Special Investigation (Long-term Investigation) in Patients With Crohn's Disease

Humira® for Subcutaneous Injection Protocol for Special Investigation (Long-term Treatment for Crohn's Disease Patients)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01464333

Enrollment

511

Registered

2011-11-03

Start date

2011-12-16

Completion date

2018-03-31

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with Crohn's disease indicated for Humira treatment with the recommended dosage regimen * Patients with no past- or present malignant tumors * Patients who are not currently receiving Humira

Exclusion criteria

* None.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events	From first dose of Humira up to 3 years	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.

Secondary

Measure	Time frame	Description
Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time	From first dose of Humira up to 3 years	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.
Change in WPAI: CD Presenteeism Over Time	From first dose of Humira up to 3 years	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.
Change in WPAI: CD Overall Work Impairment Over Time	From first dose of Humira up to 3 years	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.
Change in Crohn's Disease Activity Index (CDAI) Score Over Time	From first dose of Humira up to 3 years	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.
Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)	From first dose of Humira up to 3 years	Endoscopic remission per endoscopy sub score.
Change in C-Reactive Protein (CRP) Levels Over Time	From first dose of Humira up to 3 years	CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.
Change in WPAI: CD Activity Impairment Over Time	From first dose of Humira up to 3 years	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.

Participant flow

Pre-assignment details

Of the 511 patients enrolled, case report forms were not collected from 7 patients (N = 504). The safety analysis set excluded 115 enrolled patients due to safety assessment impossible (N = 389). The efficacy analysis set excluded 79 patients that were included in the safety analysis set due to efficacy assessment impossible (N = 310).

Participants by arm

Arm	Count
Humira Participants who were prescribed Humira per approved prescribing information of Humira in Japan.	389
Total	389

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	34
Overall Study	Lack of Efficacy	72
Overall Study	No Hospital Visit	42
Overall Study	Other	4
Overall Study	Withdrawal by Subject	11

Baseline characteristics

Characteristic	Humira	—
Age, Continuous	34.0 years STANDARD_DEVIATION 11.8	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Japan	389 participants	—
Sex: Female, Male Female	106 Participants	—
Sex: Female, Male Male	283 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	3 / 389
other Total, other adverse events	104 / 389
serious Total, serious adverse events	58 / 389

Outcome results

Primary

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.