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CompletedNCT00235833Updated Apr 11, 2011Results posted

Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

A Phase 2 interventional study of adalimumab in Rheumatoid Arthritis, sponsored by Abbott. Completed at 7 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-04-11.

Sponsored by Abbott · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 25 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.

Browse Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participation in the prior adalimumab study
  • Body weight less than 100 kg.
  • Subject's who wished to continue the study drug administration
  • Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.

Exclusion criteria

Exclusion Criteria:

  • A subject who experienced any of the following during the prior adalimumab sc dosing study:

    • Advanced or poorly controlled diabetes
    • Any poorly controlled medical condition
    • Intra-articular, intramuscular or iv administration of corticosteroids
    • Joint surgery.
  • A subject who has been prescribed excluded medications during previous adalimumab study.
  • History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
  • A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
  • Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Adalimumab 40 mg eow

    Biological: adalimumab

Interventions

  • Biologicaladalimumab

    40 mg every other week (eow), subcutaneous (sc)

    Also known as: ABT-D2E7, Humira

06

What researchers measure

Primary outcomes

  1. Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)

    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)

Secondary outcomes

  1. Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit

    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)

  2. Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit

    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)

  3. 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

    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)

  4. 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

    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)

  5. 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

    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)

  6. Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit

    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)

  7. Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.

    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)

  8. 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)

    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

  9. Number of Subjects With Morning Stiffness at Each Visit

    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)

07

Results

Posted Jan 29, 2010
Limitations and caveats
Due to the small population, statistical tests were not performed.

Participant flow

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.

Participant flow — Overall Study
MilestoneAdalimumab 40 mg Eow
Started25
Completed9
Not completed16

Outcome measures

PrimaryNumber of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)

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)
Reported as:
Number · participants
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
participantsAdalimumab 40 mg Eow
Week 0 ACR2012
Week 0 ACR507
Week 0 ACR705
Week 6 ACR2015
Week 6 ACR5012
Week 6 ACR705
Week 12 ACR2016
Week 12 ACR5011
Week 12 ACR706
Week 18 ACR2018
Week 18 ACR5011
Week 18 ACR707
Week 24 ACR2016
Week 24 ACR5011
Week 24 ACR704
Week 36 ACR2015
Week 36 ACR5010
Week 36 ACR706
Week 48 ACR2013
Week 48 ACR5010
Week 48 ACR705
Week 60 ACR2012
Week 60 ACR5011
Week 60 ACR706
Week 72 ACR2011
Week 72 ACR5010
Week 72 ACR703
Week 84 ACR2011
Week 84 ACR509
Week 84 ACR707
Week 96 ACR2011
Week 96 ACR5010
Week 96 ACR706
Week 108 ACR2011
Week 108 ACR5010
Week 108 ACR706
Week 120 ACR2010
Week 120 ACR5010
Week 120 ACR706
Week 132 ACR2010
Week 132 ACR507
Week 132 ACR705
Week 144 ACR2010
Week 144 ACR509
Week 144 ACR707
Week 156 ACR209
Week 156 ACR508
Week 156 ACR704
Week 168 ACR209
Week 168 ACR508
Week 168 ACR706
Week 180 ACR2010
Week 180 ACR509
Week 180 ACR705
Week 192 ACR209
Week 192 ACR508
Week 192 ACR705
Week 204 ACR2010
Week 204 ACR508
Week 204 ACR704
Week 216 ACR209
Week 216 ACR508
Week 216 ACR704
Week 228 ACR209
Week 228 ACR507
Week 228 ACR703
Week 240 ACR207
Week 240 ACR504
Week 240 ACR701
Week 252 ACR205
Week 252 ACR503
Week 252 ACR702
Week 264 ACR202
Week 264 ACR501
Week 264 ACR701
Final Value ACR2013
Final Value ACR5011
Final Value ACR708
SecondaryMean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit

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)
Reported as:
Mean · TJC
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
TJCAdalimumab 40 mg Eow
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
SecondaryMean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit

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)
Reported as:
Mean · SJC
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
SJCAdalimumab 40 mg Eow
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
SecondaryMean 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

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)
Reported as:
Mean · mm on scale
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
mm on scaleAdalimumab 40 mg Eow
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
SecondaryMean 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

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)
Reported as:
Mean · mm on scale
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
mm on scaleAdalimumab 40 mg Eow
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
SecondaryMean 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

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)
Reported as:
Mean · mm on scale
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
mm on scaleAdalimumab 40 mg Eow
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
SecondaryMean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit

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)
Reported as:
Mean · units on a scale
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
units on a scaleAdalimumab 40 mg Eow
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 2640.25 ± 1.41
Final Value-0.31 ± 0.77
SecondaryMean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.

