Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis

Abbott7,972 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

7,972

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1723)

Outcomes

Primary Outcomes

Total Number of Patients With Adverse Events

Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.

Time frame: Baseline to Week 24

Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4

Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

Time frame: Week 4

Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12

Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

Time frame: Week 12

Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24

Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

Time frame: Week 24

Secondary Outcomes

Data from ClinicalTrials.gov

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Site Reference ID/Investigator# 35904

Aichi, Japan

Site Reference ID/Investigator# 35905

Aichi, Japan

Site Reference ID/Investigator# 35906

Aichi, Japan

Site Reference ID/Investigator# 35907

Aichi, Japan

Site Reference ID/Investigator# 35908

Aichi, Japan

Site Reference ID/Investigator# 35909

Aichi, Japan

Site Reference ID/Investigator# 35912

Aichi, Japan

Site Reference ID/Investigator# 35913

Aichi, Japan

Site Reference ID/Investigator# 35914

Aichi, Japan

Site Reference ID/Investigator# 35915

Aichi, Japan

...and 1713 more locations