Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT01076959
Collaborator
(none)
7,972
1723
36
4.6
0.1

Study Details

Study Description

Brief Summary

To clarify the following matters:
  • Unknown adverse reactions (especially clinically significant adverse reactions)

  • Incidence and conditions of occurrence of adverse reactions in the clinical setting

  • Factors that may affect the safety and effectiveness of Humira

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    7972 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Humira 40 mg/0.8 mL for Subcutaneous Injection - Drug Use Investigation (All Patient Investigation) for Rheumatoid Arthritis
    Study Start Date :
    Jun 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Humira

    The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the PMDA. The safety analysis set included all patients who met all eligibility criteria and received at least one dose of Humira. The full analysis set included all patients who were treated with Humira for at least 2 weeks and had complete DAS 28 assessments at baseline and at least one other time point.

    Outcome Measures

    Primary Outcome Measures

    1. Total Number of Patients With Adverse Events [Baseline to Week 24]

      Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.

    2. Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 [Week 4]

      Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

    3. Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 [Week 12]

      Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

    4. Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 [Week 24]

      Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

    Secondary Outcome Measures

    1. Physicians' Overall Effectiveness Response Rating [Week 24]

      Physicians' rated the level of overall patient improvement as "markedly improved," "improved," "not changed," or "not assessable" by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients prescribed and treated with Humira are included in this survey.
    Exclusion Criteria:
    • Contraindications according to the Package Insert:

    • Patients who have serious infections,

    • Patients who have tuberculosis,

    • Patients with a history of hypersensitivity to any ingredient of Humira,

    • Patients who have demyelinating disease or with a history of demyelinating disease,