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)
Reported as:
Mean · mg/dL
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
mg/dLAdalimumab 40 mg Eow
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 1560.01 ± 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
SecondaryArea 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)

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
Reported as:
Mean · Weeks
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)
WeeksAdalimumab 40 mg Eow
Week 0 - Week 63.2 ± 2.7
Week 0 - Week 127.0 ± 5.5
Week 0 - Week 1811.0 ± 8.0
Week 0 - Week 2415.1 ± 10.6
Week 0 - Week 3622.6 ± 15.9
Week 0 - Week 4829.3 ± 21.1
Week 0 - Week 6035.3 ± 26.3
Week 0 - Week 7240.8 ± 31.3
Week 0 - Week 8446.1 ± 36.2
Week 0 - Week 9651.4 ± 41.3
Week 0 - Week 10856.6 ± 46.7
Week 0 - Week 12061.7 ± 52.0
Week 0 - Week 13266.5 ± 57.2
Week 0 - Week 14471.3 ± 62.5
Week 0 - Week 15675.8 ± 67.7
Week 0 - Week 16880.2 ± 72.7
Week 0 - Week 18084.7 ± 78.0
Week 0 - Week 19289.3 ± 83.4
Week 0 - Week 20493.8 ± 88.2
Week 0 - Week 21698.4 ± 92.7
Week 0 - Week 228102.7 ± 97.1
Week 0 - Week 240106.6 ± 101.0
Week 0 - Week 252109.4 ± 104.2
Week 0 - Week 264111.1 ± 106.4
SecondaryNumber of Subjects With Morning Stiffness at Each Visit

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)
Reported as:
Number · participants
Number of Subjects With Morning Stiffness at Each Visit
participantsAdalimumab 40 mg Eow
Week 016
Week 615
Week 1211
Week 1811
Week 249
Week 3610
Week 486
Week 605
Week 727
Week 846
Week 964
Week 1084
Week 1203
Week 1323
Week 1443
Week 1563
Week 1682
Week 1802
Week 1923
Week 2044
Week 2163
Week 2283
Week 2403
Week 2522
Week 2641
Final Value15

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Adalimumab 40 mg Eow—10/25 (40%)25/25 (100%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventAdalimumab 40 mg Eow
Rheumatoid arthritisMusculoskeletal and connective tissue disorders3/25
LymphadenitisBlood and lymphatic system disorders1/25
Brugada syndromeCardiac disorders1/25
PyrexiaGeneral disorders1/25
PyelonephritisInfections and infestations1/25
SepsisInfections and infestations1/25
Tendon ruptureInjury, poisoning and procedural complications1/25
C-reactive protein increasedInvestigations1/25
ArthralgiaMusculoskeletal and connective tissue disorders1/25
Metastases to lymph nodesNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/25
Most frequent other events
Showing 10 of 53
Most frequent other events
EventAdalimumab 40 mg Eow
NasopharyngitisInfections and infestations15/25
DiarrhoeaGastrointestinal disorders6/25
PruritusSkin and subcutaneous tissue disorders5/25
Adverse drug reactionGeneral disorders4/25
Hepatic function abnormalHepatobiliary disorders4/25
CystitisInfections and infestations4/25
ContusionInjury, poisoning and procedural complications4/25
Back painMusculoskeletal and connective tissue disorders4/25
InsomniaPsychiatric disorders4/25
RhinorrhoeaRespiratory, thoracic and mediastinal disorders4/25

Baseline characteristics

Age Continuous
Age Continuous(years)Adalimumab 40 mg Eow
Mean54.1 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Adalimumab 40 mg Eow
Female21
Male4
Region of Enrollment
Region of Enrollment(participants)Adalimumab 40 mg Eow
Japan25
08

Study locations

7 sites
  • Tokyo, Metropolis, Japan
  • Fukuoka, Prefecture, Japan
  • Hiroshima, Prefecture, Japan
  • Ibaraki, Prefecture, Japan
  • Nagasaki, Prefecture, Japan
  • Osaka, Prefecture, Japan
  • Saitama, Prefecture, Japan
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2003 and a primary completion of Oct 2004. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2010, 5 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2005
First posted
Oct 12, 2005
Start
Jun 2003
Primary completionActual
Oct 2004
Results first posted
Jan 29, 2010
Last update
Apr 11, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00235833
Lead sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd, Eisai Co., Ltd.
First posted
Oct 12, 2005
Start date
Jun 2003
Primary completion
Oct 2004
Results posted
Jan 29, 2010
Last update
Apr 11, 2011

Study contacts

Shigeki Hashimoto, Ph.D.
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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