Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis
Brief summary
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. 1. Unknown adverse reactions (in particular, clinically significant) 2. Incidence and conditions of occurrence of adverse reactions in clinical practice 3. Factors likely to affect the safety and effectiveness
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients receiving Humira for the first time for the treatment of Ulcerative Colitis
Exclusion criteria
Contraindications according to the Package Insert include patients who have any of the following: * serious infections * tuberculosis * a history of hypersensitivity to any ingredient of Humira * demyelinating disease or a history of demyelinating disease * congestive cardiac failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Up to Week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52) | 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. |
| Mayo Endoscopic Sub-Score Over Time | Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52) | 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). |
| Change From Baseline in Partial Mayo Score Over Time | Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52) | 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,593 |
| Total | 1,593 |
Baseline characteristics
| Characteristic | Humira |
|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 16.1 |
| C-Reactive Protein (CRP) | 1.20 mg/dL STANDARD_DEVIATION 2.35 |
| Endoscopy Results Mild | 11 Participants |
| Endoscopy Results Moderate | 104 Participants |
| Endoscopy Results Normal or Remission-Phase Mucosa | 3 Participants |
| Endoscopy Results Severe | 61 Participants |
| Mayo Score | 7.5 score on a scale STANDARD_DEVIATION 2.3 |
| Partial Mayo Score | 5.1 score on a scale STANDARD_DEVIATION 2.1 |
| Race/Ethnicity, Customized Japanese | 1568 Participants |
| Race/Ethnicity, Customized Other Asians | 11 Participants |
| Race/Ethnicity, Customized Other (Not Specified) | 14 Participants |
| Sex: Female, Male Female | 680 Participants |
| Sex: Female, Male Male | 913 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 1,523 |
| other Total, other adverse events | 0 / 1,523 |
| serious Total, serious adverse events | 74 / 1,523 |
Outcome results
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.
Time frame: Up to Week 52
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Humira | Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Adverse Drug Reactions | 276 Participants |
| Humira | Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Serious Adverse Drug Reactions | 74 Participants |
Secondary
Change From Baseline in CRP Levels Over Time
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Humira | Change From Baseline in CRP Levels Over Time | Week 4 | 0.64 mg/dL | Standard Deviation 1.65 |
| Humira | Change From Baseline in CRP Levels Over Time | Week 8 | 0.53 mg/dL | Standard Deviation 1.34 |
| Humira | Change From Baseline in CRP Levels Over Time | Week 24 | 0.38 mg/dL | Standard Deviation 1 |
| Humira | Change From Baseline in CRP Levels Over Time | Week 52 | 0.29 mg/dL | Standard Deviation 0.89 |
| Humira | Change From Baseline in CRP Levels Over Time | At Discontinuation | 2.10 mg/dL | Standard Deviation 3.68 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Humira | Change From Baseline in Mayo Score Over Time | When Discontinued | 0.8 score on a scale | Standard Deviation 3.5 |
| Humira | Change From Baseline in Mayo Score Over Time | Week 24 | -4.4 score on a scale | Standard Deviation 3.1 |
| Humira | Change From Baseline in Mayo Score Over Time | Week 52 | -4.8 score on a scale | Standard Deviation 3.1 |
| Humira | Change From Baseline in Mayo Score Over Time | At Final Assessment | -3.3 score on a scale | Standard Deviation 4 |
Comparison: Change from Baseline at Week 24p-value: <0.0001paired t-test
Comparison: Change from Baseline at Week 52p-value: <0.0001paired t-test
Comparison: Change from Baseline When Discontinuedp-value: 0.5512paired t-test
Comparison: Change from Baseline at Final Assessmentp-value: <0.0001paired t-test
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Humira | Change From Baseline in Partial Mayo Score Over Time | Week 4 | -2.1 score on a scale | Standard Deviation 2.4 |
| Humira | Change From Baseline in Partial Mayo Score Over Time | Week 8 | -2.5 score on a scale | Standard Deviation 2.6 |
| Humira | Change From Baseline in Partial Mayo Score Over Time | Week 16 | -2.8 score on a scale | Standard Deviation 2.6 |
| Humira | Change From Baseline in Partial Mayo Score Over Time | Week 24 | -3.0 score on a scale | Standard Deviation 2.6 |
| Humira | Change From Baseline in Partial Mayo Score Over Time | Week 52 | -3.5 score on a scale | Standard Deviation 2.6 |
| Humira | Change From Baseline in Partial Mayo Score Over Time | When Discontinued | -0.7 score on a scale | Standard Deviation 2.7 |
| Humira | Change From Baseline in Partial Mayo Score Over Time | At Final Assessment | -2.5 score on a scale | Standard Deviation 3 |
Comparison: Change from Baseline at Week 4p-value: <0.0001paired t-test
Comparison: Change from Baseline at Week 8p-value: <0.0001paired t-test
Comparison: Change from Baseline at Week 16p-value: <0.0001paired t-test
Comparison: Change from Baseline at Week 24p-value: <0.0001paired t-test
Comparison: Change from Baseline at Week 52p-value: <0.0001paired t-test
Comparison: Change from Baseline when discontinuedp-value: <0.0001paired t-test
Comparison: Change from Baseline at Final Assessmentp-value: <0.0001paired t-test
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).
Time frame: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Humira | Mayo Endoscopic Sub-Score Over Time | Week 24 | 0=Normal or Inactive Disease | 18 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | Week 24 | 1=Mild Disease | 21 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | Week 24 | 2=Moderate Disease | 16 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | Week 24 | 3=Severe Disease | 6 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | Week 52 | 0=Normal or Inactive Disease | 35 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | Week 52 | 1=Mild Disease | 34 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | Week 52 | 2=Moderate Disease | 29 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | Week 52 | 3=Severe Disease | 4 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | When Discontinued | 0=Normal or Inactive Disease | 2 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | When Discontinued | 1=Mild Disease | 5 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | When Discontinued | 2=Moderate Disease | 21 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | When Discontinued | 3=Severe Disease | 18 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | At Final Assessment | 0=Normal or Inactive Disease | 47 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | At Final Assessment | 1=Mild Disease | 49 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | At Final Assessment | 2=Moderate Disease | 58 Participants |
| Humira | Mayo Endoscopic Sub-Score Over Time | At Final Assessment | 3=Severe Disease | 25 Participants |