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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: NCT00235872
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : January 13, 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 309
Recruitment Details  
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 309
Completed 162
Not Completed 147
Reason Not Completed
Adverse Event             34
Death             1
Lost to Follow-up             1
Withdrawal by Subject             50
Administrative reason             61
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 309
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 309 participants
< 40 years 35
Between 40 and 49 years 57
Between 50 and 59 years 111
>/= 60 years 106
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 309 participants
Female
249
  80.6%
Male
60
  19.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 309 participants
309
1.Primary Outcome
Title Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Hide Description Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, 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 (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Measure Type: Number
Unit of Measure: participants
Week 0 ACR20 104
Week 0 ACR50 52
Week 0 ACR70 22
Week 4 ACR20 157
Week 4 ACR50 74
Week 4 ACR70 30
Week 8 ACR20 154
Week 8 ACR50 74
Week 8 ACR70 40
Week 12 ACR20 154
Week 12 ACR50 83
Week 12 ACR70 39
Week 16 ACR20 148
Week 16 ACR50 81
Week 16 ACR70 46
Week 20 ACR20 155
Week 20 ACR50 77
Week 20 ACR70 46
Week 24 ACR20 155
Week 24 ACR50 91
Week 24 ACR70 46
Week 36 ACR20 163
Week 36 ACR50 99
Week 36 ACR70 50
Week 48 ACR20 158
Week 48 ACR50 99
Week 48 ACR70 52
Week 60 ACR20 141
Week 60 ACR50 86
Week 60 ACR70 47
Week 72 ACR20 118
Week 72 ACR50 75
Week 72 ACR70 45
Week 84 ACR20 92
Week 84 ACR50 63
Week 84 ACR70 33
Week 96 ACR20 81
Week 96 ACR50 49
Week 96 ACR70 24
Week 108 ACR20 72
Week 108 ACR50 43
Week 108 ACR70 27
Week 120 ACR20 63
Week 120 ACR50 41
Week 120 ACR70 23
Week 132 ACR20 68
Week 132 ACR50 49
Week 132 ACR70 27
Week 144 ACR20 63
Week 144 ACR50 47
Week 144 ACR70 25
Week 156 ACR20 61
Week 156 ACR50 47
Week 156 ACR70 27
Week 168 ACR20 62
Week 168 ACR50 42
Week 168 ACR70 28
Week 180 ACR20 47
Week 180 ACR50 33
Week 180 ACR70 16
Week 192 ACR20 24
Week 192 ACR50 16
Week 192 ACR70 8
Week 204 ACR20 8
Week 204 ACR50 7
Week 204 ACR70 4
Week 216 ACR20 1
Week 216 ACR50 1
Week 216 ACR70 0
Final Value ACR20 166
Final Value ACR50 104
Final Value ACR70 58
2.Secondary Outcome
Title Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
Hide Description Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: TJC
TJC Baseline (n=309) 22.3  (11.59)
TJC Week 0 (n=309) -7.2  (10.10)
TJC Week 4 (n=307) -10.0  (10.10)
TJC Week 8 (n=304) -10.6  (10.37)
TJC Week 12 (n=298) -11.0  (10.70)
TJC Week 16 (n=287) -11.5  (10.88)
TJC Week 20 (n=271) -12.3  (10.84)
TJC Week 24 (n=261) -13.3  (10.72)
TJC Week 36 (n=245) -14.3  (10.43)
TJC Week 48(n=232) -14.9  (10.88)
TJC Week 60 (n=209) -15.4  (10.75)
TJC Week 72 (n=162) -15.9  (10.86)
TJC Week 84 (n=125) -16.0  (10.27)
TJC Week 96 (n=102) -16.0  (9.74)
TJC Week 108 (n=95) -16.0  (9.49)
TJC Week 120 (n=91) -15.9  (9.42)
TJC Week 132 (n=90) -16.1  (10.00)
TJC Week 144 (n=87) -16.4  (10.15)
