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

A Multicenter Registry to Evaluate the Clinical Outcome of Chinese Adult Patients With Active Ankylosing Spondylitis Treated With Adalimumab in the Real World Practice

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01901627

Enrollment

400

Registered

2013-07-17

Start date

2013-04-30

Completion date

2015-06-30

Last updated

2013-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylitis, Ankylosing

Keywords

Spondylitis, Ankylosing, adalimumab, Prospective Studies

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Effectiveness of adalimumab, measured as percentage of patients achieving Bath Ankylosing Spondylitis Disease Activity Index BASDAI 50 at week12 with adalimumab treatment.	week12

Secondary

Measure	Time frame	Description
Proportion of patients who achieve each of the ASDAS disease state categories(inactive,mild,moderate,high) with adalimumab treatment.	week 12	—
Improvement of extra-articular manifestation with adalimumab treatment compared to baseline: uveitis flare rates, patient proportion with VAS scale at 1 in IBD PtGA, patient proportion with skin lesion clear or almost clear in psoriasis PGA.	week 12	Physician Global Assessment\PGA\. Inflammatory Bowel Disease \IBD\
Effectiveness of adalimumab measured as change in BASDAI,Ankylosing Spondylitis Disease Activity Scores ASDAS,Visual Analogue Scale VAS in pain,Patient Global Assessment PtGA with adalimumab treatment.	week 12	—
Change in BASDAI, ASDAS, and VAS in pain and PtGA in patients still on adalimumab compared to patients who discontinued adalimumab early.	week 26 and 52	—
Factors influencing the clinical response evaluated by the relapse rate(defined as BASDAI≥4) after discontinuation of adalimumab in patients who achieved BASDAI <4 and do not restart biologics in the follow-up	week 52	—
BASDAI50 response rate at week 26 and week52 in patients still on adalimumab compared to patients who discontinued adalimumab early.	week26 and 52	—

Countries

China

Contacts

Primary ContactJinmei Su, MD

jinmei.su <jinmei.su@cstar.org.cn>

Outcome results