N/A
Completed N=4,107
Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
Source: ClinicalTrials.gov NCT01083680 ↗Enrolled (actual)
4,107
Serious AEs
13.3%
Results posted
Apr 2017
Primary outcomePrimary: Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit — -117; -124; -131; -137 units on a scale
Summary
The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit |
-117; -124; -131; -137; -142; -137 | — |
| PRIMARY Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time |
12.2; 28.8; 54.2; 4.8; 64.4; 17.4 | — |
| PRIMARY Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants |
10.8; 12.1; 12.6; 13.7; 13.2; 14.7 | — |
| PRIMARY Percentage of Participants With Adverse Events (Excluding Serious Adverse Events) |
16.7 | — |
| SECONDARY 4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time |
9.3; 4.8; 4.5; 4.2; 4.1; 3.9 | — |
| SECONDARY Compliance With the Self-injection Via the Humira®-PEN |
— | — |
Eligibility Criteria
Inclusion Criteria
- Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.
Exclusion Criteria
- Hypersensitivity against the drug or one of the other ingredients.
Data sourced from ClinicalTrials.gov (NCT01083680). 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.