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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01901627
First received: May 14, 2013
Last updated: July 12, 2013
Last verified: July 2013
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve each of the ASDAS disease state categories(inactive,mild,moderate,high) with adalimumab treatment. [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01901627     History of Changes
Other Study ID Numbers: IMM-12-0115
Study First Received: May 14, 2013
Last Updated: July 12, 2013
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014