TJC Week 156(n=82) -16.2  (11.63)
TJC Week 168 (n=78) -17.7  (10.43)
TJC Week 180 (n=59) -17.7  (11.39)
TJC Week 192 (n=33) -17.8  (11.75)
TJC Week 204 (n=9) -22.4  (8.50)
TJC Week 216 (n=1) -24.0  (0)
TJC Final Value (n=309) -12.5  (12.36)
3.Secondary Outcome
Title Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Hide Description Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: SJC
Baseline (n=309) 17.6  (8.26)
Week 0 (n=309) -6.1  (7.69)
Week 4 (n=307) -8.5  (7.72)
Week 8 (n=304) -8.6  (8.31)
Week 12 (n=298) -9.0  (8.09)
Week 16 (n=287) -9.0  (8.08)
Week 20 (n=271) -10.1  (7.88)
Week 24 (n=261) -10.9  (7.91)
Week 36 (n=245) -11.7  (7.83)
Week 48 (n=232) -11.9  (8.20)
Week 60 (n=209) -12.2  (8.50)
Week 72 (n=162) -12.8  (8.20)
Week 84 (n=125) -13.7  (7.73)
Week 96 (n=102) -13.6  (7.50)
Week 108 (n=95) -13.5  (7.68)
Week 120 (n=91) -13.8  (7.75)
Week 132 (n=90) -13.8  (8.17)
Week 144 (n=87) -14.3  (7.44)
Week 156 (n=82) -14.0  (7.76)
Week 168 (n=72) -14.7  (7.89)
Week 180 (n=59) -15.3  (7.76)
Week 192 (n=33) -17.5  (8.30)
Week 204 (n=9) -20.0  (4.97)
Week 216 (n=1) -86.0  (0)
Final Value (n=309) -10.6  (8.93)
4.Secondary Outcome
Title Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Hide Description Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: mm on a scale
Baseline (n=309) 67.2  (19.67)
Week 0 (n=309) -20.0  (25.83)
Week 4 (n=307) -27.9  (25.80)
Week 8 (n=304) -28.1  (26.69)
Week 12 (n=298) -28.3  (26.54)
Week 16 (n=286) -29.9  (26.26)
Week 20 (n=271) -33.1  (25.59)
Week 24 (n=261) -35.1  (25.85)
Week 36 (n=245) -37.3  (24.76)
Week 48 (n=232) -37.8  (25.08)
Week 60 (n=209) -38.1  (25.75)
Week 72 (n=162) -39.6  (24.97)
Week 84 (n=125) -43.1  (23.43)
Week 96 (n=102) -42.8  (22.35)
Week 108 (n=94) -43.6  (23.47)
Week 120 (n=91) -42.2  (24.68)
Week 132 (n=90) -42.9  (24.79)
Week 144 (n=87) -42.3  (23.80)
Week 156 (n=82) -44.3  (23.73)
Week 168 (n=78) -45.6  (23.23)
Week 180 (n=59) -45.0  (26.12)
Week 192 (n=33) -46.1  (26.10)
Week 204 (n=9) -60.1  (15.52)
Week 216 (n=1) -64.0  (0)
Final Value (n=309) -30.2  (30.04)
5.Secondary Outcome
Title Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Hide Description Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: mm on unit scale
Baseline (n=309) 63.5  (24.00)
Week 0 (n=309) -14.2  (26.93)
Week 4 (n=307) -19.4  (28.30)
Week 8 (n=304) -19.8  (28.22)
Week 12 (n=298) -21.1  (28.62)
Week 16 (n=287) -21.0  (28.63)
Week 20 (n=271) -23.0  (29.14)
Week 24 (n=261) -23.9  (29.06)
Week 36 (n=244) -26.9  (29.38)
Week 48 (n=231) -27.3  (28.77)
Week 60 (n=209) -28.2  (29.86)
Week 72 (n=162) -29.4  (27.90)
Week 84 (n=125) -30.4  (29.49)
Week 96 (n=102) -31.7  (25.73)
Week 108 (n=95) -28.0  (27.73)
Week 120 (n=90) -27.9  (26.64)
Week 132 (n=90) -29.2  (27.73)
Week 144 (n=87) -28.6  (29.54)
Week 156 (n=82) -29.7  (28.72)
Week 168 (n=78) -29.7  (30.14)
Week 180 (n=59) -30.1  (30.45)
Week 192 (n=33) -22.3  (32.92)
Week 204 (n=8) -48.1  (30.98)
Week 216 (n=1) -85.0  (0)
Final Value (n=309) -20.7  (31.77)
6.Secondary Outcome
Title Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Hide Description Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: mm on unit scale
Baseline (n=309) 61.3  (24.03)
Week 0 (n=309) -12.3  (27.64)
Week 4 (n=307) -17.0  (28.65)
