N/A
Completed N=1,716
Special Investigation in Patients With Crohn's Disease (All Patients Investigation)
Source: ClinicalTrials.gov NCT01298648 ↗Enrolled (actual)
1,716
Serious AEs
8.7%
Results posted
Mar 2014
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 453; 147; 360; 96 participants
Summary
This study will be conducted to assess adverse drug reactions, incidence of adverse events, and factors that may affect the safety and effectiveness of Humira for the treatment of Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
453; 147; 360; 96 | — |
| PRIMARY Crohn's Disease Activity Index (CDAI) at Baseline and Week 4 |
204.3; 142.9 | <0.0001 sig |
| PRIMARY Crohn's Disease Activity Index (CDAI) at Baseline and Week 8 |
204.3; 142.7 | <0.0001 sig |
| PRIMARY Crohn's Disease Activity Index (CDAI) at Baseline and Week 24 |
204.3; 149.1 | <0.0001 sig |
| SECONDARY Improvement Rating by Investigator at Week 24 |
20.6; 55.3; 17.2; 7.0 | — |
| SECONDARY Remission Rate at Week 4, Week 8, and Week 24 |
46.8; 48.0; 46.8 | — |
Eligibility Criteria
Inclusion Criteria
- All patients with moderate or severe active Crohn's disease who are not responding well to conventional therapy and receive Humira will be enrolled in the survey
Exclusion Criteria
Contraindications according to the Package Insert
- Patients who have serious infections
- Patients who have tuberculosis
- Patients with a history of hypersensitivity to any ingredient of Humira
- Patients who have demyelinating disease or with a history of demyelinating disease
- Patients who have congestive cardiac failure
Data sourced from ClinicalTrials.gov (NCT01298648). 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.