An observational study in Crohn's Disease, sponsored by AbbVie (prior sponsor, Abbott). Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
The purpose of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 5,025 is above the median of 166 across 624 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 223 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Crohn's disease who have been prescribed adalimumab according to the local label.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Subjects should not be enrolled if they cannot be treated in accordance with the local product label.
Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. For more details on adverse events please see the AE section below.
Time frame: Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100\*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to CD + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" and at least one admission to hospital at given timepoint..
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" at given timepoint.
Time frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
A total of 6 participants less than 18 years of age were enrolled in the study. Participants were permitted to re-enroll after discontinuing the study. Of the 2811 participants who discontinued study, 339 re-enrolled in the study; 102 participants discontinued from the study after re-enrollment.
| Milestone | Adalimumab (Humira) Treatment |
|---|---|
| Started | 5025 |
| Discontinued | 2811 |
| Re-enrolled | 339 |
| Discontinued after re-enrollment | 102 |
| Completed | 2451 |
| Not completed | 2574 |
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. For more details on adverse events please see the AE section below.
| Participants | Adalimumab (Humira) Treatment |
|---|---|
| Any AE | 2392 |
| Any SAE | 1853 |
| AE Leading to Discontinuation of Study Drug | 596 |
| Any AE Leading to Death | 43 |
The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
| units on a scale | Adalimumab (Humira) Treatment |
|---|---|
| Change from Baseline to Month 12 (N=1712) | 4.98 ± 12.335 |
| Change from Baseline to Month 24 (N=1319) | 4.20 ± 13.397 |
| Change from Baseline to Month 36 (N=1712) | 5.01 ± 12.994 |
| Change from Baseline to Month 48 (N=969) | 5.51 ± 13.466 |
| Change from Baseline to Month 60 (N=837) | 5.45 ± 13.211 |
| Change from Baseline to Month 72 (N=748) | 5.41 ± 12.768 |
The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
| units on a scale | Adalimumab (Humira) Treatment |
|---|---|
| Change from Baseline to Month 12 (N=3335) | -1.63 ± 4.961 |
| Change from Baseline to Month 24 (N=2856) | -1.63 ± 5.108 |
| Change from Baseline to Month 36 (N=2629) | -1.84 ± 5.143 |
| Change from Baseline to Month 48 (N=2403) | -1.91 ± 5.169 |
| Change from Baseline to Month 60 (N=2162) | -2.00 ± 5.242 |
| Change from Baseline to Month 72 (N=1983) | -2.08 ± 5.602 |
Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100\*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
| percentage of work time missed | Adalimumab (Humira) Treatment |
|---|---|
| Change from Baseline to Month 12 (N=829) | -4.92 ± 26.881 |
| Change from Baseline to Month 24 (N=612) | -3.02 ± 26.607 |
| Change from Baseline to Month 36 (N=507) | -5.62 ± 29.649 |
| Change from Baseline to Month 48 (N=436) | -3.93 ± 31.884 |
| Change from Baseline to Month 60 (N=368) | -3.22 ± 29.622 |
| Change from Baseline to Month 72 (N=303) | -3.89 ± 26.865 |
Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100\*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
| percentage of impairment while working | Adalimumab (Humira) Treatment |
|---|---|
| Change from Baseline to Month 12 (N=914) | -8.00 ± 29.602 |
| Change from Baseline to Month 24 (N=697) | -7.04 ± 31.666 |
| Change from Baseline to Month 36 (N=577) | -9.84 ± 30.570 |
| Change from Baseline to Month 48 (N=493) | -8.09 ± 33.611 |
| Change from Baseline to Month 60 (N=418) | -8.21 ± 30.130 |
| Change from Baseline to Month 72 (N=361) | -8.03 ± 29.472 |
The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)\* \[number of hours worked / (number of hours of work missed due to CD + number of hours worked)\]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
| percentage of overall work impairment | Adalimumab (Humira) Treatment |
|---|---|
| Change from Baseline to Month 12 (N=821) | -9.48 ± 32.976 |
| Change from Baseline to Month 24 (N=605) | -7.95 ± 35.798 |
| Change from Baseline to Month 36 (N=498) | -11.78 ± 34.886 |
| Change from Baseline to Month 48 (N=435) | -9.15 ± 36.957 |
| Change from Baseline to Month 60 (N=365) | -8.14 ± 34.696 |
| Change from Baseline to Month 72 (N=300) | -9.33 ± 34.631 |
Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100\*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.
| percentage of activity impairment | Adalimumab (Humira) Treatment |
|---|---|
| Change from Baseline to Month 12 (N=1665) | -10.93 ± 30.548 |
| Change from Baseline to Month 24 (N=1286) | -9.75 ± 33.244 |
| Change from Baseline to Month 36 (N=1095) | -10.07 ± 32.705 |
| Change from Baseline to Month 48 (N=944) | -10.14 ± 33.063 |
| Change from Baseline to Month 60 (N=817) | -10.78 ± 31.787 |
| Change from Baseline to Month 72 (N=718) | -11.13 ± 29.533 |
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.
| number of visits at physician's office | Adalimumab (Humira) Treatment |
|---|---|
| Baseline (N=97) | 2.79 ± 2.947 |
| Month 12 (N=780) | 1.95 ± 2.039 |
| Month 24 (N=1042) | 2.19 ± 2.079 |
| Month 36 (N=1003) | 2.38 ± 3.242 |
| Month 48 (N=869) | 2.38 ± 2.326 |
| Month 60 (N=798) | 2.39 ± 2.084 |
| Month 72 (N=711) | 2.32 ± 2.051 |
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.
| number of visits at emergency room | Adalimumab (Humira) Treatment |
|---|---|
| Baseline (N=8) | 1.13 ± 0.354 |
| Month 12 (N=143) | 1.28 ± 0.883 |
| Month 24 (N=162) | 1.25 ± 0.558 |
| Month 36 (N=134) | 1.49 ± 0.865 |
| Month 48 (N=131) | 1.39 ± 0.686 |
| Month 60 (N=124) | 1.41 ± 0.817 |
| Month 72 (N=97) | 1.41 ± 0.826 |
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" and at least one admission to hospital at given timepoint..
| number of admissions to hospital | Adalimumab (Humira) Treatment |
|---|---|
| Baseline (N=10) | 1.30 ± 0.675 |
| Month 12 (N=230) | 1.29 ± 0.780 |
| Month 24 (N=255) | 1.26 ± 0.585 |
| Month 36 (N=229) | 1.41 ± 0.793 |
| Month 48 (N=180) | 1.54 ± 2.037 |
| Month 60 (N=197) | 1.60 ± 1.215 |
| Month 72 (N=180) | 1.83 ± 3.115 |
The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for "total days in hospital" at given timepoint.
| total days in hospital | Adalimumab (Humira) Treatment |
|---|---|
| Baseline (N=10) | 5.80 ± 3.259 |
| Month 12 (N=230) | 8.19 ± 9.801 |
| Month 24 (N=255) | 9.17 ± 11.753 |
| Month 36 (N=229) | 9.75 ± 19.474 |
| Month 48 (N=180) | 8.37 ± 10.011 |
| Month 60 (N=195) | 9.03 ± 12.997 |
| Month 72 (N=180) | 9.27 ± 13.158 |
Collected over Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adalimumab (Humira) Treatment | — | 1,853/5,025 (36.9%) | 958/5,025 (19.1%) |
| Event | Adalimumab (Humira) Treatment |
|---|---|
| CROHN'S DISEASEGastrointestinal disorders | 606/5025 |
| SMALL INTESTINAL OBSTRUCTIONGastrointestinal disorders | 131/5025 |
| INTESTINAL OBSTRUCTIONGastrointestinal disorders | 127/5025 |
| ANAL ABSCESSInfections and infestations | 119/5025 |
| ILEAL STENOSISGastrointestinal disorders | 94/5025 |
| ANAL FISTULAGastrointestinal disorders | 84/5025 |
| SUBILEUSGastrointestinal disorders | 68/5025 |
| ABDOMINAL PAINGastrointestinal disorders | 61/5025 |
| INTESTINAL STENOSISGastrointestinal disorders | 44/5025 |
| ABDOMINAL ABSCESSInfections and infestations | 43/5025 |
| Event | Adalimumab (Humira) Treatment |
|---|---|
| CROHN'S DISEASEGastrointestinal disorders | 81/5025 |
| PSORIASISSkin and subcutaneous tissue disorders | 66/5025 |
| HERPES ZOSTERInfections and infestations | 48/5025 |
| NASOPHARYNGITISInfections and infestations | 45/5025 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 38/5025 |
| URINARY TRACT INFECTIONInfections and infestations | 33/5025 |
| ANAEMIABlood and lymphatic system disorders | 30/5025 |
| ABDOMINAL PAINGastrointestinal disorders | 30/5025 |
| DIARRHOEAGastrointestinal disorders | 26/5025 |
| HEADACHENervous system disorders | 22/5025 |
All Treated Population: All participants who received at least 1 injection of Humira in the registry
| Age, Continuous(years) | Adalimumab (Humira) Treatment |
|---|---|
| Mean | 37.8 ± 12.7 |
| Sex: Female, Male(Participants) | Adalimumab (Humira) Treatment |
|---|---|
| Female | 2869 |
| Male | 2156 |
No study locations are listed for this record.
The record gives a start of Sep 2007, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2017, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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AbbVie (prior sponsor, Abbott) →