) 17/179 (9.5%) 7/75 (9.3%) 10/97 (10.3%) 5/108 (4.6%) 3/8 (37.5%) 5/18 (27.8%) 2/17 (11.8%)
Back Pain 7/161 (4.3%) 6/163 (3.7%) 5/179 (2.8%) 2/75 (2.7%) 5/97 (5.2%) 4/108 (3.7%) 2/8 (25%) 0/18 (0%) 1/17 (5.9%)
Lupus-Like Syndrome 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Muscle Rigidity 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Musculoskeletal Stiffness 0/161 (0%) 1/163 (0.6%) 3/179 (1.7%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 1/18 (5.6%) 0/17 (0%)
Myalgia 6/161 (3.7%) 8/163 (4.9%) 2/179 (1.1%) 0/75 (0%) 2/97 (2.1%) 0/108 (0%) 0/8 (0%) 2/18 (11.1%) 0/17 (0%)
Neck Pain 1/161 (0.6%) 2/163 (1.2%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Osteopenia 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Pain in Extremity 2/161 (1.2%) 5/163 (3.1%) 2/179 (1.1%) 1/75 (1.3%) 0/97 (0%) 2/108 (1.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Plantar Fasciitis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Spondyloarthropathy 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm of Skin 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Nervous system disorders
Dizziness 6/161 (3.7%) 11/163 (6.7%) 10/179 (5.6%) 1/75 (1.3%) 2/97 (2.1%) 0/108 (0%) 1/8 (12.5%) 2/18 (11.1%) 0/17 (0%)
Headache 19/161 (11.8%) 22/163 (13.5%) 22/179 (12.3%) 4/75 (5.3%) 9/97 (9.3%) 4/108 (3.7%) 2/8 (25%) 2/18 (11.1%) 1/17 (5.9%)
Hypoaesthesia 3/161 (1.9%) 4/163 (2.5%) 0/179 (0%) 0/75 (0%) 2/97 (2.1%) 1/108 (0.9%) 0/8 (0%) 2/18 (11.1%) 0/17 (0%)
Lethargy 0/161 (0%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Syncope Vasovagal 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy 0/161 (0%) 0/163 (0%) 2/179 (1.1%) 0/75 (0%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 0/18 (0%) 2/17 (11.8%)
Psychiatric disorders
Anxiety 1/161 (0.6%) 3/163 (1.8%) 2/179 (1.1%) 0/75 (0%) 1/97 (1%) 1/108 (0.9%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Depressed Mood 0/161 (0%) 1/163 (0.6%) 1/179 (0.6%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Depression 4/161 (2.5%) 5/163 (3.1%) 1/179 (0.6%) 0/75 (0%) 2/97 (2.1%) 2/108 (1.9%) 0/8 (0%) 1/18 (5.6%) 1/17 (5.9%)
Fear 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Insomnia 5/161 (3.1%) 4/163 (2.5%) 1/179 (0.6%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 1/8 (12.5%) 1/18 (5.6%) 0/17 (0%)
Sleep Disorder 0/161 (0%) 2/163 (1.2%) 2/179 (1.1%) 0/75 (0%) 1/97 (1%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 1/17 (5.9%)
Renal and urinary disorders
Dysuria 4/161 (2.5%) 0/163 (0%) 1/179 (0.6%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Reproductive system and breast disorders
Endometriosis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 2/108 (1.9%) 0/8 (0%) 0/18 (0%) 2/17 (11.8%)
Chronic Obstructive Pulmonary Disease 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Cough 7/161 (4.3%) 11/163 (6.7%) 2/179 (1.1%) 4/75 (5.3%) 1/97 (1%) 3/108 (2.8%) 0/8 (0%) 3/18 (16.7%) 3/17 (17.6%)
Dysphonia 0/161 (0%) 1/163 (0.6%) 1/179 (0.6%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Dyspnoea 2/161 (1.2%) 3/163 (1.8%) 5/179 (2.8%) 1/75 (1.3%) 1/97 (1%) 1/108 (0.9%) 0/8 (0%) 1/18 (5.6%) 1/17 (5.9%)
Oropharyngeal Pain 5/161 (3.1%) 12/163 (7.4%) 5/179 (2.8%) 1/75 (1.3%) 2/97 (2.1%) 3/108 (2.8%) 2/8 (25%) 1/18 (5.6%) 2/17 (11.8%)
Productive Cough 2/161 (1.2%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Sinus Disorder 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 0/18 (0%) 0/17 (0%)
Skin and subcutaneous tissue disorders
Acne 3/161 (1.9%) 3/163 (1.8%) 4/179 (2.2%) 0/75 (0%) 0/97 (0%) 3/108 (2.8%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Alopecia 4/161 (2.5%) 7/163 (4.3%) 7/179 (3.9%) 1/75 (1.3%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Dry Skin 1/161 (0.6%) 2/163 (1.2%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 2/18 (11.1%) 1/17 (5.9%)
Eczema 0/161 (0%) 1/163 (0.6%) 4/179 (2.2%) 1/75 (1.3%) 3/97 (3.1%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Erythema 1/161 (0.6%) 0/163 (0%) 2/179 (1.1%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Exfoliative Rash 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Night Sweats 4/161 (2.5%) 1/163 (0.6%) 2/179 (1.1%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Pain of Skin 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Photosensitivity Reaction 1/161 (0.6%) 1/163 (0.6%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 0/108 (0%) 1/8 (12.5%) 1/18 (5.6%) 0/17 (0%)
Pityriasis 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Pruritus 5/161 (3.1%) 2/163 (1.2%) 3/179 (1.7%) 1/75 (1.3%) 1/97 (1%) 0/108 (0%) 1/8 (12.5%) 1/18 (5.6%) 1/17 (5.9%)
Rash 9/161 (5.6%) 7/163 (4.3%) 9/179 (5%) 0/75 (0%) 1/97 (1%) 2/108 (1.9%) 1/8 (12.5%) 1/18 (5.6%) 0/17 (0%)
Seborrhoeic Dermatitis 0/161 (0%) 0/163 (0%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Social circumstances
Pregnancy of Partner 1/161 (0.6%) 0/163 (0%) 0/179 (0%) 1/75 (1.3%) 0/97 (0%) 2/108 (1.9%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Surgical and medical procedures
Tooth Extraction 0/161 (0%) 0/163 (0%) 1/179 (0.6%) 0/75 (0%) 0/97 (0%) 1/108 (0.9%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)
Vascular disorders
Haematoma 0/161 (0%) 1/163 (0.6%) 0/179 (0%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 0/18 (0%) 1/17 (5.9%)
Hypertension 3/161 (1.9%) 5/163 (3.1%) 3/179 (1.7%) 0/75 (0%) 0/97 (0%) 0/108 (0%) 0/8 (0%) 1/18 (5.6%) 0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Study Director
Organization Centocor Ortho Biotech Services, L.L.C.
Phone 215 325-7405
Email
Responsible Party:
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00094458
Other Study ID Numbers:
  • CR004804
  • C0168T67
First Posted:
Oct 20, 2004
Last Update Posted:
Feb 9, 2017
Last Verified:
Dec 1, 2016