Clinical trial NCT00524537: A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
Official title: A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 5025
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Crohn's disease who have been prescribed adalimumab according to the local label.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)
timeFrame: 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:
measure: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
measure: Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit
timeFrame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References:
citation: D'Haens G, Reinisch W, Panaccione R, Satsangi J, Petersson J, Bereswill M, Arikan D, Perotti E, Robinson AM, Kalabic J, Alperovich G, Thakkar R, Loftus EV. Lymphoma Risk and Overall Safety Profile of Adalimumab in Patients With Crohn's Disease With up to 6 Years of Follow-Up in the Pyramid Registry. Am J Gastroenterol. 2018 Jun;113(6):872-882. doi: 10.1038/s41395-018-0098-4. Epub 2018 Jun 5.