A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

AbbVie (prior sponsor, Abbott)5,025 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,025

Conditions

Crohn's Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in Abbvie sponsored investigational Crohn's disease (CD) trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial. * Subjects who were participants in AbbVie sponsored investigational Crohn's CD trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information. * Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information. * Subjects willing to consent to data being collected and provided to AbbVie. * Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol. Exclusion Criteria: \- Subjects should not be enrolled if they cannot be treated in accordance with the local product label.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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.