    • Patients who have cardiac failure congestive.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 35904 Aichi Japan
    2 Site Reference ID/Investigator# 35905 Aichi Japan
    3 Site Reference ID/Investigator# 35906 Aichi Japan
    4 Site Reference ID/Investigator# 35907 Aichi Japan
    5 Site Reference ID/Investigator# 35908 Aichi Japan
    6 Site Reference ID/Investigator# 35909 Aichi Japan
    7 Site Reference ID/Investigator# 35912 Aichi Japan
    8 Site Reference ID/Investigator# 35913 Aichi Japan
    9 Site Reference ID/Investigator# 35914 Aichi Japan
    10 Site Reference ID/Investigator# 35915 Aichi Japan
    11 Site Reference ID/Investigator# 35916 Aichi Japan
    12 Site Reference ID/Investigator# 35917 Aichi Japan
    13 Site Reference ID/Investigator# 35918 Aichi Japan
    14 Site Reference ID/Investigator# 35919 Aichi Japan
    15 Site Reference ID/Investigator# 35920 Aichi Japan
    16 Site Reference ID/Investigator# 35921 Aichi Japan
    17 Site Reference ID/Investigator# 35922 Aichi Japan
    18 Site Reference ID/Investigator# 35923 Aichi Japan
    19 Site Reference ID/Investigator# 35924 Aichi Japan
    20 Site Reference ID/Investigator# 36611 Aichi Japan
    21 Site Reference ID/Investigator# 36644 Aichi Japan
    22 Site Reference ID/Investigator# 36650 Aichi Japan
    23 Site Reference ID/Investigator# 36652 Aichi Japan
    24 Site Reference ID/Investigator# 36676 Aichi Japan
    25 Site Reference ID/Investigator# 36681 Aichi Japan
    26 Site Reference ID/Investigator# 36689 Aichi Japan
    27 Site Reference ID/Investigator# 36696 Aichi Japan
    28 Site Reference ID/Investigator# 36733 Aichi Japan
    29 Site Reference ID/Investigator# 36752 Aichi Japan
    30 Site Reference ID/Investigator# 36819 Aichi Japan
    31 Site Reference ID/Investigator# 36843 Aichi Japan
    32 Site Reference ID/Investigator# 36867 Aichi Japan
    33 Site Reference ID/Investigator# 36923 Aichi Japan
    34 Site Reference ID/Investigator# 36943 Aichi Japan
    35 Site Reference ID/Investigator# 36944 Aichi Japan
    36 Site Reference ID/Investigator# 36945 Aichi Japan
    37 Site Reference ID/Investigator# 39128 Aichi Japan
    38 Site Reference ID/Investigator# 39129 Aichi Japan
    39 Site Reference ID/Investigator# 39130 Aichi Japan
    40 Site Reference ID/Investigator# 39131 Aichi Japan
    41 Site Reference ID/Investigator# 39132 Aichi Japan
    42 Site Reference ID/Investigator# 39133 Aichi Japan
    43 Site Reference ID/Investigator# 39134 Aichi Japan
    44 Site Reference ID/Investigator# 39135 Aichi Japan
    45 Site Reference ID/Investigator# 39136 Aichi Japan
    46 Site Reference ID/Investigator# 39137 Aichi Japan
    47 Site Reference ID/Investigator# 39138 Aichi Japan
    48 Site Reference ID/Investigator# 39140 Aichi Japan
    49 Site Reference ID/Investigator# 39141 Aichi Japan
    50 Site Reference ID/Investigator# 39142 Aichi Japan
    51 Site Reference ID/Investigator# 39143 Aichi Japan
    52 Site Reference ID/Investigator# 39144 Aichi Japan
    53 Site Reference ID/Investigator# 39145 Aichi Japan
    54 Site Reference ID/Investigator# 39146 Aichi Japan
    55 Site Reference ID/Investigator# 39147 Aichi Japan
    56 Site Reference ID/Investigator# 39148 Aichi Japan
    57 Site Reference ID/Investigator# 39149 Aichi Japan
    58 Site Reference ID/Investigator# 39150 Aichi Japan
    59 Site Reference ID/Investigator# 39151 Aichi Japan
    60 Site Reference ID/Investigator# 39152 Aichi Japan
    61 Site Reference ID/Investigator# 39153 Aichi Japan
    62 Site Reference ID/Investigator# 39154 Aichi Japan
    63 Site Reference ID/Investigator# 39155 Aichi Japan
    64 Site Reference ID/Investigator# 39156 Aichi Japan
    65 Site Reference ID/Investigator# 39157 Aichi Japan
    66 Site Reference ID/Investigator# 39158 Aichi Japan
    67 Site Reference ID/Investigator# 39159 Aichi Japan
    68 Site Reference ID/Investigator# 39160 Aichi Japan
    69 Site Reference ID/Investigator# 39161 Aichi Japan
    70 Site Reference ID/Investigator# 39162 Aichi Japan
    71 Site Reference ID/Investigator# 39163 Aichi Japan
    72 Site Reference ID/Investigator# 39165 Aichi Japan
    73 Site Reference ID/Investigator# 39166 Aichi Japan
    74 Site Reference ID/Investigator# 39167 Aichi Japan
    75 Site Reference ID/Investigator# 39168 Aichi Japan
    76 Site Reference ID/Investigator# 42712 Aichi Japan
    77 Site Reference ID/Investigator# 42715 Aichi Japan
    78 Site Reference ID/Investigator# 42723 Aichi Japan
    79 Site Reference ID/Investigator# 42738 Aichi Japan
    80 Site Reference ID/Investigator# 42756 Aichi Japan
    81 Site Reference ID/Investigator# 42757 Aichi Japan
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    85 Site Reference ID/Investigator# 42844 Aichi Japan
    86 Site Reference ID/Investigator# 42845 Aichi Japan
    87 Site Reference ID/Investigator# 42846 Aichi Japan
    88 Site Reference ID/Investigator# 42851 Aichi Japan
    89 Site Reference ID/Investigator# 42852 Aichi Japan
    90 Site Reference ID/Investigator# 58587 Aichi Japan
    91 Site Reference ID/Investigator# 58612 Aichi Japan
    92 Site Reference ID/Investigator# 58680 Aichi Japan
    93 Site Reference ID/Investigator# 58681 Aichi Japan
    94 Site Reference ID/Investigator# 58682 Aichi Japan
    95 Site Reference ID/Investigator# 58687 Aichi Japan
    96 Site Reference ID/Investigator# 58838 Aichi Japan
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    99 Site Reference ID/Investigator# 58844 Aichi Japan
    100 Site Reference ID/Investigator# 58845 Aichi Japan
    101 Site Reference ID/Investigator# 58872 Aichi Japan
    102 Site Reference ID/Investigator# 39508 Aki Takada Japan
    103 Site Reference ID/Investigator# 36549 Akita Japan
    104 Site Reference ID/Investigator# 36796 Akita Japan
    105 Site Reference ID/Investigator# 36948 Akita Japan
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    111 Site Reference ID/Investigator# 42717 Akita Japan
    112 Site Reference ID/Investigator# 42871 Akita Japan
    113 Site Reference ID/Investigator# 42872 Akita Japan
    114 Site Reference ID/Investigator# 58820 Akita Japan
    115 Site Reference ID/Investigator# 39865 Amagasaki Japan
    116 Site Reference ID/Investigator# 39866 Amagasaki Japan
    117 Site Reference ID/Investigator# 35925 Aomori Japan
    118 Site Reference ID/Investigator# 35926 Aomori Japan
    119 Site Reference ID/Investigator# 35927 Aomori Japan
    120 Site Reference ID/Investigator# 39176 Aomori Japan
    121 Site Reference ID/Investigator# 39177 Aomori Japan
    122 Site Reference ID/Investigator# 39181 Aomori Japan
    123 Site Reference ID/Investigator# 39182 Aomori Japan
    124 Site Reference ID/Investigator# 39192 Aomori Japan
    125 Site Reference ID/Investigator# 42866 Aomori Japan
    126 Site Reference ID/Investigator# 42867 Aomori Japan
    127 Site Reference ID/Investigator# 42868 Aomori Japan
    128 Site Reference ID/Investigator# 58647 Aomori Japan
    129 Site Reference ID/Investigator# 58819 Aomori Japan
    130 Site Reference ID/Investigator# 36605 Ashiya Japan
    131 Site Reference ID/Investigator# 36082 Chiba Japan
    132 Site Reference ID/Investigator# 36083 Chiba Japan
    133 Site Reference ID/Investigator# 36084 Chiba Japan
    134 Site Reference ID/Investigator# 36085 Chiba Japan
    135 Site Reference ID/Investigator# 36086 Chiba Japan
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    141 Site Reference ID/Investigator# 36449 Chiba Japan
    142 Site Reference ID/Investigator# 36455 Chiba Japan
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    144 Site Reference ID/Investigator# 36610 Chiba Japan
    145 Site Reference ID/Investigator# 36693 Chiba Japan
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    150 Site Reference ID/Investigator# 38528 Chiba Japan
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    159 Site Reference ID/Investigator# 39209 Chiba Japan
    160 Site Reference ID/Investigator# 39210 Chiba Japan
    161 Site Reference ID/Investigator# 39211 Chiba Japan
    162 Site Reference ID/Investigator# 39212 Chiba Japan
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    164 Site Reference ID/Investigator# 39214 Chiba Japan
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    166 Site Reference ID/Investigator# 39216 Chiba Japan
    167 Site Reference ID/Investigator# 39217 Chiba Japan
