N/A
Completed N=389
Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
Source: ClinicalTrials.gov NCT01464333 ↗Enrolled (actual)
389
Serious AEs
14.9%
Results posted
May 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 58; 104 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
58; 104 | — |
| SECONDARY Change in Crohn's Disease Activity Index (CDAI) Score Over Time |
193.68; 115.17; 108.43; 100.29; 108.81; 90.86 | — |
| SECONDARY Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time |
30.71; 11.86; 11.12; 7.04; 8.34; 10.34 | — |
| SECONDARY Change in WPAI: CD Presenteeism Over Time |
38.13; 24.57; 24.03; 19.85; 22.22; 27.69 | — |
| SECONDARY Change in WPAI: CD Overall Work Impairment Over Time |
42.68; 26.89; 25.85; 20.17; 23.89; 27.64 | — |
| SECONDARY Change in WPAI: CD Activity Impairment Over Time |
50.22; 29.22; 26.46; 23.66; 21.76; 26.51 | — |
| SECONDARY Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine) |
20; 17; 31; 35; 36; 7 | — |
| SECONDARY Change in C-Reactive Protein (CRP) Levels Over Time |
1.53; 0.43; 0.55; 0.53; 0.54; 0.49 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01464333). 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.