An observational study in Crohn's Disease, sponsored by AbbVie (prior sponsor, Abbott). Completed. Per ClinicalTrials.gov, last updated 2019-05-20.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 511 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.
Those who are receiving Humira in accordance with its indications for treatment and dosage regimens.
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:
Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
Number of Participants With Adverse Events
An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details.
Time frame: From first dose of Humira up to 3 years
Change in Crohn's Disease Activity Index (CDAI) Score Over Time
The Change in Crohn's Disease Activity Index (CDAI) is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. A negative change from Baseline indicates improvement.
Time frame: From first dose of Humira up to 3 years
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to CD) is calculated as the number of hours of work missed due to CD / (number of hours of work missed due to CD + number of hours worked) \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: From first dose of Humira up to 3 years
Change in WPAI: CD Presenteeism Over Time
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to CD ) is calculated as the patient's rating of how much CD affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: From first dose of Humira up to 3 years
Change in WPAI: CD Overall Work Impairment Over Time
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment \[OWI\]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: From first dose of Humira up to 3 years
Change in WPAI: CD Activity Impairment Over Time
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to CD ) is calculated as the patient's rating of how much CD affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: From first dose of Humira up to 3 years
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
Endoscopic remission per endoscopy sub score.
Time frame: From first dose of Humira up to 3 years
Change in C-Reactive Protein (CRP) Levels Over Time
CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.
Time frame: From first dose of Humira up to 3 years
| Milestone | Humira |
|---|---|
| Started | 389 |
| Completed | 226 |
| Not completed | 163 |
| Withdrew: Adverse event | 34 |
| Withdrew: Lack of efficacy | 72 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Other | 4 |
| Withdrew: No hospital visit | 42 |
An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details.
| participants | Humira |
|---|---|
| Serious Adverse Events | 58 |
| Non-serious Adverse Events | 104 |
The Change in Crohn's Disease Activity Index (CDAI) is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. A negative change from Baseline indicates improvement.
| units on a scale | Humira |
|---|---|
| At first administration | 193.68 ± 103.00 |
| Week 4 of administration | 115.17 ± 72.21 |
| Month 3 of administration | 108.43 ± 80.45 |
| Month 6 of administration | 100.29 ± 84.14 |
| Year 1 of administration | 108.81 ± 83.40 |
| Year 1 and Month 6 of administration | 90.86 ± 71.84 |
| Year 2 of administration | 93.90 ± 75.99 |
| Year 2 and Month 6 of administration | 88.92 ± 76.62 |
| Year 3 of administration | 94.89 ± 81.61 |
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to CD) is calculated as the number of hours of work missed due to CD / (number of hours of work missed due to CD + number of hours worked) \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
| percentage of work time missed | Humira |
|---|---|
| At first administration | 30.71 ± 42.35 |
| Week 4 of administration | 11.86 ± 28.81 |
| Month 3 of administration | 11.12 ± 28.17 |
| Month 6 of administration | 7.04 ± 22.35 |
| Year 1 of administration | 8.34 ± 24.94 |
| Year 1 and Month 6 of administration | 10.34 ± 28.03 |
| Year 2 of administration | 5.49 ± 19.54 |
| Year 2 and Month 6 of administration | 7.33 ± 23.26 |
| Year 3 of administration | 4.69 ± 21.30 |
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to CD ) is calculated as the patient's rating of how much CD affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
| Percent impairment while working | Humira |
|---|---|
| At first administration | 38.13 ± 32.87 |
| Week 4 of administration | 24.57 ± 27.07 |
| Month 3 of administration | 24.03 ± 26.91 |
| Month 6 of administration | 19.85 ± 27.47 |
| Year 1 of administration | 22.22 ± 28.93 |
| Year 1 and Month 6 of administration | 27.69 ± 32.80 |
| Year 2 of administration | 21.85 ± 24.18 |
| Year 2 and Month 6 of administration | 20.40 ± 29.08 |
| Year 3 of administration | 14.21 ± 24.11 |
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment \[OWI\]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
| Percent overall work impairment | Humira |
|---|---|
| At first administration | 42.68 ± 34.71 |
| Week 4 of administration | 26.89 ± 28.45 |
| Month 3 of administration | 25.85 ± 30.40 |
| Month 6 of administration | 20.17 ± 28.63 |
| Year 1 of administration | 23.89 ± 30.43 |
| Year 1 and Month 6 of administration | 27.64 ± 33.18 |
| Year 2 of administration | 22.83 ± 26.22 |
| Year 2 and Month 6 of administration | 19.77 ± 29.93 |
| Year 3 of administration | 14.27 ± 25.06 |
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to CD ) is calculated as the patient's rating of how much CD affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 \* 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
| Percent activity impairment | Humira |
|---|---|
| At first administration | 50.22 ± 31.45 |
| Week 4 of administration | 29.22 ± 26.64 |
| Month 3 of administration | 26.46 ± 26.82 |
| Month 6 of administration | 23.66 ± 25.22 |
| Year 1 of administration | 21.76 ± 24.36 |
| Year 1 and Month 6 of administration | 26.51 ± 25.98 |
| Year 2 of administration | 21.52 ± 21.91 |
| Year 2 and Month 6 of administration | 24.88 ± 25.01 |
| Year 3 of administration | 14.62 ± 18.60 |
Endoscopic remission per endoscopy sub score.
