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A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00667355
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : August 11, 2010
Last Update Posted : January 26, 2012
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Intervention Biological: adalimumab
Enrollment 41

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Period Title: Overall Study
Started 41
Completed 30
Not Completed 11
Reason Not Completed
Adverse Event             5
Lost to Follow-up             1
Other reason was not specified             5
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 41 participants
<40 years 25
Between 40 and 65 years 16
>65 years 0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
37.2  (12.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
9
  22.0%
Male
32
  78.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Subjects
Japan Number Analyzed 41 participants
41
1.Primary Outcome
Title Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For all non-responder imputation (NRI) analyses, subjects with a missing value at a visit were imputed as a non-responder for that visit. Observed cases is based on a total of 40 subjects analyzed (vs. 41 subjects for the study and all other analysis sets) due to 1 subject who discontinued prior to Week 12.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Subjects
Non-responder imputation (NRI), N = 41 30
Last Observation Carried Forward (LOCF), N = 41 30
Observed Cases, N = 40 30
2.Secondary Outcome
Title Number of Subjects Achieving ASAS 20
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on non-responder imputation (NRI), for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Subjects
Week 12 30
Week 24 30
Week 48 32
Week 72 32
Week 96 27
Week 120 21
Final Visit 32
3.Secondary Outcome
Title Number of Subjects Achieving ASAS 50
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Subjects
Week 12 23
Week 24 26
Week 48 26
Week 72 25
Week 96 19
Week 120 17
Final Visit 27
4.Secondary Outcome
Title Number of Subjects Achieving ASAS 70
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Subjects
Week 12 13
Week 24 16
Week 48 18
Week 72 17
Week 96 15
Week 120 13
Final Visit 19
5.Secondary Outcome
Title Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Subjects
Week 12 27
Week 24 26
Week 48 25
Week 72 28
Week 96 22
Week 120 18
Final Visit 29
6.Secondary Outcome
Title Mean Change From Baseline in Patient's Global Assessment of Disease Activity
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: mm on scale
Week 12
-34.6
(-42.80 to -26.33)
Week 24
-37.3
(-45.99 to -28.69)
Week 48
-39.5
(-47.52 to -31.51)
Week 72
-39.7
(-48.14 to -31.32)
Week 96
-37.1
(-45.96 to -28.34)
Week 120
-40.1
(-48.61 to -31.53)
Final Visit
-40.6
(-48.81 to -32.32)
7.Secondary Outcome
Title Mean Change From Baseline in Total Back Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: mm on scale
Week 12
-35.6
(-43.68 to -27.59)
Week 24
-37.0
(-45.05 to -28.85)
Week 48
-38.6
(-46.68 to -30.53)
Week 72
-39.3
(-47.53 to -31.01)
Week 96
-36.4
(-44.33 to -28.40)
Week 120
-39.2
(-46.98 to -31.36)
Final Visit
-40.2
(-47.80 to -32.64)
8.Secondary Outcome
Title Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on last observation carried forward (LOCF).
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: mm on scale
Week 12
-19.4
(-24.49 to -14.34)
Week 24
-20.5
(-25.84 to -15.08)
Week 48
-21.9
(-28.39 to -15.51)
Week 72
-22.2
(-29.44 to -14.89)
Week 96
-22.1
(-28.72 to -15.54)
Week 120
-21.8
(-28.07 to -15.51)
Final Visit
-21.6
(-27.65 to -15.49)
9.Secondary Outcome
Title Mean Change From Baseline in C-Reactive Protein (CRP)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Week 12
-1.2
(-1.60 to -0.83)
Week 24
-1.3
(-1.76 to -0.89)
Week 48
-1.4
(-1.78 to -0.95)
Week 72
-1.3
(-1.74 to -0.83)
Week 96
-1.4
(-1.84 to -0.94)
Week 120
-1.3
(-1.76 to -0.76)
Final Visit
-1.2
(-1.67 to -0.64)
10.Secondary Outcome
Title Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Subjects
Week 12 28
Week 24 29
Week 48 31
Week 72 28
Week 96 25
Week 120 20
Final Visit 29
11.Secondary Outcome
Title Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Subjects
Week 12 26
Week 24 26
Week 48 27
Week 72 28
Week 96 24
Week 120 18
Final Visit 26
12.Secondary Outcome
Title Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Subjects
Week 12 15
Week 24 16
Week 48 17
Week 72 20
Week 96 15
Week 120 13
Final Visit 19
13.Secondary Outcome
Title Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 12
-0.4
(-0.79 to -0.02)
Week 24
-0.5
(-0.90 to -0.17)
Week 48
-0.6
(-1.07 to -0.23)
Week 72
-0.5
(-0.95 to -0.06)
Week 96
-0.6
(-1.03 to -0.13)
Week 120
-0.7
(-1.09 to -0.22)
Final Visit
-0.6
(-1.00 to -0.21)
14.Secondary Outcome
Title Mean Change From Baseline in Chest Expansion
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: cm
Week 12
0.7