    168 Site Reference ID/Investigator# 39221 Chiba Japan
    169 Site Reference ID/Investigator# 39224 Chiba Japan
    170 Site Reference ID/Investigator# 39225 Chiba Japan
    171 Site Reference ID/Investigator# 39226 Chiba Japan
    172 Site Reference ID/Investigator# 39227 Chiba Japan
    173 Site Reference ID/Investigator# 39228 Chiba Japan
    174 Site Reference ID/Investigator# 42761 Chiba Japan
    175 Site Reference ID/Investigator# 42828 Chiba Japan
    176 Site Reference ID/Investigator# 42830 Chiba Japan
    177 Site Reference ID/Investigator# 42831 Chiba Japan
    178 Site Reference ID/Investigator# 42832 Chiba Japan
    179 Site Reference ID/Investigator# 42833 Chiba Japan
    180 Site Reference ID/Investigator# 58668 Chiba Japan
    181 Site Reference ID/Investigator# 58676 Chiba Japan
    182 Site Reference ID/Investigator# 58831 Chiba Japan
    183 Site Reference ID/Investigator# 39964 Chuo Japan
    184 Site Reference ID/Investigator# 39965 Chuo Japan
    185 Site Reference ID/Investigator# 42725 Daisuke Japan
    186 Site Reference ID/Investigator# 36092 Ehime Japan
    187 Site Reference ID/Investigator# 36093 Ehime Japan
    188 Site Reference ID/Investigator# 36903 Ehime Japan
    189 Site Reference ID/Investigator# 39229 Ehime Japan
    190 Site Reference ID/Investigator# 39230 Ehime Japan
    191 Site Reference ID/Investigator# 39231 Ehime Japan
    192 Site Reference ID/Investigator# 39234 Ehime Japan
    193 Site Reference ID/Investigator# 39235 Ehime Japan
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    195 Site Reference ID/Investigator# 39240 Ehime Japan
    196 Site Reference ID/Investigator# 39241 Ehime Japan
    197 Site Reference ID/Investigator# 42740 Ehime Japan
    198 Site Reference ID/Investigator# 42815 Ehime Japan
    199 Site Reference ID/Investigator# 58592 Ehime Japan
    200 Site Reference ID/Investigator# 58601 Ehime Japan
    201 Site Reference ID/Investigator# 58778 Ehime Japan
    202 Site Reference ID/Investigator# 58779 Ehime Japan
    203 Site Reference ID/Investigator# 39910 Fuchu Japan
    204 Site Reference ID/Investigator# 42825 Fujisawa Japan
    205 Site Reference ID/Investigator# 36094 Fukui Japan
    206 Site Reference ID/Investigator# 36095 Fukui Japan
    207 Site Reference ID/Investigator# 36096 Fukui Japan
    208 Site Reference ID/Investigator# 36097 Fukui Japan
    209 Site Reference ID/Investigator# 36548 Fukui Japan
    210 Site Reference ID/Investigator# 36571 Fukui Japan
    211 Site Reference ID/Investigator# 36742 Fukui Japan
    212 Site Reference ID/Investigator# 36911 Fukui Japan
    213 Site Reference ID/Investigator# 39246 Fukui Japan
    214 Site Reference ID/Investigator# 39247 Fukui Japan
    215 Site Reference ID/Investigator# 39248 Fukui Japan
    216 Site Reference ID/Investigator# 39252 Fukui Japan
    217 Site Reference ID/Investigator# 39253 Fukui Japan
    218 Site Reference ID/Investigator# 39254 Fukui Japan
    219 Site Reference ID/Investigator# 39255 Fukui Japan
    220 Site Reference ID/Investigator# 39256 Fukui Japan
    221 Site Reference ID/Investigator# 42762 Fukui Japan
    222 Site Reference ID/Investigator# 42924 Fukui Japan
    223 Site Reference ID/Investigator# 58595 Fukui Japan
    224 Site Reference ID/Investigator# 58611 Fukui Japan
    225 Site Reference ID/Investigator# 58706 Fukui Japan
    226 Site Reference ID/Investigator# 36099 Fukuoka Japan
    227 Site Reference ID/Investigator# 36100 Fukuoka Japan
    228 Site Reference ID/Investigator# 36101 Fukuoka Japan
    229 Site Reference ID/Investigator# 36102 Fukuoka Japan
    230 Site Reference ID/Investigator# 36103 Fukuoka Japan
    231 Site Reference ID/Investigator# 36104 Fukuoka Japan
    232 Site Reference ID/Investigator# 36105 Fukuoka Japan
    233 Site Reference ID/Investigator# 36106 Fukuoka Japan
    234 Site Reference ID/Investigator# 36107 Fukuoka Japan
    235 Site Reference ID/Investigator# 36108 Fukuoka Japan
    236 Site Reference ID/Investigator# 36109 Fukuoka Japan
    237 Site Reference ID/Investigator# 36110 Fukuoka Japan
    238 Site Reference ID/Investigator# 36111 Fukuoka Japan
    239 Site Reference ID/Investigator# 36112 Fukuoka Japan
    240 Site Reference ID/Investigator# 36113 Fukuoka Japan
    241 Site Reference ID/Investigator# 36114 Fukuoka Japan
    242 Site Reference ID/Investigator# 36115 Fukuoka Japan
    243 Site Reference ID/Investigator# 36116 Fukuoka Japan
    244 Site Reference ID/Investigator# 36118 Fukuoka Japan
    245 Site Reference ID/Investigator# 36120 Fukuoka Japan
    246 Site Reference ID/Investigator# 36121 Fukuoka Japan
    247 Site Reference ID/Investigator# 36122 Fukuoka Japan
    248 Site Reference ID/Investigator# 36445 Fukuoka Japan
    249 Site Reference ID/Investigator# 36544 Fukuoka Japan
    250 Site Reference ID/Investigator# 36568 Fukuoka Japan
    251 Site Reference ID/Investigator# 36597 Fukuoka Japan
    252 Site Reference ID/Investigator# 36601 Fukuoka Japan
    253 Site Reference ID/Investigator# 36606 Fukuoka Japan
    254 Site Reference ID/Investigator# 36642 Fukuoka Japan
    255 Site Reference ID/Investigator# 36645 Fukuoka Japan
    256 Site Reference ID/Investigator# 36651 Fukuoka Japan
    257 Site Reference ID/Investigator# 36660 Fukuoka Japan
    258 Site Reference ID/Investigator# 36670 Fukuoka Japan
    259 Site Reference ID/Investigator# 36692 Fukuoka Japan
    260 Site Reference ID/Investigator# 36699 Fukuoka Japan
    261 Site Reference ID/Investigator# 36748 Fukuoka Japan
    262 Site Reference ID/Investigator# 36799 Fukuoka Japan
    263 Site Reference ID/Investigator# 36801 Fukuoka Japan
    264 Site Reference ID/Investigator# 36870 Fukuoka Japan
    265 Site Reference ID/Investigator# 36907 Fukuoka Japan
    266 Site Reference ID/Investigator# 36910 Fukuoka Japan
    267 Site Reference ID/Investigator# 36914 Fukuoka Japan
    268 Site Reference ID/Investigator# 39174 Fukuoka Japan
    269 Site Reference ID/Investigator# 39175 Fukuoka Japan
    270 Site Reference ID/Investigator# 39178 Fukuoka Japan
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    273 Site Reference ID/Investigator# 39184 Fukuoka Japan
    274 Site Reference ID/Investigator# 39185 Fukuoka Japan
    275 Site Reference ID/Investigator# 39186 Fukuoka Japan
    276 Site Reference ID/Investigator# 39187 Fukuoka Japan
    277 Site Reference ID/Investigator# 39188 Fukuoka Japan
    278 Site Reference ID/Investigator# 39189 Fukuoka Japan
    279 Site Reference ID/Investigator# 39190 Fukuoka Japan
    280 Site Reference ID/Investigator# 39191 Fukuoka Japan
    281 Site Reference ID/Investigator# 39201 Fukuoka Japan
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    285 Site Reference ID/Investigator# 39205 Fukuoka Japan
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    288 Site Reference ID/Investigator# 39208 Fukuoka Japan
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    290 Site Reference ID/Investigator# 39219 Fukuoka Japan
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    298 Site Reference ID/Investigator# 42805 Fukuoka Japan
    299 Site Reference ID/Investigator# 58580 Fukuoka Japan
    300 Site Reference ID/Investigator# 58782 Fukuoka Japan
    301 Site Reference ID/Investigator# 58786 Fukuoka Japan
    302 Site Reference ID/Investigator# 58867 Fukuoka Japan
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    304 Site Reference ID/Investigator# 36002 Fukushima Japan
    305 Site Reference ID/Investigator# 36447 Fukushima Japan
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    307 Site Reference ID/Investigator# 36649 Fukushima Japan
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    310 Site Reference ID/Investigator# 36821 Fukushima Japan
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    312 Site Reference ID/Investigator# 38525 Fukushima Japan
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    320 Site Reference ID/Investigator# 39249 Fukushima Japan
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    322 Site Reference ID/Investigator# 42720 Fukushima Japan
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    324 Site Reference ID/Investigator# 42944 Fukushima Japan
    325 Site Reference ID/Investigator# 42945 Fukushima Japan
    326 Site Reference ID/Investigator# 42946 Fukushima Japan
    327 Site Reference ID/Investigator# 58651 Fukushima Japan
