N/A
N=7,740
Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01076959 ↗Enrolled (actual)
7,740
Serious AEs
6.1%
Results posted
Aug 2012
Primary outcome: Primary: Total Number of Patients With Adverse Events — 27.8 Percentage of Patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Patients With Adverse Events |
27.8 | — |
| PRIMARY Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 |
20.4; 45.7; 33.9; 66.1 | — |
| PRIMARY Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 |
26.4; 42.6; 31.1; 68.9 | — |
| PRIMARY Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 |
30.7; 39.3; 29.9; 70.1 | — |
| SECONDARY Physicians' Overall Effectiveness Response Rating |
29.1; 45.2; 19.6; 6.1 | — |
Summary
To clarify the following matters:
* Unknown adverse reactions (especially clinically significant adverse reactions)
* Incidence and conditions of occurrence of adverse reactions in the clinical setting
* Factors that may affect the safety and effectiveness of Humira
Eligibility Criteria
Inclusion Criteria
- All patients prescribed and treated with Humira are included in this 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 cardiac failure congestive.
Data sourced from ClinicalTrials.gov (NCT01076959). 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.