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

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

Study Overview

• Status: Unknown
• Conditions: Spondylitis, Ankylosing

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Jinmei Su, MD; Email: jinmei.su <jinmei.su@cstar.org.cn>

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Jinmei Su, MD; Phone Number: 86-10-69158798; Email: jinmei.su <jinmei.su@cstar.org.cn>

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of ankylosing spondylitis(any disease duration) who meet the requirements per the local label for treatment with adalimumab.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adalimumab; Chinese adult patients with a diagnosis of AS who meet the requirements per the local label for treatment with adalimumab.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Physician Global Assessment*PGA*. Inflammatory Bowel Disease *IBD*	week 12
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): July 17, 2013
• Last Update Submitted That Met QC Criteria: July 12, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Prospective Studies; adalimumab; Spondylitis, Ankylosing
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: IMM-12-0115