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A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference # / Investigator 46791
  • Site Reference # / Investigator 46789
  • Site Reference # / Investigator 46798
  • Site Reference # / Investigator 46799
  • Site Reference # / Investigator 46796
  • Site Reference # / Investigator 46782
  • Site Reference # / Investigator 7297
  • Site Reference # / Investigator 46795
  • Site Reference # / Investigator 46797
  • Site Reference # / Investigator 46787
  • Site Reference # / Investigator 46790
  • Site Reference # / Investigator 46793
  • Site Reference # / Investigator 46794
  • Site Reference # / Investigator 46783
  • Site Reference # / Investigator 46784
  • Site Reference # / Investigator 46792
  • Site Reference # / Investigator 46785
  • Site Reference # / Investigator 46786
  • Site Reference # / Investigator 46788

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at 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 Outcome Measures

Number of Subjects Achieving ASAS 20
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 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.
Number of Subjects Achieving ASAS 50
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = at least 50% improvement (vs. baseline) and an absolute improvement ≥ 20 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.
Number of Subjects Achieving ASAS 70
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = at least 70% improvement (vs. baseline) and an absolute improvement ≥ 30 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.
Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)
BASDAI is a validated self assessment tool used to determine disease activity in subjects with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI.
Mean Change From Baseline in Patient's Global Assessment of Disease Activity
Subject's assessment of disease activity using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = none and 100 = severe).
Mean Change From Baseline in Total Back Pain
Subject assessed his/her back pain by using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = no pain and 100 = most severe pain).
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is a validated self assessment tool that determines the degree of functional limitation in AS subjects. Utilizing a VAS of 0-100 mm (0=easy, 100=impossible), subjects answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
Mean Change From Baseline in C-Reactive Protein (CRP)
CRP is a marker of inflammation and measured in mg/dL. A higher level is consistent with inflammation.
Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.
ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains (each domain measured on a 0 - 100 scale [0 = no disease activity; 100 = high disease activity]).
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = at least 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission
Partial remission is defined as a score of less than 20 units (on a scale of 0-100; 0=no disease activity and 100=high disease activity) in each of the 4 Assessments in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation.
Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total score ranging from 0 to 10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.
Mean Change From Baseline in Chest Expansion
Chest expansion is the difference in centimeters between full expiration and full inspiration, measured at the 4th inter-costal space. An increase in chest expansion represents improvement.
Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).
Mean Change From Baseline in Nocturnal Pain
Nocturnal pain assessed by subjects using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = no pain and 100 = worst possible pain).
Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)
The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).
Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)
The number of tender or painful joints among 23 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender or painful joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender or painful joints) to 46 (worst possible score; all joints tender or painful).
Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These are summarized in a physical component summary (PCS) and mental component summary (MCS) score. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=lowest level of functioning; 100=highest level of functioning).

Full Information

First Posted
April 24, 2008
Last Updated
January 24, 2012
Sponsor
Abbott
Collaborators
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00667355
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
Collaborators
Eisai Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
40 mg or 80 mg every other week, subcutaneous
Primary Outcome Measure Information:
Title
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving ASAS 20
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 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.
Time Frame
Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Number of Subjects Achieving ASAS 50
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = at least 50% improvement (vs. baseline) and an absolute improvement ≥ 20 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.
Time Frame
Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Number of Subjects Achieving ASAS 70
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = at least 70% improvement (vs. baseline) and an absolute improvement ≥ 30 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.
Time Frame
Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)
Description
BASDAI is a validated self assessment tool used to determine disease activity in subjects with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI.
Time Frame
Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Patient's Global Assessment of Disease Activity
Description
Subject's assessment of disease activity using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = none and 100 = severe).
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Total Back Pain
Description
Subject assessed his/her back pain by using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = no pain and 100 = most severe pain).
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI is a validated self assessment tool that determines the degree of functional limitation in AS subjects. Utilizing a VAS of 0-100 mm (0=easy, 100=impossible), subjects answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in C-Reactive Protein (CRP)
Description
CRP is a marker of inflammation and measured in mg/dL. A higher level is consistent with inflammation.
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.
Description
ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains (each domain measured on a 0 - 100 scale [0 = no disease activity; 100 = high disease activity]).
Time Frame
Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)
Description
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = at least 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time Frame
Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission
Description
Partial remission is defined as a score of less than 20 units (on a scale of 0-100; 0=no disease activity and 100=high disease activity) in each of the 4 Assessments in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation.
Time Frame
Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total score ranging from 0 to 10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Chest Expansion
Description
Chest expansion is the difference in centimeters between full expiration and full inspiration, measured at the 4th inter-costal space. An increase in chest expansion represents improvement.
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Description
Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Nocturnal Pain
Description
Nocturnal pain assessed by subjects using a Visual Analog Scale (VAS) of 0 - 100 mm (0 = no pain and 100 = worst possible pain).
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)
Description
The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)
Description
The number of tender or painful joints among 23 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender or painful joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender or painful joints) to 46 (worst possible score; all joints tender or painful).
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit
Title
Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These are summarized in a physical component summary (PCS) and mental component summary (MCS) score. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=lowest level of functioning; 100=highest level of functioning).
Time Frame
Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hideyuki Hashiba, BS
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference # / Investigator 46791
City
Aichi
Country
Japan
Facility Name
Site Reference # / Investigator 46789
City
Fukui
Country
Japan
Facility Name
Site Reference # / Investigator 46798
City
Fukuoka
Country
Japan
Facility Name
Site Reference # / Investigator 46799
City
Fukuoka
Country
Japan
Facility Name
Site Reference # / Investigator 46796
City
Hiroshima
Country
Japan
Facility Name
Site Reference # / Investigator 46782
City
Hokkaido
Country
Japan
Facility Name
Site Reference # / Investigator 7297
City
Hokkaido
Country
Japan
Facility Name
Site Reference # / Investigator 46795
City
Hyogo
Country
Japan
Facility Name
Site Reference # / Investigator 46797
City
Kagawa
Country
Japan
Facility Name
Site Reference # / Investigator 46787
City
Kanagawa
Country
Japan
Facility Name
Site Reference # / Investigator 46790
City
Nagano
Country
Japan
Facility Name
Site Reference # / Investigator 46793
City
Osaka
Country
Japan
Facility Name
Site Reference # / Investigator 46794
City
Osaka
Country
Japan
Facility Name
Site Reference # / Investigator 46783
City
Saitama
Country
Japan
Facility Name
Site Reference # / Investigator 46784
City
Saitama
Country
Japan
Facility Name
Site Reference # / Investigator 46792
City
Shiga
Country
Japan
Facility Name
Site Reference # / Investigator 46785
City
Tokyo
Country
Japan
Facility Name
Site Reference # / Investigator 46786
City
Tokyo
Country
Japan
Facility Name
Site Reference # / Investigator 46788
City
Toyama
Country
Japan

12. IPD Sharing Statement

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A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

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