N/A
N=473
Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)
Behcet's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01960790 ↗Enrolled (actual)
473
Serious AEs
16.2%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants With Adverse Drug Reactions — 47; 5; 6; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
47; 5; 6; 1; 3; 1 | — |
| SECONDARY Global Assessment of Gastrointestinal Symptoms |
52; 55; 76; 88; 98; 153 | — |
| SECONDARY Global Assessment of Gastrointestinal Symptoms of Behcet's Disease |
89; 56; 74; 82; 67; 181 | — |
| SECONDARY Number of Participants With Cardinal Symptoms of Behcet's Disease |
99; 84; 7; 29; 74; 59 | — |
| SECONDARY Number of Participants With Accessory Symptoms of Behcet's Disease |
150; 39; 11; 21; 115; 36 | — |
| SECONDARY Number of Participants With Degree of Improvement of Endoscopic Findings |
64; 38; 24; 9; 2; 73 | — |
| SECONDARY Changes in C-reactive Protein (CRP) |
2.0239; 0.5389; 0.5504; 0.3348; 0.4031; 0.5034 | — |
Summary
This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease.
1. Incidence and conditions of occurrence of adverse reactions in clinical practice
2. Factors likely to affect the safety and effectiveness
Eligibility Criteria
Inclusion Criteria
- All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator)
Exclusion Criteria
Contraindications according to the Package Insert include patients who had any of the following:
- serious infections
- tuberculosis
- a history of hypersensitivity to any ingredient of Humira®
- demyelinating disease or a history of demyelinating disease
- congestive cardiac failure
Data sourced from ClinicalTrials.gov (NCT01960790). 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.