A Multicenter Registry of Adalimumab in Chinese Adult Patients With Active Ankylosing Spondylitis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Spondylitis, Ankylosing

Study type: Observational

Funder types: Other

Identifiers

NCT01901627

IMM-12-0115

Details and patient eligibility

About

A multicenter registry to explore the clinical outcome of Chinese adult patients with active Ankylosing Spondylitis *AS* treated with adalimumab,prescribed according to the local label,in the real world practice

Full description

This registry will be conducted in a non-interventional setting for AS patients using adalimumab in China.The primary objective is to evaluate the effectiveness and safety of adalimumab in Chinese AS patients in real world clinical practice.The secondary objective is to 1)compare the clinical outcome in patients with or without good persistence with adalimumab;2)investigate the predicting factors of a good clinical response after discontinuation of adalimumab.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients with established diagnosis of ankylosing spondylitis.
2. Patients eligible to use adalimumab according to the local label without any contraindication.(According to the local label, patients should be screened for active infection,TB,HBV,malignancy and CHF before the prescription of adalimumab,patients with latent TB should start a full course of anti-TB therapy before the use of adalimumab.)

Exclusion criteria

1.Patients with contraindication or are not appropriate to use adalimumab according to the local label will be excluded

Trial design

400 participants in 1 patient group

Adalimumab

Description:

Chinese adult patients with a diagnosis of AS who meet the requirements per the local label for treatment with adalimumab.