Trial Outcomes & Findings for Special Investigation in Patients With Ulcerative Colitis (NCT NCT01947816)
NCT ID: NCT01947816
Last Updated: 2019-05-13
Results Overview
Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.
Recruitment status
COMPLETED
Target enrollment
1621 participants
Primary outcome timeframe
Up to Week 52
Results posted on
2019-05-13
Participant Flow
A total of 1621 participants were enrolled. Among the enrolled participants, case report forms were not collected from 28 participants, and there were 1593 participants whose data in case report forms were assessable.
Participant milestones
| Measure |
Humira
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
1593
|
|
Overall Study
COMPLETED
|
1523
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
participants with an assessment at the time of study drug administration start
Baseline characteristics by cohort
| Measure |
Humira
n=1593 Participants
Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
|
|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 16.1 • n=1593 Participants
|
|
Sex: Female, Male
Female
|
680 Participants
n=1593 Participants
|
|
Sex: Female, Male
Male
|
913 Participants
n=1593 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
1568 Participants
n=1593 Participants
|
|
Race/Ethnicity, Customized
Other Asians
|
11 Participants
n=1593 Participants
|
|
Race/Ethnicity, Customized
Other (Not Specified)
|
14 Participants
n=1593 Participants
|
|
C-Reactive Protein (CRP)
|
1.20 mg/dL
STANDARD_DEVIATION 2.35 • n=1058 Participants • participants with an assessment at the time of study drug administration start
|
|
Mayo Score
|
7.5 score on a scale
STANDARD_DEVIATION 2.3 • n=168 Participants • participants with an assessment at the time of study drug administration start
|
|
Endoscopy Results
Normal or Remission-Phase Mucosa
|
3 Participants
n=179 Participants • participants with an assessment at the time of study drug administration start
|
|
Endoscopy Results
Mild
|
11 Participants
n=179 Participants • participants with an assessment at the time of study drug administration start
|
|
Endoscopy Results
Moderate
|
104 Participants
n=179 Participants • participants with an assessment at the time of study drug administration start
|
|
Endoscopy Results
Severe
|
61 Participants
n=179 Participants • participants with an assessment at the time of study drug administration start
|
|
Partial Mayo Score
|
5.1 score on a scale
STANDARD_DEVIATION 2.1 • n=1186 Participants • participants with an assessment at the time of study drug administration start
|
PRIMARY outcome
Timeframe: Up to Week 52Population: Safety Analysis Set
Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.
Outcome measures
| Measure |
Humira
n=1523 Participants
Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
Adverse Drug Reactions
|
276 Participants
|
|
Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
Serious Adverse Drug Reactions
|
74 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52)Population: Participants with an assessment at given time point
Outcome measures
| Measure |
Humira
n=882 Participants
Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
|
|---|---|
|
Change From Baseline in CRP Levels Over Time
Week 4
|
0.64 mg/dL
Standard Deviation 1.65
|
|
Change From Baseline in CRP Levels Over Time
Week 8
|
0.53 mg/dL
Standard Deviation 1.34
|
|
Change From Baseline in CRP Levels Over Time
Week 24
|
0.38 mg/dL
Standard Deviation 1.00
|
|
Change From Baseline in CRP Levels Over Time
Week 52
|
0.29 mg/dL
Standard Deviation 0.89
|
|
Change From Baseline in CRP Levels Over Time
At Discontinuation
|
2.10 mg/dL
Standard Deviation 3.68
|
SECONDARY outcome
Timeframe: Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)Population: participants with an assessment at given time point
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Outcome measures
| Measure |
Humira
n=168 Participants
Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
|
|---|---|
|
Change From Baseline in Mayo Score Over Time
Week 24
|
-4.4 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in Mayo Score Over Time
Week 52
|
-4.8 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in Mayo Score Over Time
When Discontinued
|
0.8 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Mayo Score Over Time
At Final Assessment
|
-3.3 score on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)Population: participants with an assessment at given time point
The endoscopist evaluated each observed segment of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) by using the classification as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Humira
n=179 Participants
Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
|
|---|---|
|
Mayo Endoscopic Sub-Score Over Time
Week 24 · 0=Normal or Inactive Disease
|
18 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
Week 24 · 1=Mild Disease
|
21 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
Week 24 · 2=Moderate Disease
|
16 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
Week 24 · 3=Severe Disease
|
6 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
Week 52 · 0=Normal or Inactive Disease
|
35 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
Week 52 · 1=Mild Disease
|
34 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
Week 52 · 2=Moderate Disease
|
29 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
Week 52 · 3=Severe Disease
|
4 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
When Discontinued · 0=Normal or Inactive Disease
|
2 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
When Discontinued · 1=Mild Disease
|
5 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
When Discontinued · 2=Moderate Disease
|
21 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
When Discontinued · 3=Severe Disease
|
18 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
At Final Assessment · 0=Normal or Inactive Disease
|
47 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
At Final Assessment · 1=Mild Disease
|
49 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
At Final Assessment · 2=Moderate Disease
|
58 Participants
|
|
Mayo Endoscopic Sub-Score Over Time
At Final Assessment · 3=Severe Disease
|
25 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)Population: participants with an assessment at given time point
The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.