    328 Site Reference ID/Investigator# 58823 Fukushima Japan
    329 Site Reference ID/Investigator# 36003 Gifu Japan
    330 Site Reference ID/Investigator# 36004 Gifu Japan
    331 Site Reference ID/Investigator# 36005 Gifu Japan
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    340 Site Reference ID/Investigator# 36814 Gifu Japan
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    345 Site Reference ID/Investigator# 36942 Gifu Japan
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    360 Site Reference ID/Investigator# 42855 Gifu Japan
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    367 Site Reference ID/Investigator# 58689 Gifu Japan
    368 Site Reference ID/Investigator# 58690 Gifu Japan
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    370 Site Reference ID/Investigator# 58785 Gifu Japan
    371 Site Reference ID/Investigator# 58846 Gifu Japan
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    373 Site Reference ID/Investigator# 58848 Gifu Japan
    374 Site Reference ID/Investigator# 58849 Gifu Japan
    375 Site Reference ID/Investigator# 58850 Gifu Japan
    376 Site Reference ID/Investigator# 36008 Gunma Japan
    377 Site Reference ID/Investigator# 36009 Gunma Japan
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    380 Site Reference ID/Investigator# 36012 Gunma Japan
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    382 Site Reference ID/Investigator# 36936 Gunma Japan
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    384 Site Reference ID/Investigator# 39484 Gunma Japan
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    386 Site Reference ID/Investigator# 39491 Gunma Japan
    387 Site Reference ID/Investigator# 39493 Gunma Japan
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    390 Site Reference ID/Investigator# 39496 Gunma Japan
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    397 Site Reference ID/Investigator# 42900 Gunma Japan
    398 Site Reference ID/Investigator# 42903 Gunma Japan
    399 Site Reference ID/Investigator# 58657 Gunma Japan
    400 Site Reference ID/Investigator# 39446 Gyoda Japan
    401 Site Reference ID/Investigator# 39948 Hagi Japan
    402 Site Reference ID/Investigator# 39540 Himeji Japan
    403 Site Reference ID/Investigator# 36014 Hiroshima Japan
    404 Site Reference ID/Investigator# 36015 Hiroshima Japan
    405 Site Reference ID/Investigator# 36016 Hiroshima Japan
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    411 Site Reference ID/Investigator# 36744 Hiroshima Japan
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    414 Site Reference ID/Investigator# 36840 Hiroshima Japan
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    416 Site Reference ID/Investigator# 38527 Hiroshima Japan
    417 Site Reference ID/Investigator# 39500 Hiroshima Japan
    418 Site Reference ID/Investigator# 39501 Hiroshima Japan
    419 Site Reference ID/Investigator# 39502 Hiroshima Japan
    420 Site Reference ID/Investigator# 39503 Hiroshima Japan
    421 Site Reference ID/Investigator# 39504 Hiroshima Japan
    422 Site Reference ID/Investigator# 39505 Hiroshima Japan
    423 Site Reference ID/Investigator# 39506 Hiroshima Japan
    424 Site Reference ID/Investigator# 39507 Hiroshima Japan
    425 Site Reference ID/Investigator# 39510 Hiroshima Japan
    426 Site Reference ID/Investigator# 39516 Hiroshima Japan
    427 Site Reference ID/Investigator# 42733 Hiroshima Japan
    428 Site Reference ID/Investigator# 42734 Hiroshima Japan
    429 Site Reference ID/Investigator# 42841 Hiroshima Japan
    430 Site Reference ID/Investigator# 58607 Hiroshima Japan
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    890 Site Reference ID/Investigator# 58692 Mie Japan
    891 Site Reference ID/Investigator# 58793 Mie Japan
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    899 Site Reference ID/Investigator# 36802 Miyagi Japan
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    902 Site Reference ID/Investigator# 39307 Miyagi Japan
    903 Site Reference ID/Investigator# 39311 Miyagi Japan
    904 Site Reference ID/Investigator# 39312 Miyagi Japan
    905 Site Reference ID/Investigator# 39314 Miyagi Japan
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    908 Site Reference ID/Investigator# 39917 Miyagi Japan
    909 Site Reference ID/Investigator# 42775 Miyagi Japan
    910 Site Reference ID/Investigator# 42780 Miyagi Japan
    911 Site Reference ID/Investigator# 42943 Miyagi Japan
    912 Site Reference ID/Investigator# 58552 Miyagi Japan
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    1382 Site Reference ID/Investigator# 58693 Shizuoka Japan
    1383 Site Reference ID/Investigator# 58840 Shizuoka Japan
    1384 Site Reference ID/Investigator# 58841 Shizuoka Japan
    1385 Site Reference ID/Investigator# 58842 Shizuoka Japan
    1386 Site Ref # / Investigator 72773 Suwa Japan
    1387 Site Reference ID/Investigator# 36730 Takamatsu Japan
    1388 Site Reference ID/Investigator# 39403 Takatsuki Japan
    1389 Site Reference ID/Investigator# 39405 Takatsuki Japan
    1390 Site Reference ID/Investigator# 39406 Takatsuki Japan
    1391 Site Reference ID/Investigator# 36124 Tochigi Japan
    1392 Site Reference ID/Investigator# 36127 Tochigi Japan
    1393 Site Reference ID/Investigator# 36128 Tochigi Japan
    1394 Site Reference ID/Investigator# 36691 Tochigi Japan
    1395 Site Reference ID/Investigator# 36874 Tochigi Japan
    1396 Site Reference ID/Investigator# 36876 Tochigi Japan
    1397 Site Reference ID/Investigator# 36880 Tochigi Japan
    1398 Site Reference ID/Investigator# 36881 Tochigi Japan
    1399 Site Reference ID/Investigator# 36882 Tochigi Japan
    1400 Site Reference ID/Investigator# 36884 Tochigi Japan
    1401 Site Reference ID/Investigator# 36887 Tochigi Japan
    1402 Site Reference ID/Investigator# 36888 Tochigi Japan
    1403 Site Reference ID/Investigator# 36930 Tochigi Japan
    1404 Site Reference ID/Investigator# 36959 Tochigi Japan
    1405 Site Reference ID/Investigator# 36960 Tochigi Japan
    1406 Site Reference ID/Investigator# 36961 Tochigi Japan
    1407 Site Reference ID/Investigator# 38524 Tochigi Japan
    1408 Site Reference ID/Investigator# 39787 Tochigi Japan
    1409 Site Reference ID/Investigator# 39788 Tochigi Japan
    1410 Site Reference ID/Investigator# 39794 Tochigi Japan
    1411 Site Reference ID/Investigator# 39795 Tochigi Japan
    1412 Site Reference ID/Investigator# 39796 Tochigi Japan
    1413 Site Reference ID/Investigator# 39797 Tochigi Japan
    1414 Site Reference ID/Investigator# 39798 Tochigi Japan
    1415 Site Reference ID/Investigator# 39801 Tochigi Japan
    1416 Site Reference ID/Investigator# 39802 Tochigi Japan
    1417 Site Reference ID/Investigator# 42727 Tochigi Japan
    1418 Site Reference ID/Investigator# 42728 Tochigi Japan
    1419 Site Reference ID/Investigator# 42899 Tochigi Japan
    1420 Site Reference ID/Investigator# 58544 Tochigi Japan
    1421 Site Reference ID/Investigator# 58567 Tochigi Japan
    1422 Site Reference ID/Investigator# 58609 Tochigi Japan
    1423 Site Reference ID/Investigator# 58655 Tochigi Japan
    1424 Site Reference ID/Investigator# 58656 Tochigi Japan
    1425 Site Reference ID/Investigator# 58826 Tochigi Japan
    1426 Site Reference ID/Investigator# 36125 Tokushima Japan
    1427 Site Reference ID/Investigator# 36129 Tokushima Japan
    1428 Site Reference ID/Investigator# 36577 Tokushima Japan
    1429 Site Reference ID/Investigator# 36685 Tokushima Japan
    1430 Site Reference ID/Investigator# 36883 Tokushima Japan
    1431 Site Reference ID/Investigator# 39803 Tokushima Japan
    1432 Site Reference ID/Investigator# 39806 Tokushima Japan
    1433 Site Reference ID/Investigator# 39809 Tokushima Japan
    1434 Site Reference ID/Investigator# 39810 Tokushima Japan
    1435 Site Reference ID/Investigator# 42747 Tokushima Japan
    1436 Site Reference ID/Investigator# 42816 Tokushima Japan
    1437 Site Reference ID/Investigator# 58865 Tokushima Japan
    1438 Site Reference ID/Investigator# 14581 Tokyo Japan
    1439 Site Reference ID/Investigator# 36131 Tokyo Japan
    1440 Site Reference ID/Investigator# 36132 Tokyo Japan
    1441 Site Reference ID/Investigator# 36133 Tokyo Japan
    1442 Site Reference ID/Investigator# 36134 Tokyo Japan
    1443 Site Reference ID/Investigator# 36135 Tokyo Japan
