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

NCT ID: NCT01901627

Last Updated: 2013-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Spondylitis, Ankylosing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adalimumab

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaofeng Zeng, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinmei Su, MD

Role: CONTACT

Facility Contacts

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Jinmei Su, MD

Role: primary

Other Identifiers

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IMM-12-0115

Identifier Type: -

Identifier Source: org_study_id

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