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

Abbott

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01076959

P10-559

Details and patient eligibility

About

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

Enrollment: 7,972 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

7,972 participants in 1 patient group

Humira

Description:

The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the PMDA. The safety analysis set included all patients who met all eligibility criteria and received at least one dose of Humira. The full analysis set included all patients who were treated with Humira for at least 2 weeks and had complete DAS 28 assessments at baseline and at least one other time point.