    1444 Site Reference ID/Investigator# 36136 Tokyo Japan
    1445 Site Reference ID/Investigator# 36138 Tokyo Japan
    1446 Site Reference ID/Investigator# 36139 Tokyo Japan
    1447 Site Reference ID/Investigator# 36140 Tokyo Japan
    1448 Site Reference ID/Investigator# 36141 Tokyo Japan
    1449 Site Reference ID/Investigator# 36142 Tokyo Japan
    1450 Site Reference ID/Investigator# 36143 Tokyo Japan
    1451 Site Reference ID/Investigator# 36144 Tokyo Japan
    1452 Site Reference ID/Investigator# 36145 Tokyo Japan
    1453 Site Reference ID/Investigator# 36146 Tokyo Japan
    1454 Site Reference ID/Investigator# 36147 Tokyo Japan
    1455 Site Reference ID/Investigator# 36149 Tokyo Japan
    1456 Site Reference ID/Investigator# 36150 Tokyo Japan
    1457 Site Reference ID/Investigator# 36151 Tokyo Japan
    1458 Site Reference ID/Investigator# 36153 Tokyo Japan
    1459 Site Reference ID/Investigator# 36154 Tokyo Japan
    1460 Site Reference ID/Investigator# 36155 Tokyo Japan
    1461 Site Reference ID/Investigator# 36156 Tokyo Japan
    1462 Site Reference ID/Investigator# 36157 Tokyo Japan
    1463 Site Reference ID/Investigator# 36158 Tokyo Japan
    1464 Site Reference ID/Investigator# 36159 Tokyo Japan
    1465 Site Reference ID/Investigator# 36160 Tokyo Japan
    1466 Site Reference ID/Investigator# 36161 Tokyo Japan
    1467 Site Reference ID/Investigator# 36162 Tokyo Japan
    1468 Site Reference ID/Investigator# 36163 Tokyo Japan
    1469 Site Reference ID/Investigator# 36164 Tokyo Japan
    1470 Site Reference ID/Investigator# 36165 Tokyo Japan
    1471 Site Reference ID/Investigator# 36166 Tokyo Japan
    1472 Site Reference ID/Investigator# 36167 Tokyo Japan
    1473 Site Reference ID/Investigator# 36168 Tokyo Japan
    1474 Site Reference ID/Investigator# 36169 Tokyo Japan
    1475 Site Reference ID/Investigator# 36453 Tokyo Japan
    1476 Site Reference ID/Investigator# 36561 Tokyo Japan
    1477 Site Reference ID/Investigator# 36562 Tokyo Japan
    1478 Site Reference ID/Investigator# 36563 Tokyo Japan
    1479 Site Reference ID/Investigator# 36565 Tokyo Japan
    1480 Site Reference ID/Investigator# 36575 Tokyo Japan
    1481 Site Reference ID/Investigator# 36581 Tokyo Japan
    1482 Site Reference ID/Investigator# 36590 Tokyo Japan
    1483 Site Reference ID/Investigator# 36593 Tokyo Japan
    1484 Site Reference ID/Investigator# 36594 Tokyo Japan
    1485 Site Reference ID/Investigator# 36596 Tokyo Japan
    1486 Site Reference ID/Investigator# 36615 Tokyo Japan
    1487 Site Reference ID/Investigator# 36641 Tokyo Japan
    1488 Site Reference ID/Investigator# 36653 Tokyo Japan
    1489 Site Reference ID/Investigator# 36664 Tokyo Japan
    1490 Site Reference ID/Investigator# 36682 Tokyo Japan
    1491 Site Reference ID/Investigator# 36684 Tokyo Japan
    1492 Site Reference ID/Investigator# 36690 Tokyo Japan
    1493 Site Reference ID/Investigator# 36698 Tokyo Japan
    1494 Site Reference ID/Investigator# 36725 Tokyo Japan
    1495 Site Reference ID/Investigator# 36726 Tokyo Japan
    1496 Site Reference ID/Investigator# 36751 Tokyo Japan
    1497 Site Reference ID/Investigator# 36792 Tokyo Japan
    1498 Site Reference ID/Investigator# 36794 Tokyo Japan
    1499 Site Reference ID/Investigator# 36803 Tokyo Japan
    1500 Site Reference ID/Investigator# 36810 Tokyo Japan
    1501 Site Reference ID/Investigator# 36812 Tokyo Japan
    1502 Site Reference ID/Investigator# 36816 Tokyo Japan
    1503 Site Reference ID/Investigator# 36818 Tokyo Japan
    1504 Site Reference ID/Investigator# 36845 Tokyo Japan
    1505 Site Reference ID/Investigator# 36885 Tokyo Japan
    1506 Site Reference ID/Investigator# 36886 Tokyo Japan
    1507 Site Reference ID/Investigator# 36915 Tokyo Japan
    1508 Site Reference ID/Investigator# 36919 Tokyo Japan
    1509 Site Reference ID/Investigator# 36934 Tokyo Japan
    1510 Site Reference ID/Investigator# 36956 Tokyo Japan
    1511 Site Reference ID/Investigator# 36963 Tokyo Japan
    1512 Site Reference ID/Investigator# 39582 Tokyo Japan
    1513 Site Reference ID/Investigator# 39583 Tokyo Japan
    1514 Site Reference ID/Investigator# 39584 Tokyo Japan
    1515 Site Reference ID/Investigator# 39585 Tokyo Japan
    1516 Site Reference ID/Investigator# 39622 Tokyo Japan
    1517 Site Reference ID/Investigator# 39623 Tokyo Japan
    1518 Site Reference ID/Investigator# 39697 Tokyo Japan
    1519 Site Reference ID/Investigator# 39804 Tokyo Japan
    1520 Site Reference ID/Investigator# 39805 Tokyo Japan
    1521 Site Reference ID/Investigator# 39807 Tokyo Japan
    1522 Site Reference ID/Investigator# 39808 Tokyo Japan
    1523 Site Reference ID/Investigator# 39811 Tokyo Japan
    1524 Site Reference ID/Investigator# 39812 Tokyo Japan
    1525 Site Reference ID/Investigator# 39813 Tokyo Japan
    1526 Site Reference ID/Investigator# 39815 Tokyo Japan
    1527 Site Reference ID/Investigator# 39816 Tokyo Japan
    1528 Site Reference ID/Investigator# 39818 Tokyo Japan
    1529 Site Reference ID/Investigator# 39819 Tokyo Japan
    1530 Site Reference ID/Investigator# 39820 Tokyo Japan
    1531 Site Reference ID/Investigator# 39821 Tokyo Japan
    1532 Site Reference ID/Investigator# 39822 Tokyo Japan
    1533 Site Reference ID/Investigator# 39823 Tokyo Japan
    1534 Site Reference ID/Investigator# 39824 Tokyo Japan
    1535 Site Reference ID/Investigator# 39825 Tokyo Japan
    1536 Site Reference ID/Investigator# 39826 Tokyo Japan
    1537 Site Reference ID/Investigator# 39827 Tokyo Japan
    1538 Site Reference ID/Investigator# 39828 Tokyo Japan
    1539 Site Reference ID/Investigator# 39829 Tokyo Japan
    1540 Site Reference ID/Investigator# 39830 Tokyo Japan
    1541 Site Reference ID/Investigator# 39831 Tokyo Japan
    1542 Site Reference ID/Investigator# 39832 Tokyo Japan
    1543 Site Reference ID/Investigator# 39833 Tokyo Japan
    1544 Site Reference ID/Investigator# 39834 Tokyo Japan
    1545 Site Reference ID/Investigator# 39835 Tokyo Japan
    1546 Site Reference ID/Investigator# 39836 Tokyo Japan
    1547 Site Reference ID/Investigator# 39837 Tokyo Japan
    1548 Site Reference ID/Investigator# 39838 Tokyo Japan
    1549 Site Reference ID/Investigator# 39894 Tokyo Japan
    1550 Site Reference ID/Investigator# 39895 Tokyo Japan
    1551 Site Reference ID/Investigator# 39896 Tokyo Japan
    1552 Site Reference ID/Investigator# 39897 Tokyo Japan
    1553 Site Reference ID/Investigator# 39898 Tokyo Japan
    1554 Site Reference ID/Investigator# 39899 Tokyo Japan
    1555 Site Reference ID/Investigator# 39900 Tokyo Japan
    1556 Site Reference ID/Investigator# 39902 Tokyo Japan
    1557 Site Reference ID/Investigator# 39903 Tokyo Japan
    1558 Site Reference ID/Investigator# 39904 Tokyo Japan
    1559 Site Reference ID/Investigator# 39905 Tokyo Japan
    1560 Site Reference ID/Investigator# 39906 Tokyo Japan
    1561 Site Reference ID/Investigator# 39907 Tokyo Japan
    1562 Site Reference ID/Investigator# 39908 Tokyo Japan
    1563 Site Reference ID/Investigator# 39909 Tokyo Japan
    1564 Site Reference ID/Investigator# 39911 Tokyo Japan
    1565 Site Reference ID/Investigator# 39923 Tokyo Japan
    1566 Site Reference ID/Investigator# 39927 Tokyo Japan
    1567 Site Reference ID/Investigator# 42718 Tokyo Japan
    1568 Site Reference ID/Investigator# 42722 Tokyo Japan
    1569 Site Reference ID/Investigator# 42741 Tokyo Japan
    1570 Site Reference ID/Investigator# 42742 Tokyo Japan
    1571 Site Reference ID/Investigator# 42749 Tokyo Japan
    1572 Site Reference ID/Investigator# 42792 Tokyo Japan
    1573 Site Reference ID/Investigator# 42795 Tokyo Japan
    1574 Site Reference ID/Investigator# 42796 Tokyo Japan
    1575 Site Reference ID/Investigator# 42800 Tokyo Japan
    1576 Site Reference ID/Investigator# 42860 Tokyo Japan
    1577 Site Reference ID/Investigator# 42861 Tokyo Japan
    1578 Site Reference ID/Investigator# 42862 Tokyo Japan
    1579 Site Reference ID/Investigator# 42863 Tokyo Japan
    1580 Site Reference ID/Investigator# 42864 Tokyo Japan
    1581 Site Reference ID/Investigator# 42865 Tokyo Japan
    1582 Site Reference ID/Investigator# 42891 Tokyo Japan
    1583 Site Reference ID/Investigator# 58545 Tokyo Japan
    1584 Site Reference ID/Investigator# 58606 Tokyo Japan
    1585 Site Reference ID/Investigator# 58610 Tokyo Japan
    1586 Site Reference ID/Investigator# 58659 Tokyo Japan
