Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

AbbVie

Status: Completed

Conditions: Ankylosing Spondylitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01329380

P12-764

Details and patient eligibility

About

This study of adalimumab (Humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug:

• Unknown adverse drug reactions (especially important adverse drug reactions)
• Incidence and conditions of occurrence of adverse reactions in the clinical setting
• Factors that may affect the safety and effectiveness of Humira

Enrollment: 403 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the 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 congestive cardiac failure

Trial design

403 participants in 1 patient group

Adalimumab

Description:

Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.