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

• Conditions: Spondylitis, Ankylosing

• Registration Number: NCT01901627
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-14
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-12
• Last Update Submitted: 2013-07-12
• Study First Posted: 2013-07-17
• Last Update Posted: 2013-07-17
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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\*
BASDAI50 response rate at week 26 and week52 in patients still on adalimumab compared to patients who discontinued adalimumab early.	week26 and 52
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China