Week 8 (n=304) -17.7  (27.78)
Week 12 (n=298) -19.1  (27.66)
Week 16 (n=287) -19.6  (27.42)
Week 20 (n=271) -22.2  (27.87)
Week 24 (n=261) -22.7  (27.00)
Week 36 (n=244) -26.0  (27.55)
Week 48 (n=231) -26.5  (28.11)
Week 60 (n=209) -27.1  (28.53)
Week 72 (n=162) -28.6  (26.56)
Week 84 (n=125) -28.1  (28.65)
Week 96 (n=102) -30.0  (24.27)
Week 108 (n=95) -28.6  (24.40)
Week 120 (n=90) -26.3  (25.26)
Week 132 (n=90) -28.5  (27.13)
Week 144 (n=87) -27.6  (27.98)
Week 156 (n=82) -29.7  (26.65)
Week 168 (n=78) -29.4  (27.62)
Week 180 (n=59) -29.9  (25.63)
Week 192 (n=33) -23.5  (29.13)
Week 204 (n=9) -39.7  (30.54)
Week 216 (n=1) -86.0  (0)
Final Value (n=309) -20.1  (31.24)
7.Secondary Outcome
Title Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Hide Description Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm 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 of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: mm on a scale
Baseline (n=309) 1.5  (0.75)
Week 0 (n=309) -0.2  (0.49)
Week 4 (n=307) -0.3  (0.53)
Week 8 (n=304) -0.3  (0.51)
Week 12 (n=298) -0.3  (0.53)
Week 16 (n=287) -0.3  (0.54)
Week 20 (n=271) -0.3  (0.56)
Week 24 (n=261) -0.4  (0.53)
Week 36 (n=244) -0.4  (0.58)
Week 48 (n=231) -0.4  (0.56)
Week 60 (n=209) -0.5  (0.57)
Week 72 (n=162) -0.5  (0.52)
Week 84 (n=125) -0.5  (0.59)
Week 96 (n=102) -0.5  (0.58)
Week 108 (n=95) -0.5  (0.55)
Week 120 (n=90) -0.4  (0.62)
Week 132 (n=90) -0.5  (0.58)
Week 144 (n=87) -0.5  (0.57)
Week 156 (n=82) -0.5  (0.58)
Week 168 (n=78) -0.6  (0.56)
Week 180 (n=59) -0.5  (0.59)
Week 192 (n=33) -0.5  (0.55)
Week 204 (n=9) -0.7  (0.48)
Week 216 (n=1) -1.4  (0)
Final Visit (n=309) -0.3  (0.62)
8.Secondary Outcome
Title Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Hide Description Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=-309) 4.7  (3.30)
Week 0 (n=309) -1.2  (3.02)
Week 4 (n=307) -1.7  (3.38)
Week 8 (n=303) -1.6  (3.69)
Week 12 (n=298) -1.5  (3.33)
Week 16 (n=287) -1.6  (3.58)
Week 20 (n=271) -1.8  (3.60)
Week 24 (n=261) -1.9  (3.51)
Week 36 (n=245) -2.2  (3.55)
Week 48 (n=231) -2.3  (3.66)
Week 60 (n=209) -2.5  (3.46)
Week 72 (n=162) -2.4  (3.77)
Week 84 (n=125) -2.9  (3.90)
Week 96 (n=102) -3.3  (3.59)
Week 108 (n=95) -3.1  (3.63)
Week 120 (n=91) -2.7  (4.02)
Week 132 (n=90) -3.3  (3.45)
Week 144 (n=87) -3.3  (3.37)
Week 156 (n=82) -3.5  (3.57)
Week 168 (n=78) -3.4  (3.89)
Week 180 (n=58) -3.2  (4.55)
Week 192 (n=33) -4.2  (4.21)
Week 204 (n=9) -5.4  (6.38)
Week 216 (n=1) -4.0  (0)
Final Value (n=309) -1.7  (4.01)
9.Secondary Outcome
Title Presence of Morning Stiffness
Hide Description The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Measure Type: Number
Unit of Measure: participants
Week 0 182
Week 4 173
Week 8 168
Week 12 167
Week 16 154
Week 20 148
Week 24 138
Week 36 106
Week 48 93
Week 60 91
Week 72 68
Week 84 47
Week 96 39
Week 108 29
Week 120 29
Week 132 29
Week 144 32
Week 156 20
Week 168 19
Week 180 16
Week 192 11
Week 204 1
Week 216 0
Final Value 141
10.Secondary Outcome
Title Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Hide Description Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline (n=246) 221.8  (374.72)
Week 0 (n=182) -48.9  (292.93)
Week 4 (n=173) -64.2  (307.03)
Week 8 (n=168) -69.4  (387.21)
Week 12 (n=167) -79.7  (348.20)
Week 16 (n=154) -64.0  (338.37)
Week 20 (n=148) -87.9  (318.04)
Week 24 (n=138) -104.9  (293.66)
Week 36 (n=106) -79.9  (287.89)
Week 48 (n=93) -86.5  (281.83)
Week 60 (n=91) -95.0  (363.90)
Week 72 (n=68) -86.4  (247.30)
Week 84 (n=47) -30.5  (145.23)
Week 96 (n=39) -95.6  (248.27)
Week 108 (n=29) -97.4  (263.44)
Week 120 (n=29) -94.8  (278.36)
Week 132 (n=29) -116.9  (279.96)
Week 144 (n=32) -34.2  (372.50)
Week 156 (n=20) -46.3  (169.08)
Week 168 (n=19) -138.0  (338.26)
Week 180 (n=16) -98.8  (139.98)
Week 192 (n=11) -47.7  (113.65)
Week 204 (n=1) 30.0  (0)
Final Value (n=238) -57.9  (358.24)
11.Secondary Outcome
Title Presence of Rheumatoid Factor (RF)
Hide Description The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Measure Type: Number
Unit of Measure: participants
Week 24 248
Week 48 191
Week 72 142
Week 96 92
Week 120 69
Week 144 66
Week 168 60
Week 192 31
Week 216 1
Final Value 250
12.Secondary Outcome
Title Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Hide Description Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. 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 309
Mean (Standard Deviation)
Unit of Measure: IU/mL
Baseline (n=308) 293.7  (412.95)
Week 24 (n=308) -37.6  (303.19)
Week 48 (n=243) -82.1  (322.10)
Week 72 (n=185) -104.2  (286.58)
Week 96 (n=112) -59.7  (445.83)
Week 120 (n=93) -101.0  (344.41)
Week 144 (n=88) -111.1  (374.58)
Week 168 (n=80) -139.1  (357.30)
Week 192 (n=41) -143.0  (428.18)
Week 216 (n=4) -76.0  (128.47)
Fina Value (n=308) -55.9  (338.06)
Time Frame Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
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   111/309 (35.92%) 
Blood and lymphatic system disorders   
Anemia * 1  2/309 (0.65%) 
Splenic haemorrhage * 1  1/309 (0.32%) 
Splenic infarction * 1  1/309 (0.32%) 
Cardiac disorders   
Cardiac failure * 1  1/309 (0.32%) 
Cardiac tamponade * 1  1/309 (0.32%) 
Congestive cardiomyopathy * 1  1/309 (0.32%) 
Coronary artery disease * 1  1/309 (0.32%) 
Palpitations * 1  1/309 (0.32%) 
Pericarditis * 1  1/309 (0.32%) 
Congenital, familial and genetic disorders   
Dermoid cyst of ovary * 1  1/309 (0.32%) 
Spondylolisthesis * 1  1/309 (0.32%) 
Ear and labyrinth disorders   
Deafness neurosensory * 1  1/309 (0.32%) 
Vertigo positional * 1  1/309 (0.32%) 
Eye disorders   
Cataract * 1  1/309 (0.32%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/309 (0.32%) 
Abdominal pain upper * 1  1/309 (0.32%) 
Abdominal tenderness * 1  1/309 (0.32%) 
Anal fistula * 1  1/309 (0.32%) 
Colonic polyp * 1  2/309 (0.65%) 
Diarrhoea * 1  1/309 (0.32%) 
Enterocolitis * 1  1/309 (0.32%) 
Gastrointestinal haemorrhage * 1  1/309 (0.32%) 
Hemorrhoids * 1  1/309 (0.32%) 
Ileus paralytic * 1  1/309 (0.32%) 
Nausea * 1  2/309 (0.65%) 
Oesophageal ulcer * 1  1/309 (0.32%) 
Vomiting * 1  1/309 (0.32%) 
General disorders   
Chest discomfort * 1  1/309 (0.32%) 
Injection site erythema * 1  1/309 (0.32%) 
Malaise * 1  1/309 (0.32%) 
Pyrexia * 1  3/309 (0.97%) 
Immune system disorders   
Secondary amyloidosis * 1  1/309 (0.32%) 
Infections and infestations   
Abscess * 1  1/309 (0.32%) 
Arthritis bacterial * 1  2/309 (0.65%) 
Atypical mycobacterial infection * 1  2/309 (0.65%) 
Bronchiectasis * 1  1/309 (0.32%) 