Outcome measures
| Measure |
Humira
n=1186 Participants
Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
|
|---|---|
|
Change From Baseline in Partial Mayo Score Over Time
Week 4
|
-2.1 score on a scale
Standard Deviation 2.4
|
|
Change From Baseline in Partial Mayo Score Over Time
Week 8
|
-2.5 score on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Partial Mayo Score Over Time
Week 16
|
-2.8 score on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Partial Mayo Score Over Time
Week 24
|
-3.0 score on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Partial Mayo Score Over Time
Week 52
|
-3.5 score on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Partial Mayo Score Over Time
When Discontinued
|
-0.7 score on a scale
Standard Deviation 2.7
|
|
Change From Baseline in Partial Mayo Score Over Time
At Final Assessment
|
-2.5 score on a scale
Standard Deviation 3.0
|
Adverse Events
Humira
Serious events: 74 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Humira
n=1523 participants at risk
Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.
|
|---|---|
|
Infections and infestations
Cellulitis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Clostridium difficile colitis
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Infections and infestations
Cytomegaloviral infections
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Disseminated tuberculosis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Endotoxic shock
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Escherichia sepsis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Gastroenteritis staphylococcal
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Herpes zoster
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Liver abscess
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Infections and infestations
Peritonitis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Pneumonia
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Infections and infestations
Pneumonia influenzal
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Pneumonia legionella
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Infections and infestations
Pyelonephritis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Sepsis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Varicella
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Cytomegalovirus enterocolitis
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Infections and infestations
Escherichia bacteraemia
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Staphylococcal sepsis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Infective thrombosis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Enteritis infectious
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Abdominal abscess
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Infective spondylitis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Device related infection
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Cytomegalovirus mucocutaneous ulcer
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Infections and infestations
Aspergillus infection
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage IV
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage I
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIB
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage II
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Blood and lymphatic system disorders
Dermatopathic lymphadenopathy
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Immune system disorders
Sarcoidosis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Psychiatric disorders
Depression
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Nervous system disorders
Headache
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Cardiac disorders
Atrial fibrillation
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Cardiac disorders
Right ventricular failure
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Vascular disorders
Aortic dissection
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Vascular disorders
Takayasu's arteritis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Vascular disorders
Thrombophlebitis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.39%
6/1523 • Number of events 6 • up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.2%
18/1523 • Number of events 18 • up to Week 52
|
|
Gastrointestinal disorders
Diarrhoea
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Haematochezia
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Gastrointestinal disorders
Megacolon
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Pancreatitis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.33%
5/1523 • Number of events 5 • up to Week 52
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Reproductive system and breast disorders
Prostatitis
|
0.13%
2/1523 • Number of events 2 • up to Week 52
|
|
General disorders
Pyrexia
|
0.33%
5/1523 • Number of events 5 • up to Week 52
|
|
Investigations
C-reactive protein increased
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Investigations
Neutrophil count decreased
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Investigations
White blood cell count decreased
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Investigations
C-reactive protein abnormal
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Injury, poisoning and procedural complications
Fall
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.07%
1/1523 • Number of events 1 • up to Week 52
|
Other adverse events
Adverse event data not reported
Additional Information
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