ClinicalTrials.gov
ClinicalTrials.gov Menu

Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00235833
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : January 29, 2010
Last Update Posted : April 11, 2011
Sponsor:
Collaborators:
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Information provided by:
Abbott

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: adalimumab
Enrollment 25
Recruitment Details Japanese subjects with moderate to severe rheumatoid arthritis (RA) in relatively good physical health excluding RA symptoms and who completed a preceding continuous repeated administration study of adalimumab (DE035X/D2E7-J081-003) who wished to continue treatment until approval of adalimumab in Japan.
Pre-assignment Details  
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Period Title: Overall Study
Started 25
Completed 9
Not Completed 16
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
54.1  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
21
  84.0%
Male
4
  16.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 25 participants
25
1.Primary Outcome
Title Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Hide Description Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts [TJC or SJC, respectively] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity [PGA], [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein [CRP]) at each visit
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on observed data.
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Week 0 ACR20 12
Week 0 ACR50 7
Week 0 ACR70 5
Week 6 ACR20 15
Week 6 ACR50 12
Week 6 ACR70 5
Week 12 ACR20 16
Week 12 ACR50 11
Week 12 ACR70 6
Week 18 ACR20 18
Week 18 ACR50 11
Week 18 ACR70 7
Week 24 ACR20 16
Week 24 ACR50 11
Week 24 ACR70 4
Week 36 ACR20 15
Week 36 ACR50 10
Week 36 ACR70 6
Week 48 ACR20 13
Week 48 ACR50 10
Week 48 ACR70 5
Week 60 ACR20 12
Week 60 ACR50 11
Week 60 ACR70 6
Week 72 ACR20 11
Week 72 ACR50 10
Week 72 ACR70 3
Week 84 ACR20 11
Week 84 ACR50 9
Week 84 ACR70 7
Week 96 ACR20 11
Week 96 ACR50 10
Week 96 ACR70 6
Week 108 ACR20 11
Week 108 ACR50 10
Week 108 ACR70 6
Week 120 ACR20 10
Week 120 ACR50 10
Week 120 ACR70 6
Week 132 ACR20 10
Week 132 ACR50 7
Week 132 ACR70 5
Week 144 ACR20 10
Week 144 ACR50 9
Week 144 ACR70 7
Week 156 ACR20 9
Week 156 ACR50 8
Week 156 ACR70 4
Week 168 ACR20 9
Week 168 ACR50 8
Week 168 ACR70 6
Week 180 ACR20 10
Week 180 ACR50 9
Week 180 ACR70 5
Week 192 ACR20 9
Week 192 ACR50 8
Week 192 ACR70 5
Week 204 ACR20 10
Week 204 ACR50 8
Week 204 ACR70 4
Week 216 ACR20 9
Week 216 ACR50 8
Week 216 ACR70 4
Week 228 ACR20 9
Week 228 ACR50 7
Week 228 ACR70 3
Week 240 ACR20 7
Week 240 ACR50 4
Week 240 ACR70 1
Week 252 ACR20 5
Week 252 ACR50 3
Week 252 ACR70 2
Week 264 ACR20 2
Week 264 ACR50 1
Week 264 ACR70 1
Final Value ACR20 13
Final Value ACR50 11
Final Value ACR70 8
2.Secondary Outcome
Title Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Hide Description Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: TJC
Week 0 -11.2  (14.5)
Week 6 -13.4  (11.2)
Week 12 -16.0  (14.0)
Week 18 -17.5  (12.2)
Week 24 -16.3  (13.7)
Week 36 -17.0  (13.4)
Week 48 -18.1  (13.8)
Week 60 -18.5  (13.2)
Week 72 -18.1  (13.2)
Week 84 -21.9  (13.7)
Week 96 -22.8  (13.6)
Week 108 -21.8  (13.6)
Week 120 -22.7  (14.4)
Week 132 -22.0  (14.5)
Week 144 -21.2  (14.4)
Week 156 -22.1  (14.9)
Week 168 -22.7  (13.6)
Week 180 -22.7  (13.5)
Week 192 -23.3  (14.5)
Week 204 -23.1  (14.7)
Week 216 -23.7  (14.7)
Week 228 -23.4  (14.7)
Week 240 -24.6  (13.7)
Week 252 -26.7  (17.5)
Week 264 -25.0  (7.1)
Final Value -15.8  (13.8)
3.Secondary Outcome
Title Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Hide Description Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: SJC
Week 0 -8.8  (11.0)
Week 6 -11.3  (11.3)
Week 12 -12.0  (12.1)
Week 18 -14.4  (9.6)
Week 24 -13.8  (10.7)
Week 36 -12.4  (6.8)
Week 48 -14.9  (6.3)
Week 60 -14.8  (5.7)
Week 72 -14.5  (6.5)
Week 84 -13.5  (4.7)
Week 96 -13.9  (5.8)
Week 108 -13.8  (5.7)
Week 120 -13.2  (4.5)
Week 132 -13.2  (4.2)
Week 144 -14.0  (3.9)
Week 156 -13.3  (4.3)
Week 168 -13.2  (5.5)
Week 180 -13.7  (4.4)
Week 192 -13.4  (4.9)
Week 204 -12.9  (5.3)
Week 216 -12.6  (5.8)
Week 228 -12.9  (5.5)
Week 240 -11.8  (5.8)
Week 252 -11.8  (5.8)
Week 264 -12.0  (8.5)
Final Value -10.1  (11.8)
4.Secondary Outcome
Title Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Hide Description Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mm on scale
Week 0 -27.0  (28.6)
Week 6 -34.5  (28.4)
Week 12 -40.7  (22.0)
Week 18 -42.2  (22.1)
Week 24 -41.3  (24.2)
Week 36 -34.3  (19.9)
Week 48 -40.7  (21.7)
Week 60 -39.2  (27.8)
Week 72 -39.2  (26.7)
Week 84 -40.1  (29.8)
Week 96 -51.7  (20.9)
Week 108 -50.6  (20.6)
Week 120 -50.5  (27.3)
Week 132 -50.1  (21.1)
Week 144 -43.6  (28.1)
Week 156 -47.2  (28.9)
Week 168 -49.5  (25.6)
Week 180 -51.8  (24.4)
Week 192 -49.6  (26.7)
Week 204 -47.5  (22.7)
Week 216 -52.5  (22.8)
Week 228 -49.5  (23.2)
Week 240 -47.3  (18.9)
Week 252 -51.7  (23.5)
Week 264 -35.5  (38.9)
Final Value -31.2  (32.7)
5.Secondary Outcome
Title Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Hide Description Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mm on scale
Week 0 -21.7  (27.4)
Week 6 -29.5  (25.8)
Week 12 -33.3  (25.8)
Week 18 -35.1  (25.7)
Week 24 -35.6  (22.2)
Week 36 -33.0  (24.5)
Week 48 -38.3  (24.3)
Week 60 -38.7  (26.4)
Week 72 -39.3  (24.9)
Week 84 -37.1  (30.3)
Week 96 -42.9  (26.0)
Week 108 -35.1  (31.0)
Week 120 -40.4  (26.2)
Week 132 -34.1  (21.3)
Week 144 -37.3  (26.4)
Week 156 -34.5  (31.1)
Week 168 -37.2  (26.3)
Week 180 -36.1  (20.4)
Week 192 -35.3  (26.1)
Week 204 -35.0  (18.0)
Week 216 -30.3  (23.9)
Week 228 -30.7  (27.6)
Week 240 -23.9  (22.4)
Week 252 -25.0  (21.2)
Week 264 -19.5  (10.6)
Final Value -20.0  (27.9)
6.Secondary Outcome
Title Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Hide Description Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mm on scale
Week 0 -13.7  (31.6)
Week 6 -23.1  (24.7)
Week 12 -27.2  (27.3)
Week 18 -29.1  (28.2)
Week 24 -30.6  (20.2)
Week 36 -26.2  (28.2)
Week 48 -32.7  (22.2)
Week 60 -33.4  (26.1)
Week 72 -33.4  (24.2)
Week 84 -32.9  (26.7)
Week 96 -37.6  (22.7)
Week 108 -31.8  (27.6)
Week 120 -35.0  (21.9)
Week 132 -30.0  (18.6)
Week 144 -33.1  (24.1)
Week 156 -29.9  (31.0)
Week 168 -31.8  (24.0)
Week 180 -32.8  (19.8)
Week 192 -31.0  (23.4)
Week 204 -30.6  (17.4)
Week 216 -24.4  (23.7)
Week 228 -26.5  (26.8)
Week 240 -24.9  (23.7)
Week 252 -20.3  (24.4)
Week 264 -7.0  (2.8)
Final Value -14.4  (29.6)
7.Secondary Outcome
Title Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Hide Description Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire [HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).], a component the of ACR criteria, by visit
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 -0.41  (0.77)
Week 6 -0.48  (0.64)
Week 12 -0.47  (0.65)
Week 18 -0.50  (0.72)
Week 24 -0.49  (0.76)
Week 36 -0.43  (0.77)
Week 48 -0.63  (0.72)
Week 60 -0.66  (0.81)
Week 72 -0.73  (0.81)
Week 84 -0.82  (0.71)
Week 96 -0.80  (0.71)
Week 108 -0.74  (0.83)
Week 120 -0.73  (0.81)
Week 132 -0.63  (0.80)
Week 144 -0.63  (0.80)
Week 156 -0.58  (0.69)
Week 168 -0.64  (0.78)
Week 180 -0.63  (0.70)
Week 192 -0.49  (0.73)
Week 204 -0.51  (0.67)
Week 216 -0.51  (0.77)
Week 228 -0.49  (0.93)
Week 240 -0.36  (0.70)
Week 252 -0.25  (0.80)
Week 264 0.25  (1.41)
Final Value -0.31  (0.77)
8.Secondary Outcome
Title Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Hide Description Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein [CRP; mg/dL], a component of the ACR criteria, by visit.
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0 -0.92  (2.64)
Week 6 -2.30  (2.73)
Week 12 -2.49  (3.55)
Week 18 -2.11  (3.22)
Week 24 -2.62  (2.49)
Week 36 -2.42  (3.17)
Week 48 -2.94  (3.37)
Week 60 -3.31  (3.15)
Week 72 -3.05  (3.35)
Week 84 -2.84  (3.50)
Week 96 -3.37  (3.08)
Week 108 -3.07  (3.09)
Week 120 -3.16  (3.62)
Week 132 -3.23  (3.39)
Week 144 -3.14  (3.66)
Week 156 0.01  (10.96)
Week 168 -3.47  (3.42)
Week 180 -3.49  (3.28)
Week 192 -3.21  (3.42)
Week 204 -3.30  (3.22)
Week 216 -2.90  (2.57)
Week 228 -2.93  (2.57)
Week 240 -1.71  (6.10)
Week 252 -1.89  (3.56)
Week 264 -4.16  (5.35)
Final Value -1.14  (4.23)
9.Secondary Outcome
Title Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Hide Description Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts [TJC or SJC, respectively] and 20% improvement in 3 of the following 5 criteria: [1] Physician's global assessment (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein (CRP)
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Weeks
Week 0 - Week 6 3.2  (2.7)
Week 0 - Week 12 7.0  (5.5)
Week 0 - Week 18 11.0  (8.0)
Week 0 - Week 24 15.1  (10.6)
Week 0 - Week 36 22.6  (15.9)
Week 0 - Week 48 29.3  (21.1)
Week 0 - Week 60 35.3  (26.3)
Week 0 - Week 72 40.8  (31.3)
Week 0 - Week 84 46.1  (36.2)
Week 0 - Week 96 51.4  (41.3)
Week 0 - Week 108 56.6  (46.7)
Week 0 - Week 120 61.7  (52.0)
Week 0 - Week 132 66.5  (57.2)
Week 0 - Week 144 71.3  (62.5)
Week 0 - Week 156 75.8  (67.7)
Week 0 - Week 168 80.2  (72.7)
Week 0 - Week 180 84.7  (78.0)
Week 0 - Week 192 89.3  (83.4)
Week 0 - Week 204 93.8  (88.2)
Week 0 - Week 216 98.4  (92.7)
Week 0 - Week 228 102.7  (97.1)
Week 0 - Week 240 106.6  (101.0)
Week 0 - Week 252 109.4  (104.2)
Week 0 - Week 264 111.1  (106.4)
10.Secondary Outcome
Title Number of Subjects With Morning Stiffness at Each Visit
Hide Description The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).
Time Frame Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects analyzed (as-observed) include only those who had morning stiffness at baseline.
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description:
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Week 0 16
Week 6 15
Week 12 11
Week 18 11
Week 24 9
Week 36 10
Week 48 6
Week 60 5
Week 72 7
Week 84 6
Week 96 4
Week 108 4
Week 120 3
Week 132 3
Week 144 3
Week 156 3
Week 168 2
Week 180 2
Week 192 3
Week 204 4
Week 216 3
Week 228 3
Week 240 3
Week 252 2
Week 264 1
Final Value 15
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab 40 mg Eow
Hide Arm/Group Description Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
All-Cause Mortality
Adalimumab 40 mg Eow
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab 40 mg Eow
Affected / at Risk (%)
Total   10/25 (40.00%) 
Blood and lymphatic system disorders   
Lymphadenitis  1/25 (4.00%) 
Cardiac disorders   
Brugada syndrome  1/25 (4.00%) 
General disorders   
Pyrexia  1/25 (4.00%) 
Infections and infestations   
Pyelonephritis  1/25 (4.00%) 
Sepsis  1/25 (4.00%) 
Injury, poisoning and procedural complications   
Tendon rupture  1/25 (4.00%) 
Investigations   
C-reactive protein increased  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1/25 (4.00%) 
Rheumatoid arthritis  3/25 (12.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to lymph nodes  1/25 (4.00%) 
Non-Hodgkin's Lymphoma  1/25 (4.00%) 
Ovarian neoplasm  1/25 (4.00%) 
Rectal cancer  1/25 (4.00%) 
Renal and urinary disorders   
Calculus ureteric  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation  1/25 (4.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adalimumab 40 mg Eow
Affected / at Risk (%)
Total   25/25 (100.00%) 
Gastrointestinal disorders   
Diarrhoea  6/25 (24.00%) 
Dental caries  3/25 (12.00%) 
Gastritis  3/25 (12.00%) 
Vomiting  3/25 (12.00%) 
Enterocolitis  2/25 (8.00%) 
Nausea  2/25 (8.00%) 
Periodontitis  2/25 (8.00%) 
General disorders   
Adverse drug reaction  4/25 (16.00%) 
Chest pain  2/25 (8.00%) 
Injection site reaction  2/25 (8.00%) 
Hepatobiliary disorders   
Hepatic function abnormal  4/25 (16.00%) 
Infections and infestations   
Nasopharyngitis  15/25 (60.00%) 
Cystitis  4/25 (16.00%) 
Gastroenteritis  3/25 (12.00%) 
Bronchitis  2/25 (8.00%) 
Herpes zoster  2/25 (8.00%) 
Pharyngitis  2/25 (8.00%) 
Rhinitis  2/25 (8.00%) 
Sinusitis  2/25 (8.00%) 
Tinea blanca  2/25 (8.00%) 
Tinea pedis  2/25 (8.00%) 
Upper respiratory tract infection  2/25 (8.00%) 
Injury, poisoning and procedural complications   
Contusion  4/25 (16.00%) 
Arthropod sting  3/25 (12.00%) 
Animal bite  2/25 (8.00%) 
Fall  2/25 (8.00%) 
Wound  2/25 (8.00%) 
Investigations   
Blood glucose increased  3/25 (12.00%) 
DNA antibody positive  3/25 (12.00%) 
Blood alkaline phosphatase increased  2/25 (8.00%) 
Blood triglycerides increased  2/25 (8.00%) 
Lymphocyte percentage decreased  2/25 (8.00%) 
Metabolism and nutrition disorders   
Hyperuricaemia  2/25 (8.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  4/25 (16.00%) 
Nervous system disorders   
Dizziness  3/25 (12.00%) 
Psychiatric disorders   
Insomnia  4/25 (16.00%) 
Respiratory, thoracic and mediastinal disorders   
Rhinorrhoea  4/25 (16.00%) 
Cough  3/25 (12.00%) 
Upper respiratory tract inflammation  3/25 (12.00%) 
Nasal congestion  2/25 (8.00%) 
Pharyngolaryngeal discomfort  2/25 (8.00%) 
Pharyngolaryngeal pain  2/25 (8.00%) 
Productive cough  2/25 (8.00%) 
Skin and subcutaneous tissue disorders   
Pruritus  5/25 (20.00%) 
Eczema  4/25 (16.00%) 
Rash  4/25 (16.00%) 
Erythema  3/25 (12.00%) 
Haemorrhage subcutaneous  3/25 (12.00%) 
Rash erythematous  3/25 (12.00%) 
Urticaria  3/25 (12.00%) 
Dermatitis contact  2/25 (8.00%) 
Hyperkeratosis  2/25 (8.00%) 
Vascular disorders   
Hypertension  2/25 (8.00%) 
Due to the small population, statistical tests were not performed.
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; most restrictive agreement states Medical Institution shall not disclose materials/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 the Clinical Research, Medical Institution shall obtain Abbott Japan's prior written approval.
Results Point of Contact
Name/Title: Medical Information Specialist
Organization: Abbott
Phone: 800-633-9110
Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00235833     History of Changes
Other Study ID Numbers: M02-564
First Submitted: October 7, 2005
First Posted: October 12, 2005
Results First Submitted: October 12, 2009
Results First Posted: January 29, 2010
Last Update Posted: April 11, 2011