Bronchitis * 1  4/309 (1.29%) 
Cellulitis * 1  4/309 (1.29%) 
Chronic sinusitis * 1  1/309 (0.32%) 
Entertis infectious * 1  1/309 (0.32%) 
Femur fracture * 1  1/309 (0.32%) 
Gastroenteritis * 1  1/309 (0.32%) 
Herpes ophthalmic * 1  1/309 (0.32%) 
Herpes zoster * 1  4/309 (1.29%) 
Lung infection * 1  1/309 (0.32%) 
Osteomyelitis * 1  1/309 (0.32%) 
Pneumonia * 1  7/309 (2.27%) 
Pneumonia bacterial * 1  2/309 (0.65%) 
Pneumonia staphylococcal * 1  1/309 (0.32%) 
Pulmonary tuberculosis * 1  2/309 (0.65%) 
Pyelonephritis * 1  2/309 (0.65%) 
Pyelonephritis acute * 1  3/309 (0.97%) 
Pyothorax * 1  2/309 (0.65%) 
Scapula fracture * 1  1/309 (0.32%) 
Sepsis * 1  1/309 (0.32%) 
Staphylococcal bacteremia * 1  1/309 (0.32%) 
Staphylococcal infection * 1  1/309 (0.32%) 
Urinary tract infection * 1  1/309 (0.32%) 
Endocarditis * 1  1/309 (0.32%) 
Injury, poisoning and procedural complications   
Femoral neck fracture * 1  1/309 (0.32%) 
Forearm fracture * 1  1/309 (0.32%) 
Medical device complication * 1  1/309 (0.32%) 
Patella fracture * 1  1/309 (0.32%) 
Postoperative wound complication * 1  1/309 (0.32%) 
Rib fracture * 1  1/309 (0.32%) 
Spinal compression fracture * 1  5/309 (1.62%) 
Tendon rupture * 1  4/309 (1.29%) 
Investigations   
Blood Beta-D-Glucan increased * 1  1/309 (0.32%) 
C-reactive protein increased * 1  1/309 (0.32%) 
Chest x-ray abnormal * 1  1/309 (0.32%) 
Computerised tomogram abnormal * 1  1/309 (0.32%) 
Hepatic enzyme increased * 1  1/309 (0.32%) 
Weight decreased * 1  1/309 (0.32%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/309 (0.32%) 
Diabetes mellitus * 1  1/309 (0.32%) 
Foot deformity * 1  1/309 (0.32%) 
Hypoalbuminemia * 1  1/309 (0.32%) 
Lumbar spinal stenosis * 1  2/309 (0.65%) 
Musculoskeletal stiffness * 1  1/309 (0.32%) 
Osteoarthritis * 1  2/309 (0.65%) 
Osteonecrosis * 1  1/309 (0.32%) 
Type 2 diabetes mellitus * 1  1/309 (0.32%) 
Musculoskeletal and connective tissue disorders   
Atlantoaxial instability * 1  2/309 (0.65%) 
Hand deformity * 1  1/309 (0.32%) 
Joint destruction * 1  12/309 (3.88%) 
Mobility decreased * 1  1/309 (0.32%) 
Rheumatoid arthritis * 1  25/309 (8.09%) 
Spinal osteoarthritis * 1  2/309 (0.65%) 
Synovial cyst * 1  4/309 (1.29%) 
Systemic lupus erythematosus * 1  1/309 (0.32%) 
Tendon disorder * 1  1/309 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cervix carcinoma * 1  1/309 (0.32%) 
Gastric cancer * 1  1/309 (0.32%) 
Hodgkin's disease * 1  1/309 (0.32%) 
Large intestine carcinoma * 1  1/309 (0.32%) 
Neurilemmoma benign * 1  1/309 (0.32%) 
Ovarian neoplasm * 1  1/309 (0.32%) 
Uterine leiomyoma * 1  1/309 (0.32%) 
Nervous system disorders   
Cerebral hemorrhage * 1  3/309 (0.97%) 
Cerebral infarction * 1  2/309 (0.65%) 
Cerebral ischaemia * 1  1/309 (0.32%) 
Cervical cord compression * 1  1/309 (0.32%) 
Cervical myelopathy * 1  1/309 (0.32%) 
Headache * 1  1/309 (0.32%) 
Lacunar infarction * 1  1/309 (0.32%) 
Myelopathy * 1  1/309 (0.32%) 
Nervous system disorder * 1  1/309 (0.32%) 
Radiculopathy * 1  1/309 (0.32%) 
Subarachnoid hemorrhage * 1  2/309 (0.65%) 
Transient ischaemic attack * 1  1/309 (0.32%) 
Psychiatric disorders   
Decreased activity * 1  1/309 (0.32%) 
Renal and urinary disorders   
Calculus ureteric * 1  1/309 (0.32%) 