| Participants | Humira |
|---|---|
| Large intestine: start of administration | 20 |
| Large intestine: Month 6 of administration | 17 |
| Large intestine: Year 1 of administration | 31 |
| Large intsetine: Year 2 of administration | 35 |
| Large intestine: Year 3 of administration | 36 |
| Small intestine: at first administration | 7 |
| Small intestine: Month 6 of administration | 15 |
| Small intestine: Year 1 of administration | 25 |
| Small intestine: Year 2 of administration | 16 |
| Small intestine: Year 3 of administration | 19 |
| Both intestine: start of administration | 2 |
| Both intestine: Mont 6 of administration | 5 |
| Both intestine: Year 1 of administration | 16 |
| Both intestine: Year 2 of administration | 8 |
| Both intestine: Year 3 of administration | 11 |
CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.
| mg/dL | Humira |
|---|---|
| At first administration | 1.53 ± 2.00 |
| Week 4 of administration | 0.43 ± 0.99 |
| Month 3 of administration | 0.55 ± 1.09 |
| Month 6 of administration | 0.53 ± 1.18 |
| Year 1 of administration | 0.54 ± 1.00 |
| Year 1 and Month 6 of administration | 0.49 ± 1.31 |
| Year 2 of administration | 0.44 ± 1.03 |
| Year 2 and Month 6 of administration | 0.52 ± 1.38 |
| Year 3 of administration | 0.66 ± 2.90 |
Collected over Treatment emergent adverse events (TEAEs) were collected from the first dose of study drug until the end of the study (up to 160 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Humira | 3/389 (0.8%) | 58/389 (14.9%) | 104/389 (26.7%) |
| Event | Humira |
|---|---|
| Crohn's diseaseGastrointestinal disorders | 8/389 |
| Ileal stenosisGastrointestinal disorders | 4/389 |
| Intestinal stenosisGastrointestinal disorders | 4/389 |
| Small intestinal stenosisGastrointestinal disorders | 4/389 |
| IleusGastrointestinal disorders | 3/389 |
| Pancreatitis acuteGastrointestinal disorders | 3/389 |
| Anal abscessInfections and infestations | 2/389 |
| Abdominal abscessInfections and infestations | 2/389 |
| Small intestinal obstructionGastrointestinal disorders | 2/389 |
| PyrexiaGeneral disorders | 2/389 |
| Event | Humira |
|---|---|
| C-reactive protein increasedInvestigations | 12/389 |
| NasopharyngitisInfections and infestations | 8/389 |
| Crohn's diseaseGastrointestinal disorders | 8/389 |
| AnaemiaBlood and lymphatic system disorders | 4/389 |
| Iron deficiency anaemiaBlood and lymphatic system disorders | 4/389 |
| RashSkin and subcutaneous tissue disorders | 4/389 |
| PyrexiaGeneral disorders | 4/389 |
| Herpes zosterInfections and infestations | 3/389 |
| Anal abscessInfections and infestations | 3/389 |
| Abdominal painGastrointestinal disorders | 3/389 |
Safety analysis set
| Age, Continuous(years) | Humira |
|---|---|
| Mean | 34.0 ± 11.8 |
| Sex: Female, Male(Participants) | Humira |
|---|---|
| Female | 106 |
| Male | 283 |
| Race and Ethnicity Not Collected(Participants) | Humira |
|---|
| Region of Enrollment(participants) | Humira |
|---|---|
| Japan | 389 |
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Dec 2011 to primary completion in Mar 2018, 75 months.
Results were first posted in May 2019, 1 year 1 month after primary completion.
Of 73 industry-sponsored observational studies under Crohn Disease, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 60. This study's 75 months is above that.
Counting every sponsor, half of 296 studies reached it within 42 months; a quarter within 29 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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AbbVie (prior sponsor, Abbott) →