Clinical trial NCT00667355: A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Official title: A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Eisai Co., Ltd.
First posted: 2008-04-28
Enrollment: 41
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis

Detailed description: It is reported that the prevalence of Ankylosing Spondylitis (AS) in Japanese patients is extremely lower than that of Caucasians; therefore, a controlled, double-blind study with similar sample size in Western studies for active AS in Japan was not able to be conducted. As a result, this study was conducted with an open-label design to investigate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active AS. The inclusion criteria and primary endpoint measurement (Achieving Assessment in Ankylosing Spondylitis 20 at Week 12) were designed the same as the Western studies for active AS in consideration with the confirmation of Western data. Treatment with adalimumab was to be continued until the approval of adalimumab for AS in Japanese subjects with active AS.

Eligibility 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

Primary outcomes:
measure: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Subjects Achieving ASAS 20
timeFrame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Number of Subjects Achieving ASAS 50
timeFrame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Number of Subjects Achieving ASAS 70
timeFrame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)
timeFrame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Patient's Global Assessment of Disease Activity
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Total Back Pain
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in C-Reactive Protein (CRP)
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.
timeFrame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)
timeFrame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission
timeFrame: Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Chest Expansion
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Nocturnal Pain
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
measure: Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire
timeFrame: Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference # / Investigator 46791
city: Fukui
country: Japan
facility: Site Reference # / Investigator 46789
city: Fukuoka
country: Japan
facility: Site Reference # / Investigator 46798
city: Fukuoka
country: Japan
facility: Site Reference # / Investigator 46799
city: Hiroshima
country: Japan
facility: Site Reference # / Investigator 46796
city: Hokkaido
country: Japan
facility: Site Reference # / Investigator 46782
city: Hokkaido
country: Japan
facility: Site Reference # / Investigator 7297
city: Hyogo
country: Japan
facility: Site Reference # / Investigator 46795
city: Kagawa
country: Japan
facility: Site Reference # / Investigator 46797
city: Kanagawa
country: Japan
facility: Site Reference # / Investigator 46787
city: Nagano
country: Japan
facility: Site Reference # / Investigator 46790
city: Osaka
country: Japan
facility: Site Reference # / Investigator 46793
city: Osaka
country: Japan
facility: Site Reference # / Investigator 46794
city: Saitama
country: Japan
facility: Site Reference # / Investigator 46783
city: Saitama
country: Japan
facility: Site Reference # / Investigator 46784
city: Shiga
country: Japan
facility: Site Reference # / Investigator 46792
city: Tokyo
country: Japan
facility: Site Reference # / Investigator 46785
city: Tokyo
country: Japan
facility: Site Reference # / Investigator 46786
city: Toyama
country: Japan
facility: Site Reference # / Investigator 46788
Study officials:
affiliation: Abbott
name: Hideyuki Hashiba, BS
role: STUDY_DIRECTOR
References: