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Special Investigation in Patients With Crohn's Disease (All Patients Investigation)

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ClinicalTrials.gov Identifier: NCT01298648
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : March 18, 2014
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Crohn's Disease
Enrollment 1716
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Humira
Hide Arm/Group Description Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Period Title: Overall Study
Started 1716
Completed 1693
Not Completed 23
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             21
Arm/Group Title Humira
Hide Arm/Group Description Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Overall Number of Baseline Participants 1693
Hide Baseline Analysis Population Description
Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1693 participants
35.5  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1693 participants
Female
584
  34.5%
Male
1109
  65.5%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Overall Number of Participants Analyzed 1693
Measure Type: Number
Unit of Measure: participants
AEs 453
SAEs 147
ADRs 360
SADRs 96
2.Primary Outcome
Title Crohn's Disease Activity Index (CDAI) at Baseline and Week 4
Hide Description The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Time Frame Baseline, Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Overall Number of Participants Analyzed 1017
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n=1017) 204.3  (105.7)
Week 4 (n=912) 142.9  (90.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired t-test using observed cases at Baseline and Week 4.
3.Primary Outcome
Title Crohn's Disease Activity Index (CDAI) at Baseline and Week 8
Hide Description The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Overall Number of Participants Analyzed 1017
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n=1017) 204.3  (105.7)
Week 8 (n=818) 142.7  (93.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments Paired t-test using observed values at Baseline and Week 8.
4.Primary Outcome
Title Crohn's Disease Activity Index (CDAI) at Baseline and Week 24
Hide Description The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Overall Number of Participants Analyzed 1017
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n=1017) 204.3  (105.7)
Week 24 (n=982) 149.1  (100.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired t-test using observed values at Baseline and Week 24.
5.Secondary Outcome
Title Improvement Rating by Investigator at Week 24
Hide Description Overall response rating, according to investigator’s subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Humira
Hide Arm/Group Description:
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Overall Number of Participants Analyzed 1619
Measure Type: Number
Unit of Measure: percentage of participants
Percentage of Participants Markedly improved 20.6
Percentage of Participants Improved 55.3
Percentage of Participants Not Improved 17.2
Percentage of Participants Not Assessable 7.0
6.Secondary Outcome
Title Remission Rate at Week 4, Week 8, and Week 24
Hide Description The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.
Time Frame Baseline, Week 4, Week 8, and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at each time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Overall Number of Participants Analyzed 1017
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 (284/607) 46.8
Week 8 (260/542) 48.0
Week 24 (304/649) 46.8
Time Frame 24 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Humira
Hide Arm/Group Description Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
All-Cause Mortality
Humira
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Humira
Affected / at Risk (%)
Total   147/1693 (8.68%) 
Blood and lymphatic system disorders   
Anaemia * 1  2/1693 (0.12%) 
Disseminated intravascular coagulation * 1  2/1693 (0.12%) 
Pancytopenia * 1  2/1693 (0.12%) 
Cardiac disorders   
Bradycardia * 1  1/1693 (0.06%) 
Cardiac failure * 1  2/1693 (0.12%) 
Cardiovascular disorder * 1  1/1693 (0.06%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/1693 (0.12%) 
Anal stenosis * 1  1/1693 (0.06%) 
Anorectal disorder * 1  1/1693 (0.06%) 
Ascites * 1  1/1693 (0.06%) 
Crohn's disease * 1  13/1693 (0.77%) 
Diarrhoea * 1  1/1693 (0.06%) 
Frequent bowel movements * 1  1/1693 (0.06%) 
Gastrointestinal haemorrhage * 1  2/1693 (0.12%) 
Gastrointestinal stenosis * 1  1/1693 (0.06%) 
Haemorrhoids * 1  1/1693 (0.06%) 
IIleal stenosis * 1  1/1693 (0.06%) 
Ileus * 1  4/1693 (0.24%) 
Intestinal obstruction * 1  9/1693 (0.53%) 
Intestinal perforation * 1  1/1693 (0.06%) 
Intestinal stenosis * 1  5/1693 (0.30%) 
Large intestine perforation * 1  1/1693 (0.06%) 
Melaena * 1  4/1693 (0.24%) 
Pancreatitis acute * 1  1/1693 (0.06%) 
Rectal ulcer haemorrhage * 1  1/1693 (0.06%) 
Small intestinal perforation * 1  2/1693 (0.12%) 
Stomatitis * 1  1/1693 (0.06%) 
Subileus * 1  7/1693 (0.41%) 
Enterocutaneous fistula * 1  1/1693 (0.06%) 
Anorectal varices haemorrhage * 1  1/1693 (0.06%) 
General disorders   
Chest discomfort * 1  1/1693 (0.06%) 
Malaise * 1  1/1693 (0.06%) 
Multi-organ failure * 1  1/1693 (0.06%) 
Pyrexia * 1  4/1693 (0.24%) 
Sudden death * 1  1/1693 (0.06%) 
Hepatobiliary disorders   
Bile duct stone * 1  2/1693 (0.12%) 
Cholecystitis * 1  1/1693 (0.06%) 
Cholelithiasis * 1  2/1693 (0.12%) 
Hepatic cirrhosis * 1  1/1693 (0.06%) 
Hepatic failure * 1  1/1693 (0.06%) 
Hepatic function abnormal * 1  2/1693 (0.12%) 
Infections and infestations   
Abdominal wall abscess * 1  1/1693 (0.06%) 
Abscess intestinal * 1  1/1693 (0.06%) 
Bacteraemia * 1  1/1693 (0.06%) 
Cellulitis * 1  1/1693 (0.06%) 
Cholangitis suppurative * 1  1/1693 (0.06%) 
Clostridium difficile colitis * 1  1/1693 (0.06%) 
Hepatitis B * 1  1/1693 (0.06%) 
Herpes zoster * 1  3/1693 (0.18%) 
Pelvic abscess * 1  1/1693 (0.06%) 
Peritonitis * 1  2/1693 (0.12%) 
Pneumonia * 1  6/1693 (0.35%) 
Postoperative wound infection * 1  1/1693 (0.06%) 
Sepsis * 1  4/1693 (0.24%) 
Tonsillitis * 1  1/1693 (0.06%) 
Tuberculosis * 1  1/1693 (0.06%) 
Urinary tract infection * 1  1/1693 (0.06%) 
Vestibular neuronitis * 1  1/1693 (0.06%) 
Viral infection * 1  1/1693 (0.06%) 
Anal abscess * 1  7/1693 (0.41%) 
Salpingo-oophoritis * 1  1/1693 (0.06%) 
Intestinal fistula infection * 1  1/1693 (0.06%) 
Perirectal abscess * 1  1/1693 (0.06%) 
Staphylococcal sepsis * 1  1/1693 (0.06%) 
Lung infection pseudomonal * 1  1/1693 (0.06%) 
Enteritis infectious * 1  1/1693 (0.06%) 
Pseudomonal sepsis * 1  1/1693 (0.06%) 
Abdominal abscess * 1  4/1693 (0.24%) 
Pneumonia bacterial * 1  1/1693 (0.06%) 
Chlamydial infection * 1  1/1693 (0.06%) 
Clostridial infection * 1  1/1693 (0.06%) 
Enterocolitis viral * 1  1/1693 (0.06%) 
Herpes ophthalmic * 1  1/1693 (0.06%) 
Device related infection * 1  2/1693 (0.12%) 
Infectious peritonitis * 1  3/1693 (0.18%) 
Injury, poisoning and procedural complications   
Administration related reaction * 1  1/1693 (0.06%) 
Investigations   
Blood creatine phosphokinase increased * 1  2/1693 (0.12%) 
Blood pressure increased * 1  1/1693 (0.06%) 
Platelet count decreased * 1  1/1693 (0.06%) 
Red blood cell count decreased * 1  1/1693 (0.06%) 
Weight decreased * 1  1/1693 (0.06%) 
White blood cell count decreased * 1  1/1693 (0.06%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/1693 (0.06%) 
Hyperkalaemia * 1  1/1693 (0.06%) 
Hypoalbuminaemia * 1  2/1693 (0.12%) 
Hypocalcaemia * 1  2/1693 (0.12%) 
Hypokalaemia * 1  1/1693 (0.06%) 
Hypomagnesaemia * 1  1/1693 (0.06%) 
Malnutrition * 1  1/1693 (0.06%) 
Hyperamylasaemia * 1  1/1693 (0.06%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  1/1693 (0.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Gastric cancer * 1  1/1693 (0.06%) 
Neurilemmoma * 1  1/1693 (0.06%) 
Anal cancer * 1  3/1693 (0.18%) 
Leukaemia recurrent * 1  1/1693 (0.06%) 
Thyroid cancer * 1  1/1693 (0.06%) 
Nervous system disorders   
Cerebral haemorrhage * 1  1/1693 (0.06%) 
Cranial nerve palsies multiple * 1  1/1693 (0.06%) 
Headache * 1  1/1693 (0.06%) 
Mononeuropathy multiplex * 1  1/1693 (0.06%) 
Vasculitis cerebral * 1  1/1693 (0.06%) 
Lacunar infarction * 1  1/1693 (0.06%) 
Chronic inflammatory demyelinating polyradiculoneuropathy * 1  1/1693 (0.06%) 
Psychiatric disorders   
Depression * 1  1/1693 (0.06%) 
Panic disorder * 1  1/1693 (0.06%) 
Adjustment disorder * 1  1/1693 (0.06%) 
Renal and urinary disorders   
Nephrolithiasis * 1  1/1693 (0.06%) 
Renal haemorrhage * 1  1/1693 (0.06%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia aspiration * 1  1/1693 (0.06%) 
Pulmonary artery thrombosis * 1  1/1693 (0.06%) 
Respiratory failure * 1  1/1693 (0.06%) 
Skin and subcutaneous tissue disorders   
Eczema * 1  1/1693 (0.06%) 
Rash * 1  2/1693 (0.12%) 
Rash erythematous * 1  1/1693 (0.06%) 
Vascular disorders   
Jugular vein thrombosis * 1  1/1693 (0.06%) 
Vena cava thrombosis * 1  1/1693 (0.06%) 
Shock haemorrhagic * 1  1/1693 (0.06%) 
Deep vein thrombosis * 1  1/1693 (0.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Humira
Affected / at Risk (%)
Total   177/1693 (10.45%) 
Blood and lymphatic system disorders   
Anaemia * 1  8/1693 (0.47%) 
Gastrointestinal disorders   
Nausea * 1  9/1693 (0.53%) 
General disorders   
Injection site erythema * 1  11/1693 (0.65%) 
Injection site reactions * 1  24/1693 (1.42%) 
Malaise * 1  9/1693 (0.53%) 
Pyrexia * 1  22/1693 (1.30%) 
Hepatobiliary disorders   
Hepatic function abnormal * 1  9/1693 (0.53%) 
Liver disorder * 1  11/1693 (0.65%) 
Infections and infestations   
Bronchitis * 1  10/1693 (0.59%) 
Influenza * 1  8/1693 (0.47%) 
Nasopharyngitis * 1  30/1693 (1.77%) 
Pharyngitis * 1  13/1693 (0.77%) 
Nervous system disorders   
Headache * 1  9/1693 (0.53%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation * 1  13/1693 (0.77%) 
Skin and subcutaneous tissue disorders   
Rash * 1  24/1693 (1.42%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01298648     History of Changes
Other Study ID Numbers: P12-706
First Submitted: January 26, 2011
First Posted: February 18, 2011
Results First Submitted: January 31, 2014
Results First Posted: March 18, 2014
Last Update Posted: July 2, 2018