Calculus urinary * 1  1/309 (0.32%) 
Renal failure chronic * 1  1/309 (0.32%) 
Renal infarct * 1  1/309 (0.32%) 
Reproductive system and breast disorders   
Haemorrhagic ovarian cyst * 1  1/309 (0.32%) 
Parovarian cyst * 1  1/309 (0.32%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/309 (0.32%) 
Cough * 1  1/309 (0.32%) 
Cryptogenic organizing pneumonia * 1  1/309 (0.32%) 
Interstitial lung disease * 1  2/309 (0.65%) 
Middle lobe syndrome * 1  1/309 (0.32%) 
Pleural effusion * 1  1/309 (0.32%) 
Pleurisy * 1  2/309 (0.65%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  1/309 (0.32%) 
Erythema * 1  1/309 (0.32%) 
Rash * 1  2/309 (0.65%) 
Skin ulcer * 1  3/309 (0.97%) 
Vascular disorders   
Deep vein thrombosis * 1  2/309 (0.65%) 
Peripheral artery aneurysm * 1  1/309 (0.32%) 
Vasodilatation * 1  1/309 (0.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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   285/309 (92.23%) 
Blood and lymphatic system disorders   
Anaemia * 1  16/309 (5.18%) 
Iron deficiency anemia * 1  21/309 (6.80%) 
Gastrointestinal disorders   
Abdominal pain upper * 1  17/309 (5.50%) 
Constipation * 1  42/309 (13.59%) 
Dental caries * 1  24/309 (7.77%) 
Diarrhoea * 1  30/309 (9.71%) 
Gastritis * 1  17/309 (5.50%) 
Nausea * 1  24/309 (7.77%) 
Stomatitis * 1  21/309 (6.80%) 
General disorders   
Adverse drug reaction * 1  73/309 (23.62%) 
Injection site erythema * 1  30/309 (9.71%) 
Injection site reaction * 1  25/309 (8.09%) 
Oedema peripheral * 1  19/309 (6.15%) 
Pyrexia * 1  26/309 (8.41%) 
Infections and infestations   
Bronchitis * 1  37/309 (11.97%) 
Gastroenteritis * 1  16/309 (5.18%) 
Influenza * 1  17/309 (5.50%) 
Nasopharyngitis * 1  139/309 (44.98%) 
Pharyngitis * 1  27/309 (8.74%) 
Upper respiratory tract infection * 1  36/309 (11.65%) 
Injury, poisoning and procedural complications   
Contusion * 1  38/309 (12.30%) 
Fall * 1  19/309 (6.15%) 
Investigations   
Antinuclear antibody positive * 1  38/309 (12.30%) 
Blood urine present * 1  21/309 (6.80%) 
DNA antibody positive * 1  50/309 (16.18%) 
Gamma-glutamyltransferase increased * 1  17/309 (5.50%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  18/309 (5.83%) 
Osteoporosis * 1  19/309 (6.15%) 
Rheumatoid arthritis * 1  22/309 (7.12%) 
Nervous system disorders   
Dizziness * 1  17/309 (5.50%) 
Headache * 1  33/309 (10.68%) 
Psychiatric disorders   
Insomnia * 1  39/309 (12.62%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  26/309 (8.41%) 
Pharyngolaryngeal pain * 1  20/309 (6.47%) 
Productive cough * 1  18/309 (5.83%) 
Upper respiratory tract inflammation * 1  26/309 (8.41%) 
Skin and subcutaneous tissue disorders   
Dermatitis contact * 1  16/309 (5.18%) 
Eczema * 1  31/309 (10.03%) 
Erythema * 1  26/309 (8.41%) 
Haemorrhage subcutaneous * 1  17/309 (5.50%) 
Hyperkeratosis * 1  16/309 (5.18%) 
Pruritus * 1  37/309 (11.97%) 
Rash * 1  39/309 (12.62%) 
Vascular disorders   
Hypertension * 1  25/309 (8.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00235872     History of Changes
Other Study ID Numbers: M03-651
First Submitted: October 7, 2005
First Posted: October 12, 2005
Results First Submitted: December 9, 2009
Results First Posted: January 13, 2010
Last Update Posted: April 11, 2011