Surveillance of Humira Injection in Korean Patients

AbbVie

Status: Completed

Conditions: Psoriasis; Psoriatic Arthritis; Crohn's Disease; Ankylosing Spondylitis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01083121

P10-053

Details and patient eligibility

About

Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.

Enrollment: 1,779 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (19 years and above) with one of the following indications:

  • Moderately to severely active rheumatoid arthritis or
  • active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate or
  • severe active ankylosing spondylitis who have had an inadequate response to conventional therapy or
  • severely active Crohn's disease who have had no response, intolerance or contraindication to corticosteroid therapy or immunosuppressants or
  • moderately to severely active psoriasis patients who have had no response, have intolerance or have contraindication to systemic therapies including cyclosporine, methotrexate or photochemotherapy (PUVA).

• Patients who give verbal or written authorization to use their personal and health data.

Exclusion criteria

• Patients with known hypersensitivity to adalimumab or any of its excipients.

Trial design

1,779 participants in 1 patient group

Adalimumab

Description:

Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.