Crohn's Disease
Conditions
Keywords
Routine clinical setting, Long-term efficacy and safety, Crohn's Disease, Humira®, Adalimumab
Brief summary
The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.
Detailed description
This study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with CD who resided in Germany. Visits were scheduled every 3 months for the first year and every 6 months thereafter. Participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.
Exclusion criteria
\- Hypersensitivity against the drug or one of the other ingredients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity. |
| Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease. |
| Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity. |
| Percentage of Participants With Adverse Events (Excluding Serious Adverse Events) | Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. For more details on adverse events please see the AE section below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores. The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. Scores \< 5 indicate remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease. Each HBI unit is equivalent to approximately 27 CDAI units. Higher scores indicate greater disease activity. |
| Compliance With the Self-injection Via the Humira®-PEN | Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Adalimumab will be self-administered by participants using Humira®-PEN. Analysis of compliance was not performed as outlined in the protocol. |
Participant flow
Recruitment details
A total of 4107 participants were enrolled: 1621 in the full analysis set (FAS) population were analyzed for efficacy; 4107 were analyzed for safety.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Crohn's Disease (CD) Participants with Crohn's Disease treated with adalimumab in routine clinical practice. | 4,107 |
| Total | 4,107 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2,758 |
| Overall Study | Withdrawal by Subject | 1,086 |
Baseline characteristics
| Characteristic | Participants With Crohn's Disease (CD) |
|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 2500 Participants |
| Sex: Female, Male Male | 1583 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4,107 |
| serious Total, serious adverse events | 548 / 4,107 |
Outcome results
Primary
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit
The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity.
Time frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Effectiveness analyses included all participants with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 3 | -117 units on a scale | Standard Deviation 117 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 6 | -124 units on a scale | Standard Deviation 127 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 9 | -131 units on a scale | Standard Deviation 122 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 12 | -137 units on a scale | Standard Deviation 125 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 18 | -142 units on a scale | Standard Deviation 126 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 24 | -137 units on a scale | Standard Deviation 135 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 30 | -145 units on a scale | Standard Deviation 119 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 36 | -149 units on a scale | Standard Deviation 118 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 42 | -151 units on a scale | Standard Deviation 113 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 48 | -153 units on a scale | Standard Deviation 109 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 54 | -156 units on a scale | Standard Deviation 113 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit | Month 60 | -138 units on a scale | Standard Deviation 119 |
Primary
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity.
Time frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Effectiveness analyses included all participants with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 3 | 10.8 units on a scale | Standard Deviation 12.4 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 6 | 12.1 units on a scale | Standard Deviation 13.2 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 9 | 12.6 units on a scale | Standard Deviation 13.3 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 12 | 13.7 units on a scale | Standard Deviation 13.8 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 18 | 13.2 units on a scale | Standard Deviation 12.9 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 24 | 14.7 units on a scale | Standard Deviation 14.6 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 30 | 14.8 units on a scale | Standard Deviation 14.3 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 36 | 14.6 units on a scale | Standard Deviation 14.8 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 42 | 15.4 units on a scale | Standard Deviation 13.6 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 48 | 16.9 units on a scale | Standard Deviation 14.2 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 54 | 18.0 units on a scale | Standard Deviation 14.4 |
| Participants With Crohn's Disease (CD) | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants | Month 60 | 10.2 units on a scale | Standard Deviation 13.3 |
Primary
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time
The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease.
Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Effectiveness analyses included all participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 0 (Remission) | 12.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 0 (Mild disease) | 28.8 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 0 (Moderate disease) | 54.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 0 (Severe disease) | 4.8 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 3 (Remission) | 64.4 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 3 (Mild disease) | 17.4 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 3 (Moderate Disease) | 17.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 3 (Severe Disease) | 1.0 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 6 (Remission) | 67.0 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 6 (Mild Disease) | 15.3 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 6 (Moderate Disease) | 16.6 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 6 (Severe Disease) | 1.1 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 9 (Remission) | 66.7 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 9 (Mild Disease) | 18.8 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 9 (Moderate Disease) | 14.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 9 (Severe Disease) | 0.3 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 12 (Remission) | 69.8 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 12 (Mild Disease) | 16.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 12 (Moderate Disease) | 13.4 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 12 (Severe Disease) | 0.6 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 18 (Remission) | 72.8 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 18 (Mild disease) | 13.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 18 (Moderate Disease) | 13.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 18 (Severe Disease) | 0.8 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 24 (Remission) | 70.7 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 24 (Mild Disease) | 14.9 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 24 (Moderate Disease) | 12.9 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 24 (Severe Disease) | 1.5 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 30 (Remission) | 73.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 30 (Mild Disease) | 14.9 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 30 (Moderate Disease) | 11.7 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 30 (Severe Diease) | 0.3 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 36 (Remission) | 75.4 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 36 (Mild Disease) | 11.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 36 (Moderate Disease) | 13.0 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 36 (Severe Disease) | 0.4 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 42 (Remission) | 74.5 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 42 (Mild Disease) | 12.3 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 42 (Moderate Disease) | 13.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 42 (Severe Disease) | 0.0 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 48 (Remission) | 72.7 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 48 (Mild Disease) | 16.1 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 48 (Moderate Disease) | 10.6 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 48 (Severe Disease) | 0.6 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 54 (Remission) | 76.3 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 54 (Mild Disease) | 12.3 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 54 (Moderate Disease) | 11.4 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 54 (Severe Disease) | 0.0 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 60 (Remission) | 68.4 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 60 (Mild Disease) | 15.2 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 60 (Moderate Disease) | 16.5 percentage of participants |
| Participants With Crohn's Disease (CD) | Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time | Month 60 (Severe Disease) | 0.0 percentage of participants |
Primary
Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. For more details on adverse events please see the AE section below.
Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Analysis included safety analysis population with incidence of greater than 1% during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Crohn's Disease (CD) | Percentage of Participants With Adverse Events (Excluding Serious Adverse Events) | 16.7 percentage of participants |
Secondary
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time
The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores. The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. Scores \< 5 indicate remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease. Each HBI unit is equivalent to approximately 27 CDAI units. Higher scores indicate greater disease activity.
Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Effectiveness analyses included all participants with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 0 | 9.3 units on a scale | Standard Deviation 4.6 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 3 | 4.8 units on a scale | Standard Deviation 4.5 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 6 | 4.5 units on a scale | Standard Deviation 4.6 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 9 | 4.2 units on a scale | Standard Deviation 4.2 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 12 | 4.1 units on a scale | Standard Deviation 4.2 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 18 | 3.9 units on a scale | Standard Deviation 4.1 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 24 | 4.1 units on a scale | Standard Deviation 4.7 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 30 | 3.5 units on a scale | Standard Deviation 3.9 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 36 | 3.6 units on a scale | Standard Deviation 4 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 42 | 3.9 units on a scale | Standard Deviation 3.9 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 48 | 3.4 units on a scale | Standard Deviation 3.5 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 54 | 3.3 units on a scale | Standard Deviation 3.6 |
| Participants With Crohn's Disease (CD) | 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time | Month 60 | 4.0 units on a scale | Standard Deviation 3.9 |
Secondary
Compliance With the Self-injection Via the Humira®-PEN
Adalimumab will be self-administered by participants using Humira®-PEN. Analysis of compliance was not performed as outlined in the protocol.
Time frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Compliance data were not collected.