A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 19
- Primary Endpoint
- Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Adalimumab
Adalimumab 40 mg or 80 mg subcutaneously (SC) administered every other week (eow) until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan. All subjects received 40 mg of adalimumab SC eow at Baseline. The subjects who completed 16 weeks of therapy and who failed to achieve Assessments in Ankylosing Spondylitis 20 (ASAS 20) response on or after Week 16, could increase the dose of adalimumab to 80 mg eow. When the dose was increased, the higher dose was to be continued during the rest of the study.
Intervention: adalimumab (Biological)
Outcomes
Primary Outcomes
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12
Time Frame: Week 12
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = at least 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0 - 100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.
Secondary Outcomes
- Mean Change From Baseline in Total Back Pain(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Number of Subjects Achieving ASAS 50(Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in C-Reactive Protein (CRP)(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)(Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in Chest Expansion(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission(Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Number of Subjects Achieving ASAS 20(Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Number of Subjects Achieving ASAS 70(Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in Patient's Global Assessment of Disease Activity(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.(Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)(Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in Nocturnal Pain(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)
- Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)(Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit)