A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis
Phase 3
- Conditions
- Ankylosing Spondylitis
- Registration Number
- JPRN-jRCT2080220558
- Lead Sponsor
- Abbott Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment in Ankylosing Spondylitis 20 (ASAS 20)
- Secondary Outcome Measures
Name Time Method ASAS 50<br>ASAS 70<br>BASDAI 50<br>Evaluation of adverse event, vital sign, laboratory tests