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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-JapicCTI-080580
Date of registration:
Prospective Registration: Yes
Primary sponsor: Abbott Japan Co., Ltd.
Public title: A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis
Scientific title: A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis
Date of first enrolment: 01/4/2008
Target sample size: 30
Recruitment status:
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-080580
Study type:  INTERVENTIONAL
Study design:  A Multi-Center, Open-Labeled Study  
Phase:  3
Countries of recruitment
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Abbott Japan Co., Ltd. Abbott Japan Clinical Trials Registration Desk   
Address:  E-mail: ABTJ-CTR@abbott.com
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: - Subject who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria
- Subject has a diagnosis of active Ankylosing Spondylitis
- Subject has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs

Exclusion criteria: - History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- Previously received anti-TNF therapy
- Spinal surgery or joint surgery involving to be assessed within 2 months prior to the Screening


Age minimum: 15
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Every other week,Subcutaneous, 40mg
Control intervention name : null
Primary Outcome(s)
Assessment in Ankylosing Spondylitis 20 (ASAS 20)
Secondary Outcome(s)
ASAS 50
ASAS 70
BASDAI 50
Evaluation of adverse event, vital sign, laboratory tests
Secondary ID(s)
Source(s) of Monetary Support
Refer to the information of contact(s)
Secondary Sponsor(s)
Eisai Co., Ltd.
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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