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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01901627
First Posted: July 17, 2013
Last Update Posted: July 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peking Union Medical College Hospital
  Purpose
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

Condition
Spondylitis, Ankylosing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Registry to Evaluate the Clinical Outcome of Chinese Adult Patients With Active Ankylosing Spondylitis Treated With Adalimumab in the Real World Practice

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Effectiveness of adalimumab, measured as percentage of patients achieving Bath Ankylosing Spondylitis Disease Activity Index *BASDAI* 50 at week12 with adalimumab treatment. [ Time Frame: week12 ]

Secondary Outcome Measures:
  • 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. [ Time Frame: week 12 ]
  • Proportion of patients who achieve each of the ASDAS disease state categories(inactive,mild,moderate,high) with adalimumab treatment. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: week 52 ]

Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adalimumab
Chinese adult patients with a diagnosis of AS who meet the requirements per the local label for treatment with adalimumab.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901627


Contacts
Contact: Jinmei Su, MD jinmei.su <jinmei.su@cstar.org.cn>

Locations
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Jinmei Su, MD    86-10-69158798    jinmei.su <jinmei.su@cstar.org.cn>   
Principal Investigator: Xiaofeng Zeng, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Xiaofeng Zeng, MD Peking Union Medical College Hospital
  More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01901627     History of Changes
Other Study ID Numbers: IMM-12-0115
First Submitted: May 14, 2013
First Posted: July 17, 2013
Last Update Posted: July 17, 2013
Last Verified: July 2013

Keywords provided by Peking Union Medical College Hospital:
Spondylitis, Ankylosing
adalimumab
Prospective Studies

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents