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A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01190839
Recruitment Status : Terminated (Study is terminated as per Sponsor's Decision.)
First Posted : August 30, 2010
Results First Posted : October 22, 2014
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Crohn's Disease
Interventions Biological: Infliximab
Drug: Placebo
Enrollment 297
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Infliximab 5 mg/kg
Hide Arm/Group Description Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200. Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Period Title: Overall Study
Started 150 147
Treated 148 143
Completed 0 0
Not Completed 150 147
Reason Not Completed
Adverse Event             32             41
Protocol Violation             2             2
Lost to Follow-up             7             1
Death             1             0
Trial stopped by Sponsor             71             68
Undefined             35             31
Randomized but not treated             2             4
Arm/Group Title Placebo Infliximab 5 mg/kg Total
Hide Arm/Group Description Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200. Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200. Total of all reporting groups
Overall Number of Baseline Participants 150 147 297
Hide Baseline Analysis Population Description
Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 147 participants 297 participants
35.4  (12.41) 37.1  (13.49) 36.3  (12.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 147 participants 297 participants
Female
69
  46.0%
70
  47.6%
139
  46.8%
Male
81
  54.0%
77
  52.4%
158
  53.2%
1.Primary Outcome
Title Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76
Hide Description CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD] before or at Week 76 were considered to have clinical recurrence.
Time Frame Baseline up to Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.
Arm/Group Title Placebo Infliximab 5 mg/kg
Hide Arm/Group Description:
Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Overall Number of Participants Analyzed 150 147
Measure Type: Number
Unit of Measure: percentage of participants
20.0 12.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Infliximab 5 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76
Hide Description Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.
Time Frame Baseline up to Week 76
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the participants who were randomly assigned one of the treatment.
Arm/Group Title Placebo Infliximab 5 mg/kg
Hide Arm/Group Description:
Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Overall Number of Participants Analyzed 150 147
Measure Type: Number
Unit of Measure: percentage of participants
60.0 30.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Infliximab 5 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104
Hide Description CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD]before or at Week 104 were considered to have clinical recurrence.
Time Frame Baseline up to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.
Arm/Group Title Placebo Infliximab 5 mg/kg
Hide Arm/Group Description:
Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Overall Number of Participants Analyzed 150 147
Measure Type: Number
Unit of Measure: percentage of participants
25.3 17.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Infliximab 5 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.
Method Cochran-Mantel-Haenszel chi-square test
Comments [Not Specified]
Time Frame Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively)
Adverse Event Reporting Description All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
 
Arm/Group Title Placebo Infliximab 5 mg/kg First Placebo Then Infliximab 5 mg/kg First Infliximab 5 mg/kg Then Infliximab 10 mg/kg
Hide Arm/Group Description Participants treated with placebo through the final visit or through a protocol defined dose increase. If a participant had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group. Participants treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a participants had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group. Participants had a protocol defined dose increase from Placebo to infliximab 5 mg/kg. Only safety results after start of infliximab were included in this group. Participants had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg. Only safety results after the dose increase were included in this group.
All-Cause Mortality
Placebo Infliximab 5 mg/kg First Placebo Then Infliximab 5 mg/kg First Infliximab 5 mg/kg Then Infliximab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Infliximab 5 mg/kg First Placebo Then Infliximab 5 mg/kg First Infliximab 5 mg/kg Then Infliximab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/146 (24.66%)   32/145 (22.07%)   5/27 (18.52%)   2/9 (22.22%) 
Blood and lymphatic system disorders         
Anaemia  1  3/146 (2.05%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Pancytopenia  1  0/146 (0.00%)  0/145 (0.00%)  1/27 (3.70%)  0/9 (0.00%) 
Cardiac disorders         
Acute Myocardial Infarction  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Arteriosclerosis Coronary Artery  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Atrial Flutter  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Coronary Artery Disease  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Acute Coronary Syndrome  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Congenital, familial and genetic disorders         
Hydrocele  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders         
Abdominal Adhesions  1  2/146 (1.37%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Abdominal Hernia  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Abdominal Pain  1  4/146 (2.74%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Abdominal Pain Upper  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Anal Fistula  1  2/146 (1.37%)  0/145 (0.00%)  1/27 (3.70%)  0/9 (0.00%) 
Crohn's Disease  1  5/146 (3.42%)  1/145 (0.69%)  0/27 (0.00%)  2/9 (22.22%) 
Diarrhoea  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Enteritis  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Ileal Stenosis  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Inguinal Hernia  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Intestinal Obstruction  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Intestinal Perforation  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Lower Gastrointestinal Haemorrhage  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Small Intestinal Obstruction  1  2/146 (1.37%)  3/145 (2.07%)  0/27 (0.00%)  1/9 (11.11%) 
Umbilical Hernia  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Ileus  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
General disorders         
Adverse Drug Reaction  1  0/146 (0.00%)  1/145 (0.69%)  0/21 (0.00%)  0/6 (0.00%) 
Malaise  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Hepatobiliary disorders         
Bile Duct Stone  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Biliary Colic  1  1/146 (0.68%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Cholecystitis  1  0/146 (0.00%)  1/145 (0.69%)  0/21 (0.00%)  0/6 (0.00%) 
Cholelithiasis  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Immune system disorders         
Anaphylactic Reaction  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Serum Sickness  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Drug Hypersensitivity  1  1/146 (0.68%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Infections and infestations         
Abdominal Abscess  1  2/146 (1.37%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Abdominal Wall Abscess  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Anal Abscess  1  1/146 (0.68%)  0/145 (0.00%)  1/27 (3.70%)  0/9 (0.00%) 
Cytomegalovirus Infection  1  2/146 (1.37%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Erysipelas  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Pilonidal Cyst  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Pneumonia  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Pneumonia Legionella  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Postoperative Wound Infection  1  1/146 (0.68%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Pyelonephritis  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Staphylococcal Sepsis  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Tuberculosis  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Urinary Tract Infection  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Viral Infection  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Gastroenteritis  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Gastroenteritis Viral  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Stoma Site Infection  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Injury, poisoning and procedural complications         
Anastomotic Leak  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Incisional Hernia  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Infusion Related Reaction  1  0/146 (0.00%)  3/145 (2.07%)  0/27 (0.00%)  0/9 (0.00%) 
Procedural Pain  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Road Traffic Accident  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Scar  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Anastomotic Stenosis  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Post Procedural Diarrhoea  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Rib Fracture  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Tendon Rupture  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Hyperglycaemia  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Hypokalaemia  1  0/146 (0.00%)  1/145 (0.69%)  0/21 (0.00%)  0/6 (0.00%) 
Tetany  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders         
