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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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00667355
Date of registration: 24/04/2008
Prospective Registration: Yes
Primary sponsor: Abbott
Public title: A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Scientific title: A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Date of first enrolment: February 2008
Target sample size: 41
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00667355
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     Hideyuki Hashiba, BS
Address: 
Telephone:
Email:
Affiliation:  Abbott
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject who meets the definition of Ankylosing Spondylitis based on the Modified New
York Criteria, has a diagnosis of active Ankylosing Spondylitis and 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 joints to be assessed within 2 months prior
to the Screening



Age minimum: 15 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Biological: adalimumab
Primary Outcome(s)
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12 [Time Frame: Week 12]
Secondary Outcome(s)
Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in C-Reactive Protein (CRP) [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Chest Expansion [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Nocturnal Pain [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Patient's Global Assessment of Disease Activity [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44) [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46) [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Mean Change From Baseline in Total Back Pain [Time Frame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Number of Subjects Achieving ASAS 20 [Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Number of Subjects Achieving ASAS 50 [Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Number of Subjects Achieving ASAS 70 [Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6. [Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40) [Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission [Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) [Time Frame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit]
Secondary ID(s)
M10-239
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Eisai Co., Ltd.
Ethics review
Results
Results available: Yes
Date Posted: 11/08/2010
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00667355
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