Trial Outcomes & Findings for Special Investigation in Patients With Crohn's Disease (All Patients Investigation) (NCT NCT01298648)
NCT ID: NCT01298648
Last Updated: 2018-07-02
Results Overview
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.
COMPLETED
1716 participants
24 weeks
2018-07-02
Participant Flow
Participant milestones
| Measure |
Humira
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Overall Study
STARTED
|
1716
|
|
Overall Study
COMPLETED
|
1693
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Humira
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
21
|
Baseline Characteristics
Special Investigation in Patients With Crohn's Disease (All Patients Investigation)
Baseline characteristics by cohort
| Measure |
Humira
n=1693 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
584 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1109 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Humira
n=1693 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
AEs
|
453 participants
|
|
Number of Participants With Adverse Events (AEs)
SAEs
|
147 participants
|
|
Number of Participants With Adverse Events (AEs)
ADRs
|
360 participants
|
|
Number of Participants With Adverse Events (AEs)
SADRs
|
96 participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Participants with available data at each time point.
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.
Outcome measures
| Measure |
Humira
n=1017 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Crohn's Disease Activity Index (CDAI) at Baseline and Week 4
Baseline (n=1017)
|
204.3 scores on a scale
Standard Deviation 105.7
|
|
Crohn's Disease Activity Index (CDAI) at Baseline and Week 4
Week 4 (n=912)
|
142.9 scores on a scale
Standard Deviation 90.4
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Participants with available data at each time point.
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.
Outcome measures
| Measure |
Humira
n=1017 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Crohn's Disease Activity Index (CDAI) at Baseline and Week 8
Baseline (n=1017)
|
204.3 scores on a scale
Standard Deviation 105.7
|
|
Crohn's Disease Activity Index (CDAI) at Baseline and Week 8
Week 8 (n=818)
|
142.7 scores on a scale
Standard Deviation 93.8
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Participants with available data at each time point.
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.
Outcome measures
| Measure |
Humira
n=1017 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Crohn's Disease Activity Index (CDAI) at Baseline and Week 24
Baseline (n=1017)
|
204.3 scores on a scale
Standard Deviation 105.7
|
|
Crohn's Disease Activity Index (CDAI) at Baseline and Week 24
Week 24 (n=982)
|
149.1 scores on a scale
Standard Deviation 100.9
|
SECONDARY outcome
Timeframe: Week 24Overall 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.
Outcome measures
| Measure |
Humira
n=1619 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Improvement Rating by Investigator at Week 24
Percentage of Participants Improved
|
55.3 percentage of participants
|
|
Improvement Rating by Investigator at Week 24
Percentage of Participants Not Improved
|
17.2 percentage of participants
|
|
Improvement Rating by Investigator at Week 24
Percentage of Participants Not Assessable
|
7.0 percentage of participants
|
|
Improvement Rating by Investigator at Week 24
Percentage of Participants Markedly improved
|
20.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, and Week 24Population: Participants with available data at each time point.
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.
Outcome measures
| Measure |
Humira
n=1017 Participants
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Remission Rate at Week 4, Week 8, and Week 24
Week 4 (284/607)
|
46.8 percentage of participants
|
|
Remission Rate at Week 4, Week 8, and Week 24
Week 8 (260/542)
|
48.0 percentage of participants
|
|
Remission Rate at Week 4, Week 8, and Week 24
Week 24 (304/649)
|
46.8 percentage of participants
|
Adverse Events
Humira
Serious adverse events
| Measure |
Humira
n=1693 participants at risk
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Infections and infestations
Abdominal wall abscess
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Abscess intestinal
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Bacteraemia
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Cellulitis
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Cholangitis suppurative
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Hepatitis B
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Herpes zoster
|
0.18%
3/1693 • 24 weeks.
|
|
Infections and infestations
Pelvic abscess
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Peritonitis
|
0.12%
2/1693 • 24 weeks.
|
|
Infections and infestations
Pneumonia
|
0.35%
6/1693 • 24 weeks.
|
|
Infections and infestations
Postoperative wound infection
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Sepsis
|
0.24%
4/1693 • 24 weeks.
|
|
Infections and infestations
Tonsillitis
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Tuberculosis
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Vestibular neuronitis
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Viral infection
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Anal abscess
|
0.41%
7/1693 • 24 weeks.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Intestinal fistula infection
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Perirectal abscess
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Enteritis infectious
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Abdominal abscess
|
0.24%
4/1693 • 24 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Chlamydial infection
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Clostridial infection
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Enterocolitis viral
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Herpes ophthalmic
|
0.06%
1/1693 • 24 weeks.
|
|
Infections and infestations
Device related infection
|
0.12%
2/1693 • 24 weeks.
|
|
Infections and infestations
Infectious peritonitis
|
0.18%
3/1693 • 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.06%
1/1693 • 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma
|
0.06%
1/1693 • 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.18%
3/1693 • 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.06%
1/1693 • 24 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.06%
1/1693 • 24 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.12%
2/1693 • 24 weeks.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.12%
2/1693 • 24 weeks.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.12%
2/1693 • 24 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1693 • 24 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.06%
1/1693 • 24 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.12%
2/1693 • 24 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.12%
2/1693 • 24 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.06%
1/1693 • 24 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.06%
1/1693 • 24 weeks.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.06%
1/1693 • 24 weeks.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.06%
1/1693 • 24 weeks.
|
|
Psychiatric disorders
Depression
|
0.06%
1/1693 • 24 weeks.
|
|
Psychiatric disorders
Panic disorder
|
0.06%
1/1693 • 24 weeks.
|
|
Psychiatric disorders
Adjustment disorder
|
0.06%
1/1693 • 24 weeks.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
1/1693 • 24 weeks.
|
|
Nervous system disorders
Cranial nerve palsies multiple
|
0.06%
1/1693 • 24 weeks.
|
|
Nervous system disorders
Headache
|
0.06%
1/1693 • 24 weeks.
|
|
Nervous system disorders
Mononeuropathy multiplex
|
0.06%
1/1693 • 24 weeks.
|
|
Nervous system disorders
Vasculitis cerebral
|
0.06%
1/1693 • 24 weeks.
|
|
Nervous system disorders
Lacunar infarction
|
0.06%
1/1693 • 24 weeks.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.06%
1/1693 • 24 weeks.
|
|
Cardiac disorders
Bradycardia
|
0.06%
1/1693 • 24 weeks.
|
|
Cardiac disorders
Cardiac failure
|
0.12%
2/1693 • 24 weeks.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.06%
1/1693 • 24 weeks.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.06%
1/1693 • 24 weeks.
|
|
Vascular disorders
Vena cava thrombosis
|
0.06%
1/1693 • 24 weeks.
|
|
Vascular disorders
Shock haemorrhagic
|
0.06%
1/1693 • 24 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
1/1693 • 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.06%
1/1693 • 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.06%
1/1693 • 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.12%
2/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Anal stenosis
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Ascites
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.77%
13/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.12%
2/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal stenosis
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
IIleal stenosis
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Ileus
|
0.24%
4/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.53%
9/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.30%
5/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Melaena
|
0.24%
4/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.12%
2/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Subileus
|
0.41%
7/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.06%
1/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Anorectal varices haemorrhage
|
0.06%
1/1693 • 24 weeks.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.12%
2/1693 • 24 weeks.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
1/1693 • 24 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
2/1693 • 24 weeks.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.06%
1/1693 • 24 weeks.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.06%
1/1693 • 24 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.12%
2/1693 • 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.06%
1/1693 • 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.12%
2/1693 • 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.06%
1/1693 • 24 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.06%
1/1693 • 24 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.06%
1/1693 • 24 weeks.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.06%
1/1693 • 24 weeks.
|
|
General disorders
Chest discomfort
|
0.06%
1/1693 • 24 weeks.
|
|
General disorders
Malaise
|
0.06%
1/1693 • 24 weeks.
|
|
General disorders
Multi-organ failure
|
0.06%
1/1693 • 24 weeks.
|
|
General disorders
Pyrexia
|
0.24%
4/1693 • 24 weeks.
|
|
General disorders
Sudden death
|
0.06%
1/1693 • 24 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.12%
2/1693 • 24 weeks.
|
|
Investigations
Blood pressure increased
|
0.06%
1/1693 • 24 weeks.
|
|
Investigations
Platelet count decreased
|
0.06%
1/1693 • 24 weeks.
|
|
Investigations
Red blood cell count decreased
|
0.06%
1/1693 • 24 weeks.
|
|
Investigations
Weight decreased
|
0.06%
1/1693 • 24 weeks.
|
|
Investigations
White blood cell count decreased
|
0.06%
1/1693 • 24 weeks.
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
0.06%
1/1693 • 24 weeks.
|
Other adverse events
| Measure |
Humira
n=1693 participants at risk
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.59%
10/1693 • 24 weeks.
|
|
Infections and infestations
Influenza
|
0.47%
8/1693 • 24 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
30/1693 • 24 weeks.
|
|
Infections and infestations
Pharyngitis
|
0.77%
13/1693 • 24 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.47%
8/1693 • 24 weeks.
|
|
Nervous system disorders
Headache
|
0.53%
9/1693 • 24 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.77%
13/1693 • 24 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.53%
9/1693 • 24 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.53%
9/1693 • 24 weeks.
|
|
Hepatobiliary disorders
Liver disorder
|
0.65%
11/1693 • 24 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
24/1693 • 24 weeks.
|
|
General disorders
Injection site erythema
|
0.65%
11/1693 • 24 weeks.
|
|
General disorders
Injection site reactions
|
1.4%
24/1693 • 24 weeks.
|
|
General disorders
Malaise
|
0.53%
9/1693 • 24 weeks.
|
|
General disorders
Pyrexia
|
1.3%
22/1693 • 24 weeks.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER