A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life (CIMAX)

UCB

Status: Completed

Conditions: Axial Spondyloarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02354105

AS0002

Details and patient eligibility

About

The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.

Enrollment: 680 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient personally signed and dated a Patient Data Consent Form (PDCF) prior to Visit 2. No data can be entered into the electronic Documentation form (eDF) prior to signature of the PDCF.
• The patient must have a clinical diagnosis of active axial spondyloarthritis (axSpA), [ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA)] according to the diagnostic criteria used by the physician in routine clinical practice.
• The decision to prescribe Certolizumab Pegol (CZP) is made by the physician independent of the patient's participation in the NIS.
• The patient must be newly prescribed CZP according to local regulations or guidelines (eg, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4).
• Treatment is according to instructions in the Summary of Product Characteristics (SmPC) for patients considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires).
• If a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study.

Exclusion criteria

N/A

Trial design

680 participants in 1 patient group

CZP treatment

Description:

axSpA patients who have been newly prescribed Certolizumab Pegol (CZP).