    1587 Site Reference ID/Investigator# 58660 Tokyo Japan
    1588 Site Reference ID/Investigator# 58661 Tokyo Japan
    1589 Site Reference ID/Investigator# 58662 Tokyo Japan
    1590 Site Reference ID/Investigator# 58663 Tokyo Japan
    1591 Site Reference ID/Investigator# 58664 Tokyo Japan
    1592 Site Reference ID/Investigator# 58665 Tokyo Japan
    1593 Site Reference ID/Investigator# 58666 Tokyo Japan
    1594 Site Reference ID/Investigator# 58667 Tokyo Japan
    1595 Site Reference ID/Investigator# 58789 Tokyo Japan
    1596 Site Reference ID/Investigator# 58790 Tokyo Japan
    1597 Site Reference ID/Investigator# 58798 Tokyo Japan
    1598 Site Reference ID/Investigator# 58804 Tokyo Japan
    1599 Site Reference ID/Investigator# 58807 Tokyo Japan
    1600 Site Reference ID/Investigator# 58809 Tokyo Japan
    1601 Site Reference ID/Investigator# 58828 Tokyo Japan
    1602 Site Reference ID/Investigator# 58829 Tokyo Japan
    1603 Site Reference ID/Investigator# 58830 Tokyo Japan
    1604 Site Reference ID/Investigator# 36170 Tottori Japan
    1605 Site Reference ID/Investigator# 36661 Tottori Japan
    1606 Site Reference ID/Investigator# 36806 Tottori Japan
    1607 Site Reference ID/Investigator# 36916 Tottori Japan
    1608 Site Reference ID/Investigator# 39919 Tottori Japan
    1609 Site Reference ID/Investigator# 39921 Tottori Japan
    1610 Site Reference ID/Investigator# 39922 Tottori Japan
    1611 Site Reference ID/Investigator# 39925 Tottori Japan
    1612 Site Reference ID/Investigator# 39926 Tottori Japan
    1613 Site Reference ID/Investigator# 42721 Tottori Japan
    1614 Site Reference ID/Investigator# 36309 Toyama Japan
    1615 Site Reference ID/Investigator# 36310 Toyama Japan
    1616 Site Reference ID/Investigator# 36311 Toyama Japan
    1617 Site Reference ID/Investigator# 36312 Toyama Japan
    1618 Site Reference ID/Investigator# 36313 Toyama Japan
    1619 Site Reference ID/Investigator# 36314 Toyama Japan
    1620 Site Reference ID/Investigator# 36315 Toyama Japan
    1621 Site Reference ID/Investigator# 36316 Toyama Japan
    1622 Site Reference ID/Investigator# 36443 Toyama Japan
    1623 Site Reference ID/Investigator# 36564 Toyama Japan
    1624 Site Reference ID/Investigator# 36807 Toyama Japan
    1625 Site Reference ID/Investigator# 36938 Toyama Japan
    1626 Site Reference ID/Investigator# 39920 Toyama Japan
    1627 Site Reference ID/Investigator# 39924 Toyama Japan
    1628 Site Reference ID/Investigator# 39928 Toyama Japan
    1629 Site Reference ID/Investigator# 39929 Toyama Japan
    1630 Site Reference ID/Investigator# 39930 Toyama Japan
    1631 Site Reference ID/Investigator# 39933 Toyama Japan
    1632 Site Reference ID/Investigator# 39935 Toyama Japan
    1633 Site Reference ID/Investigator# 42793 Toyama Japan
    1634 Site Reference ID/Investigator# 42797 Toyama Japan
    1635 Site Reference ID/Investigator# 42799 Toyama Japan
    1636 Site Reference ID/Investigator# 42927 Toyama Japan
    1637 Site Reference ID/Investigator# 58583 Toyama Japan
    1638 Site Reference ID/Investigator# 58817 Toyama Japan
    1639 Site Reference ID/Investigator# 58856 Toyama Japan
    1640 Site Reference ID/Investigator# 58873 Toyama Japan
    1641 Site Reference ID/Investigator# 36866 Toyohashi Japan
    1642 Site Reference ID/Investigator# 42713 Tsuyama Japan
    1643 Site Reference ID/Investigator# 39308 Tsu Japan
    1644 Site Reference ID/Investigator# 36317 Wakayama Japan
    1645 Site Reference ID/Investigator# 36318 Wakayama Japan
    1646 Site Reference ID/Investigator# 36319 Wakayama Japan
    1647 Site Reference ID/Investigator# 36320 Wakayama Japan
    1648 Site Reference ID/Investigator# 36321 Wakayama Japan
    1649 Site Reference ID/Investigator# 36578 Wakayama Japan
    1650 Site Reference ID/Investigator# 39931 Wakayama Japan
    1651 Site Reference ID/Investigator# 39932 Wakayama Japan
    1652 Site Reference ID/Investigator# 39936 Wakayama Japan
    1653 Site Reference ID/Investigator# 42737 Wakayama Japan
    1654 Site Reference ID/Investigator# 42906 Wakayama Japan
    1655 Site Reference ID/Investigator# 58568 Wakayama Japan
    1656 Site Reference ID/Investigator# 58787 Wakayama Japan
    1657 Site Reference ID/Investigator# 36592 Yamagata Japan
    1658 Site Reference ID/Investigator# 36833 Yamagata Japan
    1659 Site Reference ID/Investigator# 36935 Yamagata Japan
    1660 Site Reference ID/Investigator# 36952 Yamagata Japan
    1661 Site Reference ID/Investigator# 39934 Yamagata Japan
    1662 Site Reference ID/Investigator# 42873 Yamagata Japan
    1663 Site Reference ID/Investigator# 58599 Yamagata Japan
    1664 Site Reference ID/Investigator# 58648 Yamagata Japan
    1665 Site Reference ID/Investigator# 58649 Yamagata Japan
    1666 Site Reference ID/Investigator# 58650 Yamagata Japan
    1667 Site Reference ID/Investigator# 58821 Yamagata Japan
    1668 Site Reference ID/Investigator# 58822 Yamagata Japan
    1669 Site Reference ID/Investigator# 36322 Yamaguchi Japan
    1670 Site Reference ID/Investigator# 36323 Yamaguchi Japan
    1671 Site Reference ID/Investigator# 36324 Yamaguchi Japan
    1672 Site Reference ID/Investigator# 36325 Yamaguchi Japan
    1673 Site Reference ID/Investigator# 36583 Yamaguchi Japan
    1674 Site Reference ID/Investigator# 36595 Yamaguchi Japan
    1675 Site Reference ID/Investigator# 36662 Yamaguchi Japan
    1676 Site Reference ID/Investigator# 36797 Yamaguchi Japan
    1677 Site Reference ID/Investigator# 36904 Yamaguchi Japan
    1678 Site Reference ID/Investigator# 36917 Yamaguchi Japan
    1679 Site Reference ID/Investigator# 39937 Yamaguchi Japan
    1680 Site Reference ID/Investigator# 39938 Yamaguchi Japan
    1681 Site Reference ID/Investigator# 39939 Yamaguchi Japan
    1682 Site Reference ID/Investigator# 39940 Yamaguchi Japan
    1683 Site Reference ID/Investigator# 39941 Yamaguchi Japan
    1684 Site Reference ID/Investigator# 39942 Yamaguchi Japan
    1685 Site Reference ID/Investigator# 39943 Yamaguchi Japan
    1686 Site Reference ID/Investigator# 39944 Yamaguchi Japan
    1687 Site Reference ID/Investigator# 39945 Yamaguchi Japan
    1688 Site Reference ID/Investigator# 39947 Yamaguchi Japan
    1689 Site Reference ID/Investigator# 39949 Yamaguchi Japan
    1690 Site Reference ID/Investigator# 39950 Yamaguchi Japan
    1691 Site Reference ID/Investigator# 39952 Yamaguchi Japan
    1692 Site Reference ID/Investigator# 39953 Yamaguchi Japan
    1693 Site Reference ID/Investigator# 39954 Yamaguchi Japan
    1694 Site Reference ID/Investigator# 42732 Yamaguchi Japan
    1695 Site Reference ID/Investigator# 42735 Yamaguchi Japan
    1696 Site Reference ID/Investigator# 42794 Yamaguchi Japan
    1697 Site Reference ID/Investigator# 42842 Yamaguchi Japan
    1698 Site Reference ID/Investigator# 42843 Yamaguchi Japan
    1699 Site Reference ID/Investigator# 58578 Yamaguchi Japan
    1700 Site Reference ID/Investigator# 58714 Yamaguchi Japan
    1701 Site Reference ID/Investigator# 58808 Yamaguchi Japan
    1702 Site Reference ID/Investigator# 58863 Yamaguchi Japan
    1703 Site Reference ID/Investigator# 58864 Yamaguchi Japan
    1704 Site Reference ID/Investigator# 36695 Yamanashi Japan
    1705 Site Reference ID/Investigator# 39951 Yamanashi Japan
    1706 Site Reference ID/Investigator# 39955 Yamanashi Japan
    1707 Site Reference ID/Investigator# 39956 Yamanashi Japan
    1708 Site Reference ID/Investigator# 39957 Yamanashi Japan
    1709 Site Reference ID/Investigator# 39958 Yamanashi Japan
    1710 Site Reference ID/Investigator# 39959 Yamanashi Japan
    1711 Site Reference ID/Investigator# 39960 Yamanashi Japan
    1712 Site Reference ID/Investigator# 39961 Yamanashi Japan
    1713 Site Reference ID/Investigator# 39962 Yamanashi Japan
    1714 Site Reference ID/Investigator# 39963 Yamanashi Japan
    1715 Site Reference ID/Investigator# 58827 Yamanashi Japan
    1716 Site Reference ID/Investigator# 36239 Yokohama Japan
    1717 Site Reference ID/Investigator# 39701 Yokohama Japan
    1718 Site Reference ID/Investigator# 39702 Yokohama Japan
    1719 Site Reference ID/Investigator# 39703 Yokohama Japan
    1720 Site Reference ID/Investigator# 39704 Yokohama Japan
    1721 Site Reference ID/Investigator# 39715 Yokohama Japan
    1722 Site Reference ID/Investigator# 39357 Yufu Japan
    1723 Site Reference ID/Investigator# 39358 Yufu Japan