(0.30 to 1.03)
Week 24
0.4
(0.16 to 0.66)
Week 48
0.8
(0.40 to 1.17)
Week 72
1.0
(0.56 to 1.46)
Week 96
0.6
(0.19 to 1.11)
Week 120
1.1
(0.55 to 1.72)
Final Visit
1.2
(0.54 to 1.80)
15.Secondary Outcome
Title Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 12
-1.0
(-1.71 to -0.39)
Week 24
-1.1
(-1.76 to -0.53)
Week 48
-1.3
(-1.90 to -0.74)
Week 72
-1.1
(-1.72 to -0.48)
Week 96
-1.4
(-1.98 to -0.85)
Week 120
-1.4
(-1.96 to -0.77)
Final Visit
-1.4
(-1.96 to -0.77)
16.Secondary Outcome
Title Mean Change From Baseline in Nocturnal Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: mm on scale
Week 12
-30.0
(-39.71 to -20.29)
Week 24
-31.7
(-41.92 to -21.54)
Week 48
-35.8
(-45.04 to -26.61)
Week 72
-34.6
(-43.45 to -25.77)
Week 96
-33.4
(-43.14 to -23.69)
Week 120
-35.0
(-44.10 to -25.85)
Final Visit
-35.3
(-44.52 to -26.07)
17.Secondary Outcome
Title Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: SJC
Week 12
-1.1
(-1.91 to -0.38)
Week 24
-1.1
(-1.81 to -0.34)
Week 48
-1.1
(-1.97 to -0.32)
Week 72
-1.3
(-2.17 to -0.37)
Week 96
-1.2
(-1.99 to -0.44)
Week 120
-1.2
(-2.01 to -0.43)
Final Visit
-1.2
(-1.94 to -0.40)
18.Secondary Outcome
Title Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: TJC
Week 12
-1.5
(-3.86 to 0.94)
Week 24
-1.4
(-3.66 to 0.87)
Week 48
-1.3
(-3.60 to 0.96)
Week 72
-1.6
(-4.00 to 0.88)
Week 96
-1.6
(-3.63 to 0.46)
Week 120
-1.6
(-3.69 to 0.56)
Final Visit
-1.6
(-3.69 to 0.56)
19.Secondary Outcome
Title Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on LOCF.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: units on scale
PCS Week 12
9.6
(6.81 to 12.40)
PCS Week 24
10.6
(7.51 to 13.67)
PCS Week 48
11.4
(8.69 to 14.06)
PCS Week 72
11.3
(8.29 to 14.30)
PCS Week 96
12.3
(9.25 to 15.37)
PCS Week 120
12.1
(9.07 to 15.19)
PCS Final Visit
12.6
(9.75 to 15.53)
MCS Week 12
7.0
(3.07 to 10.87)
MCS Week 24
7.0
(3.62 to 10.34)
MCS Week 48
6.1
(2.52 to 9.59)
MCS Week 72
6.7
(2.94 to 10.53)
MCS Week 96
5.8
(2.55 to 9.09)
MCS Week 120
6.1
(2.63 to 9.59)
MCS Final Visit
5.9
(2.44 to 9.42)
Time Frame All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%)
Total   6/41 (14.63%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1/41 (2.44%) 
Eye disorders   
Cataract  2/41 (4.88%) 
Gastrointestinal disorders   
Periodontitis  1/41 (2.44%) 
Infections and infestations   
Intervertebral discitis  1/41 (2.44%) 
Osteomyelitis  1/41 (2.44%) 
Pneumonia  1/41 (2.44%) 
Septic shock  1/41 (2.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1/41 (2.44%) 
Colon cancer  1/41 (2.44%) 
Reproductive system and breast disorders   
Adenomyosis  1/41 (2.44%) 
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adalimumab
Affected / at Risk (%)
Total   41/41 (100.00%) 
Eye disorders   
Cataract  4/41 (9.76%) 
Conjunctivitis allergic  3/41 (7.32%) 
Gastrointestinal disorders   
Diarrhoea  8/41 (19.51%) 
Stomatitis  3/41 (7.32%) 
Nausea  4/41 (9.76%) 
General disorders   
Injection site erythema  6/41 (14.63%) 
Pyrexia  4/41 (9.76%) 
Malaise  3/41 (7.32%) 
Hepatobiliary disorders   
Hepatic function abnormal  9/41 (21.95%) 
Hepatic steatosis  3/41 (7.32%) 
Infections and infestations   
Nasopharyngitis  22/41 (53.66%) 
Upper respiratory tract infection  8/41 (19.51%) 
Pharyngitis  4/41 (9.76%) 
Gastroenteritis  3/41 (7.32%) 
Upper respiratory tract infection  7/41 (17.07%) 
Influenza  4/41 (9.76%) 
Rhinitis  3/41 (7.32%) 
Injury, poisoning and procedural complications   
Contusion  6/41 (14.63%) 
Investigations   
Weight increased  4/41 (9.76%) 
C-reactive protein increased  3/41 (7.32%) 
Metabolism and nutrition disorders   
Hyperlipidaemia  3/41 (7.32%) 
Musculoskeletal and connective tissue disorders   
Ankylosing spondylitis  6/41 (14.63%) 
Back pain  4/41 (9.76%) 
Arthralgia  3/41 (7.32%) 
Myalgia  3/41 (7.32%) 
Nervous system disorders   
Headache  5/41 (12.20%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation  8/41 (19.51%) 
Pharyngolaryngeal pain  3/41 (7.32%) 
Skin and subcutaneous tissue disorders   
Rash  5/41 (12.20%) 
Dermatitis contact  3/41 (7.32%) 
Erythema  3/41 (7.32%) 
Vascular disorders   
Hypertension  3/41 (7.32%) 
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure agreements vary; the Medical Institution shall not disclose any material/information disclosed by Abbott Japan in connection with the Clinical Research or information obtained by conducting the Clinical Research to third parties without Abbott Japan's prior written approval. When Medical Institution intends to publish information obtained by conducting Clinical Research, Institution shall obtain Abbott Japan's prior written approval.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00667355     History of Changes
Other Study ID Numbers: M10-239
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: May 28, 2010
Results First Posted: August 11, 2010
Last Update Posted: January 26, 2012