Fistula  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Lupus-Like Syndrome  1  0/146 (0.00%)  0/145 (0.00%)  1/27 (3.70%)  0/9 (0.00%) 
Osteonecrosis  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Spinal Column Stenosis  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Arthralgia  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Osteoarthritis  1  0/146 (0.00%)  0/145 (0.00%)  1/27 (3.70%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Renal Cancer  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Thyroid Cancer  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Basal Cell Carcinoma  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Nervous system disorders         
Radiculitis  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion Spontaneous  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Foetal Death  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Renal and urinary disorders         
Calculus Ureteric  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Renal Colic  1  0/146 (0.00%)  2/145 (1.38%)  0/27 (0.00%)  0/9 (0.00%) 
Calculus Urinary  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Reproductive system and breast disorders         
Colpocele  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders         
Pleurisy  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  0/146 (0.00%)  0/145 (0.00%)  1/27 (3.70%)  0/9 (0.00%) 
Surgical and medical procedures         
Maxillofacial Operation  1  1/146 (0.68%)  0/145 (0.00%)  0/21 (0.00%)  0/6 (0.00%) 
Intestinal Resection  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Infliximab 5 mg/kg First Placebo Then Infliximab 5 mg/kg First Infliximab 5 mg/kg Then Infliximab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   122/146 (83.56%)   121/145 (83.45%)   18/27 (66.67%)   8/9 (88.89%) 
Blood and lymphatic system disorders         
Anaemia  1  10/146 (6.85%)  8/145 (5.52%)  0/27 (0.00%)  0/9 (0.00%) 
Ear and labyrinth disorders         
Ear Pain  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Gastrointestinal disorders         
Abdominal Pain  1  36/146 (24.66%)  25/145 (17.24%)  4/27 (14.81%)  2/9 (22.22%) 
Abdominal Symptom  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Crohn's Disease  1  13/146 (8.90%)  10/145 (6.90%)  6/27 (22.22%)  3/9 (33.33%) 
Diarrhoea  1  27/146 (18.49%)  24/145 (16.55%)  2/27 (7.41%)  1/9 (11.11%) 
Dyspepsia  1  5/146 (3.42%)  10/145 (6.90%)  1/27 (3.70%)  0/9 (0.00%) 
Flatulence  1  7/146 (4.79%)  3/145 (2.07%)  0/21 (0.00%)  1/6 (16.67%) 
Mouth Ulceration  1  1/146 (0.68%)  4/145 (2.76%)  0/27 (0.00%)  2/9 (22.22%) 
Nausea  1  16/146 (10.96%)  25/145 (17.24%)  0/27 (0.00%)  2/9 (22.22%) 
Toothache  1  5/146 (3.42%)  5/145 (3.45%)  1/27 (3.70%)  1/9 (11.11%) 
Vomiting  1  11/146 (7.53%)  14/145 (9.66%)  0/27 (0.00%)  2/9 (22.22%) 
Abdominal Distension  1  8/146 (5.48%)  8/145 (5.52%)  1/27 (3.70%)  2/9 (22.22%) 
Abdominal Pain Upper  1  8/146 (5.48%)  8/145 (5.52%)  0/27 (0.00%)  1/9 (11.11%) 
Anal Fistula  1  2/146 (1.37%)  1/145 (0.69%)  2/27 (7.41%)  1/9 (11.11%) 
Aphthous Stomatitis  1  2/146 (1.37%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Diarrhoea Haemorrhagic  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Frequent Bowel Movements  1  7/146 (4.79%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Gastrooesophageal Reflux Disease  1  5/146 (3.42%)  5/145 (3.45%)  1/27 (3.70%)  1/9 (11.11%) 
Haemorrhoids  1  7/146 (4.79%)  1/145 (0.69%)  1/27 (3.70%)  1/9 (11.11%) 
Ileal Ulcer  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Rectal Haemorrhage  1  1/146 (0.68%)  6/145 (4.14%)  1/27 (3.70%)  1/9 (11.11%) 
General disorders         
Asthenia  1  8/146 (5.48%)  5/145 (3.45%)  1/27 (3.70%)  1/9 (11.11%) 
Pyrexia  1  17/146 (11.64%)  22/145 (15.17%)  1/27 (3.70%)  3/9 (33.33%) 
Adverse Drug Reaction  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Fatigue  1  10/146 (6.85%)  8/145 (5.52%)  1/27 (3.70%)  0/9 (0.00%) 
Infusion Site Extravasation  1  1/146 (0.68%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Local Swelling  1  1/146 (0.68%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Immune system disorders         
Drug Hypersensitivity  1  1/146 (0.68%)  1/145 (0.69%)  2/27 (7.41%)  0/9 (0.00%) 
Infections and infestations         
Anal Abscess  1  4/146 (2.74%)  0/145 (0.00%)  2/27 (7.41%)  0/9 (0.00%) 
Bronchitis  1  10/146 (6.85%)  7/145 (4.83%)  1/27 (3.70%)  0/9 (0.00%) 
Influenza  1  15/146 (10.27%)  12/145 (8.28%)  0/27 (0.00%)  0/9 (0.00%) 
Nasopharyngitis  1  37/146 (25.34%)  37/145 (25.52%)  3/27 (11.11%)  1/9 (11.11%) 
Purulent Discharge  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Upper Respiratory Tract Infection  1  21/146 (14.38%)  21/145 (14.48%)  5/27 (18.52%)  3/9 (33.33%) 
Urinary Tract Infection  1  7/146 (4.79%)  4/145 (2.76%)  0/27 (0.00%)  2/9 (22.22%) 
Conjunctivitis  1  2/146 (1.37%)  3/145 (2.07%)  0/27 (0.00%)  1/9 (11.11%) 
Gastroenteritis  1  8/146 (5.48%)  5/145 (3.45%)  0/27 (0.00%)  0/9 (0.00%) 
Gastroenteritis Salmonella  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Herpes Zoster  1  2/146 (1.37%)  5/145 (3.45%)  1/27 (3.70%)  1/9 (11.11%) 
Infected Dermal Cyst  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Sinusitis  1  7/146 (4.79%)  9/145 (6.21%)  0/27 (0.00%)  1/9 (11.11%) 
Tooth Abscess  1  2/146 (1.37%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications         
Contusion  1  3/146 (2.05%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Facial Bones Fracture  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Infusion Related Reaction  1  3/146 (2.05%)  7/145 (4.83%)  2/27 (7.41%)  0/9 (0.00%) 
Joint Injury  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Lower Limb Fracture  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Pulmonary Contusion  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Post Procedural Diarrhoea  1  0/146 (0.00%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Investigations         
Body Temperature Increased  1  0/146 (0.00%)  1/145 (0.69%)  2/27 (7.41%)  0/9 (0.00%) 
Endoscopy Abnormal  1  0/146 (0.00%)  0/145 (0.00%)  0/21 (0.00%)  1/6 (16.67%) 
Faecal Calprotectin  1  0/146 (0.00%)  3/145 (2.07%)  0/27 (0.00%)  1/9 (11.11%) 
Blood Calcium Decreased  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Blood Iron Decreased  1  1/146 (0.68%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders         
Dehydration  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Hypokalaemia  1  4/146 (2.74%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  32/146 (21.92%)  26/145 (17.93%)  4/27 (14.81%)  3/9 (33.33%) 
Back Pain  1  9/146 (6.16%)  16/145 (11.03%)  1/27 (3.70%)  3/9 (33.33%) 
Musculoskeletal Pain  1  3/146 (2.05%)  4/145 (2.76%)  0/27 (0.00%)  1/9 (11.11%) 
Myalgia  1  3/146 (2.05%)  8/145 (5.52%)  0/27 (0.00%)  0/9 (0.00%) 
Osteoporosis  1  1/146 (0.68%)  0/145 (0.00%)  1/27 (3.70%)  1/9 (11.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Dysplastic Naevus  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Squamous Cell Carcinoma of Skin  1  0/146 (0.00%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Nervous system disorders         
Dizziness Postural  1  2/146 (1.37%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Headache  1  31/146 (21.23%)  29/145 (20.00%)  1/27 (3.70%)  0/9 (0.00%) 
Lethargy  1  2/146 (1.37%)  2/145 (1.38%)  0/27 (0.00%)  2/9 (22.22%) 
Hypoaesthesia  1  2/146 (1.37%)  3/145 (2.07%)  1/27 (3.70%)  1/9 (11.11%) 
Hypotonia  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Migraine  1  3/146 (2.05%)  6/145 (4.14%)  0/27 (0.00%)  1/9 (11.11%) 
Restless Legs Syndrome  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Syncope  1  2/146 (1.37%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Pregnancy, puerperium and perinatal conditions         
Pregnancy  1  3/146 (2.05%)  2/145 (1.38%)  0/27 (0.00%)  1/9 (11.11%) 
Psychiatric disorders         
Depression  1  4/146 (2.74%)  9/145 (6.21%)  0/27 (0.00%)  0/9 (0.00%) 
Insomnia  1  1/146 (0.68%)  7/145 (4.83%)  1/27 (3.70%)  2/9 (22.22%) 
Respiratory, thoracic and mediastinal disorders         
Atelectasis  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Bronchiectasis  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Cough  1  17/146 (11.64%)  14/145 (9.66%)  0/27 (0.00%)  0/9 (0.00%) 
Oropharyngeal Pain  1  10/146 (6.85%)  14/145 (9.66%)  0/27 (0.00%)  0/9 (0.00%) 
Pleural Effusion  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Respiratory Distress  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  5/146 (3.42%)  10/145 (6.90%)  2/27 (7.41%)  1/9 (11.11%) 
Rash  1  9/146 (6.16%)  8/145 (5.52%)  0/27 (0.00%)  2/9 (22.22%) 
Skin Fissures  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Urticaria  1  1/146 (0.68%)  4/145 (2.76%)  1/27 (3.70%)  1/9 (11.11%) 
Dermal Cyst  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Hidradenitis  1  1/146 (0.68%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Social circumstances         
Pregnancy of Partner  1  2/146 (1.37%)  2/145 (1.38%)  2/27 (7.41%)  0/9 (0.00%) 
Vascular disorders         
Flushing  1  0/146 (0.00%)  1/145 (0.69%)  0/27 (0.00%)  1/9 (11.11%) 
Hypertension  1  3/146 (2.05%)  8/145 (5.52%)  1/27 (3.70%)  0/9 (0.00%) 
Poor Venous Access  1  0/146 (0.00%)  0/145 (0.00%)  0/27 (0.00%)  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Strategic Lead Gastroenterology
Organization: Janssen Pharmaceuticals
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01190839    
Other Study ID Numbers: CR017080
REMICADECRD3001 ( Other Identifier: Janssen Biotech Inc. )
2010-018431-18 ( EudraCT Number )
PREVENT ( Other Identifier: Janssen Biotech Inc. )
First Submitted: August 12, 2010
First Posted: August 30, 2010
Results First Submitted: October 16, 2014
Results First Posted: October 22, 2014
Last Update Posted: February 4, 2016