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This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humira | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | 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. | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CRP Levels Over Time | Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52) | |
| Change From Baseline in Mayo Score Over Time | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications according to the Package Insert include patients who have any of the following:
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Patients for the first time receiving Humira for the treatment of Ulcerative Colitis
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Humira | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | 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. | Safety Analysis Set | Posted | Count of Participants | Participants | Up to Week 52 |
|
|
up to Week 52
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Humira | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2018 | Dec 19, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 1, 2018 | May 10, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52) |
| Mayo Endoscopic Sub-Score Over Time | 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). | Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52) |
| Change From Baseline in Partial Mayo Score Over Time | 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. | Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| C-Reactive Protein (CRP) | participants with an assessment at the time of study drug administration start | Mean | Standard Deviation | mg/dL |
|
| Mayo Score | 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). | participants with an assessment at the time of study drug administration start | Mean | Standard Deviation | score on a scale |
|
| Endoscopy Results | 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). | participants with an assessment at the time of study drug administration start | Count of Participants | Participants |
|
| Partial Mayo Score | 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). | participants with an assessment at the time of study drug administration start | Mean | Standard Deviation | score on a scale |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in CRP Levels Over Time | Participants with an assessment at given time point | Posted | Mean | Standard Deviation | mg/dL | Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52) |
|
|
|
| Secondary | Change From Baseline in Mayo Score Over Time | 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. | participants with an assessment at given time point | Posted | Mean | Standard Deviation | score on a scale | Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52) |
|
|
|
|
| Secondary | Mayo Endoscopic Sub-Score Over Time | 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). | participants with an assessment at given time point | Posted | Count of Participants | Participants | Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52) |
|
|
|
| Secondary | Change From Baseline in Partial Mayo Score Over Time | 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. | participants with an assessment at given time point | Posted | Mean | Standard Deviation | score on a scale | Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52) |
|
|
|
|
| 5 |
| 1,523 |
| 74 |
| 1,523 |
| 0 |
| 1,523 |
| Clostridium difficile colitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cytomegaloviral infections | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Endotoxic shock | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastroenteritis staphylococcal | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cytomegalovirus colitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infective thrombosis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infective spondylitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Cytomegalovirus mucocutaneous ulcer | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Aspergillus infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Breast cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Colon cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Non-small cell lung cancer stage IIIB | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Rectal cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Inflammatory pseudotumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Dermatopathic lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Takayasu's arteritis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Gastroenteritis eosinophilic | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Megacolon | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Autoimmune pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| C-reactive protein abnormal | Investigations | MedDRA 20.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
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.
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
|
| Week 24 |
|
|
| Week 52 |
|
|
| At Discontinuation |
|
|
|
| When Discontinued |
|
|
| At Final Assessment |
|
|
| < 0.0001 |
| Superiority |
| Change from Baseline When Discontinued | paired t-test | 0.5512 | Superiority |
| Change from Baseline at Final Assessment | paired t-test | < 0.0001 | Superiority |
| 2=Moderate Disease |
|
| 3=Severe Disease |
|
| Week 52 |
|
|
| When Discontinued |
|
|
| At Final Assessment |
|
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 52 |
|
|
| When Discontinued |
|
|
| At Final Assessment |
|
|
| < 0.0001 |
| Superiority |
| Change from Baseline at Week 16 | paired t-test | < 0.0001 | Superiority |
| Change from Baseline at Week 24 | paired t-test | < 0.0001 | Superiority |
| Change from Baseline at Week 52 | paired t-test | < 0.0001 | Superiority |
| Change from Baseline when discontinued | paired t-test | < 0.0001 | Superiority |
| Change from Baseline at Final Assessment | paired t-test | < 0.0001 | Superiority |