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Toshiro Maeda, Abbott Japan Co.,Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott
    ClinicalTrials.gov Identifier:
    NCT01076959
    Other Study ID Numbers:
    • P10-559
    First Posted:
    Feb 26, 2010
    Last Update Posted:
    Aug 28, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Abbott
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the Pharmaceuticals and Medical Devices Agency (PMDA).
    Pre-assignment Detail The study was completed when the PMDA had completed their review. A total of 7972 patients were registered and case report forms were retrieved for 7891 patients; 151 patients were excluded from the analysis because the case report forms were either duplicated (n=150) or the patient was included in another survey (n=1).
    Arm/Group Title Humira
    Arm/Group Description Patients who received Humira for 24 weeks during the PMDA review period.
    Period Title: Overall Study
    STARTED 7740
    COMPLETED 5490
    NOT COMPLETED 2250

    Baseline Characteristics

    Arm/Group Title Humira
    Arm/Group Description Patients who received Humira for 24 weeks during the PMDA review period.
    Overall Participants 7740
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60.1
    (13.0)
    Age, Customized (participants) [Number]
    <20 years
    26
    0.3%
    >=20-<30
    165
    2.1%
    >=30-<40
    461
    6%
    >=40-<50
    828
    10.7%
    >=50-<60
    1803
    23.3%
    >=60-<70
    2515
    32.5%
    >=70-<80
    1676
    21.7%
    >=80-<90
    261
    3.4%
    >=90
    4
    0.1%
    No data
    1
    0%
    Sex: Female, Male (Count of Participants)
    Female
    6388
    82.5%
    Male
    1352
    17.5%
    Region of Enrollment (participants) [Number]
    Japan
    7740
    100%

    Outcome Measures

    1. Primary Outcome
    Title Total Number of Patients With Adverse Events
    Description Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.
    Time Frame Baseline to Week 24

    Outcome Measure Data

    Analysis Population Description
    The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.
    Arm/Group Title Humira
    Arm/Group Description Patients who received Humira for 24 weeks during the PMDA review period.
    Measure Participants 7740
    Number [Percentage of Patients]
    27.8
    2. Secondary Outcome
    Title Physicians' Overall Effectiveness Response Rating
    Description Physicians' rated the level of overall patient improvement as "markedly improved," "improved," "not changed," or "not assessable" by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
    Arm/Group Title Physician Response Rating
    Arm/Group Description The full analysis set was used to determine the physicians' overall response rating.
    Measure Participants 6802
    Markedly Improved
    29.1
    Improved
    45.2
    Not Changed
    19.6
    Not Assessable
    6.1
    3. Primary Outcome
    Title Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4
    Description Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
    Arm/Group Title Humira - Good Response Humira - Moderate Response Humira - No Response Effective Rate-Sum of Patients With Good or Moderate Response
    Arm/Group Description Patients who received Humira during the PMDA review period and had a good response according to DAS 28 (improvement > 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement <0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
    Measure Participants 3341 3341 3341 3341
    Number [Percentage of patients]
    20.4
    45.7
    33.9
    66.1
    4. Primary Outcome
    Title Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12
    Description Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
    Arm/Group Title Humira - Good Response Humira - Moderate Response Humira - No Response Effective Rate-Sum of Patients With Good or Moderate Response
    Arm/Group Description Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
    Measure Participants 3927 3927 3927 3927
    Number [percentage of patients]
    26.4
    42.6
    31.1
    68.9
    5. Primary Outcome
    Title Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24
    Description Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
    Arm/Group Title Humira - Good Response Humira - Moderate Response Humira - No Response Effective Rate-Sum of Patients With Good and Moderate Response
    Arm/Group Description Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 4.at Week 24. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 24. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included. Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
    Measure Participants 4410 4410 4410 4410
    Number [Percentage of Patients]
    30.7
    39.3
    29.9
    70.1

