N/A
Completed N=5,025
A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
Source: ClinicalTrials.gov NCT00524537 ↗Enrolled (actual)
5,025
Serious AEs
36.9%
Results posted
Jan 2017
Primary outcomePrimary: Number of Participants With Registry Treatment-Emergent Adverse Events (AEs) — 2392; 1853; 596; 43 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Registry Treatment-Emergent Adverse Events (AEs) |
2392; 1853; 596; 43 | — |
| SECONDARY Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit |
4.98; 4.20; 5.01; 5.51; 5.45; 5.41 | — |
| SECONDARY Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit |
-1.63; -1.63; -1.84; -1.91; -2.00; -2.08 | — |
| SECONDARY Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit |
-4.92; -3.02; -5.62; -3.93; -3.22; -3.89 | — |
| SECONDARY WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn's Disease From Baseline to Each Visit |
-8.00; -7.04; -9.84; -8.09; -8.21; -8.03 | — |
| SECONDARY WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn's Disease From Baseline to Each Visit |
-9.48; -7.95; -11.78; -9.15; -8.14; -9.33 | — |
| SECONDARY WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn's Disease From Baseline to Each Visit |
-10.93; -9.75; -10.07; -10.14; -10.78; -11.13 | — |
| SECONDARY Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit |
2.79; 1.95; 2.19; 2.38; 2.38; 2.39 | — |
| SECONDARY Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit |
1.13; 1.28; 1.25; 1.49; 1.39; 1.41 | — |
| SECONDARY Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit |
1.30; 1.29; 1.26; 1.41; 1.54; 1.60 | — |
| SECONDARY Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit |
5.80; 8.19; 9.17; 9.75; 8.37; 9.03 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00524537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.