    Adverse Events

    Time Frame Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
    Adverse Event Reporting Description
    Arm/Group Title Humira
    Arm/Group Description Patients who received Humira for 24 weeks during the PMDA review period.
    All Cause Mortality
    Humira
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Humira
    Affected / at Risk (%) # Events
    Total 469/7740 (6.1%)
    Blood and lymphatic system disorders
    Agranulocytosis 1/7740 (0%)
    Anemia 4/7740 (0.1%)
    Anemia folate deficiency 1/7740 (0%)
    Disseminated intravascular coagulation 3/7740 (0%)
    Lymphadenitis 2/7740 (0%)
    Lymphadenopathy 1/7740 (0%)
    Pancytopenia 5/7740 (0.1%)
    Thrombocytopenia 4/7740 (0.1%)
    Bone Marrow Failure 1/7740 (0%)
    Cardiac disorders
    Acute myocardial infarction 5/7740 (0.1%)
    Angina pectoris 1/7740 (0%)
    Atrial fibrillation 2/7740 (0%)
    Atrial tachycardia 1/7740 (0%)
    Cardiac failure 5/7740 (0.1%)
    Cardiac failure acute 1/7740 (0%)
    Cardiac failure congestive 1/7740 (0%)
    Pericardial effusion 2/7740 (0%)
    Right ventricular failure 1/7740 (0%)
    Sick sinus syndrome 1/7740 (0%)
    Ear and labyrinth disorders
    Deafness neurosensory 1/7740 (0%)
    Vertigo 1/7740 (0%)
    Eye disorders
    Retinal vein occlusion 1/7740 (0%)
    Scleritis 1/7740 (0%)
    Uveitis 1/7740 (0%)
    Visual impairment 1/7740 (0%)
    Gastrointestinal disorders
    Colitis ischemic 1/7740 (0%)
    Diarrhea 2/7740 (0%)
    Duodenal ulcer 1/7740 (0%)
    Enterocolitis 2/7740 (0%)
    Gastric ulcer 1/7740 (0%)
    Gastric ulcer hemorrhage 2/7740 (0%)
    Gastric ulcer perforation 1/7740 (0%)
    Gastritis atrophic 1/7740 (0%)
    Gastritis hemorrhagic 1/7740 (0%)
    Gastrointestinal hemorrhage 2/7740 (0%)
    Gastrointestinal necrosis 1/7740 (0%)
    Ileitis 1/7740 (0%)
    Ileus paralytic 1/7740 (0%)
    Intestinal obstruction 1/7740 (0%)
    Intestinal perforation 1/7740 (0%)
    Melena 2/7740 (0%)
    Esophageal ulcer 1/7740 (0%)
    Pancreatitis acute 2/7740 (0%)
    Peritonitis 1/7740 (0%)
    Small intestine ulcer 1/7740 (0%)
    Upper gastrointestinal hemorrhage 1/7740 (0%)
    Duodenal stenosis 1/7740 (0%)
    Pneumatosis intestinalis 1/7740 (0%)
    Diverticular perforation 1/7740 (0%)
    General disorders
    Chest pain 3/7740 (0%)
    Death 4/7740 (0.1%)
    Device breakage 1/7740 (0%)
    Drowning 1/7740 (0%)
    Gait disturbance 1/7740 (0%)
    Hyperthermia 1/7740 (0%)
    Local swelling 1/7740 (0%)
    Malaise 2/7740 (0%)
    Multiorgan failure 2/7740 (0%)
    Edema 1/7740 (0%)
    Edema peripheral 1/7740 (0%)
    Pyrexia 13/7740 (0.2%)
    Hepatobiliary disorders
    Cholecystitis 1/7740 (0%)
    Cholecystitis acute 2/7740 (0%)
    Hepatic failure 1/7740 (0%)
    Hepatic function abnormal 4/7740 (0.1%)
    Hepatitis 2/7740 (0%)
    Jaundice 1/7740 (0%)
    Liver disorder 2/7740 (0%)
    Gallbladder polyp 1/7740 (0%)
    Immune system disorders
    Anaphylactic reaction 1/7740 (0%)
    Anaphylactoid reaction 1/7740 (0%)
    Hypersensitivity 1/7740 (0%)
    Sarcoidosis 1/7740 (0%)
    Infections and infestations
    Bronchiolitis 1/7740 (0%)
    Bronchitis 3/7740 (0%)
    Bronchopneumonia 5/7740 (0.1%)
    Bronchopulmonary aspergillosis 1/7740 (0%)
    Cellulitis 12/7740 (0.2%)
    Cystitis 2/7740 (0%)
    Disseminated tuberculosis 1/7740 (0%)
    Endophthalmitis 1/7740 (0%)
    Erysipelas 1/7740 (0%)
    Gastroenteritis 4/7740 (0.1%)
    Hepatitis B 1/7740 (0%)
    Herpes zoster 12/7740 (0.2%)
    Infection 1/7740 (0%)
    Influenza 1/7740 (0%)
    Lymph node tuberculosis 1/7740 (0%)
    Meningitis 1/7740 (0%)
    Meningitis aseptic 2/7740 (0%)
    Nasopharyngitis 1/7740 (0%)
    Peritonsillar abscess 1/7740 (0%)
    Pharyngitis 1/7740 (0%)
    Pneumonia 41/7740 (0.5%)
    Pneumonia chlamydial 2/7740 (0%)
    Pneumonia cytomegaloviral 2/7740 (0%)
    Pneumonia legionella 3/7740 (0%)
    Pneumonia pneumococcal 2/7740 (0%)
    Postoperative wound infection 1/7740 (0%)
    Pseudomembranous colitis 1/7740 (0%)
    Pulmonary tuberculosis 3/7740 (0%)
    Pulpitis dental 1/7740 (0%)
    Pyelonephritis 4/7740 (0.1%)
    Pyelonephritis acute 1/7740 (0%)
    Pyothorax 2/7740 (0%)
    Rash pustular 2/7740 (0%)
    Sepsis 13/7740 (0.2%)
    Septic shock 2/7740 (0%)
    Tonsillitis 1/7740 (0%)
    Tooth abscess 1/7740 (0%)
    Tuberculosis 1/7740 (0%)
    Tuberculous pleurisy 2/7740 (0%)
    Urinary tract infection 4/7740 (0.1%)
    Muscle abscess 2/7740 (0%)
    Abscess limb 2/7740 (0%)
    Arthritis bacterial 7/7740 (0.1%)
    Peritoneal tuberculosis 1/7740 (0%)
    Psoas abscess 1/7740 (0%)
    Wound abscess 1/7740 (0%)
    Pneumonia bacterial 13/7740 (0.2%)
    Bursitis infective 2/7740 (0%)
    Lung infection 1/7740 (0%)
    Tuberculosis gastrointestinal 1/7740 (0%)
    Atypical mycobacterial infection 1/7740 (0%)
    Enterocolitis viral 1/7740 (0%)
    Purulence 1/7740 (0%)
    Mycobacterial infection 1/7740 (0%)
    Pneumocystis jiroveci pneumonia 26/7740 (0.3%)
    Device related infection 1/7740 (0%)
    Enterocolitis bacterial 1/7740 (0%)
    Post procedural infection 1/7740 (0%)
    Pneumonia cryptococcal 2/7740 (0%)
    Injury, poisoning and procedural complications
    Compression fracture 2/7740 (0%)
    Fall 3/7740 (0%)
    Femoral neck fracture 10/7740 (0.1%)
    Femur fracture 5/7740 (0.1%)
    Fibula fracture 2/7740 (0%)
    Foot fracture 1/7740 (0%)
    Fracture 1/7740 (0%)
    Fractured sacrum 2/7740 (0%)
    Head injury 1/7740 (0%)
    Humerus fracture 2/7740 (0%)
    Pneumothorax traumatic 1/7740 (0%)
    Radius fracture 2/7740 (0%)
    Rib fracture 1/7740 (0%)
    Road traffic accident 1/7740 (0%)
    Spinal compression fracture 6/7740 (0.1%)
    Subdural hematoma 1/7740 (0%)
    Tendon rupture 6/7740 (0.1%)
    Tibia fracture 1/7740 (0%)
    Ulna fracture 1/7740 (0%)
    Contusion 3/7740 (0%)
    Joint injury 1/7740 (0%)
    Pelvic fracture 3/7740 (0%)
    Upper limb fracture 1/7740 (0%)
    Periprosthetic fracture 1/7740 (0%)
    Pubis fracture 1/7740 (0%)
    Investigations
    Blood creatine phosphokinase increased 1/7740 (0%)
    Blood glucose decreased 1/7740 (0%)
    Blood glucose increased 1/7740 (0%)
    Blood pressure increased 1/7740 (0%)
    C-reactive protein increased 2/7740 (0%)
    Carcinoembryonic antigen increased 1/7740 (0%)
    Platelet count decreased 1/7740 (0%)
    White blood cell count decreased 1/7740 (0%)
    Blood beta-D-glucan abnormal 1/7740 (0%)
    Hepatic enzyme increased 1/7740 (0%)
    Cell marker increased 1/7740 (0%)
    Candida test positive 1/7740 (0%)
    Metabolism and nutrition disorders
    Diabetes mellitus 1/7740 (0%)
    Hyperglycemia 1/7740 (0%)
    Hypoglycemia 2/7740 (0%)
    Decreased appetite 2/7740 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 4/7740 (0.1%)
    Arthritis 2/7740 (0%)
    Arthropathy 1/7740 (0%)
    Back pain 5/7740 (0.1%)
    Bursitis 1/7740 (0%)
    Myalgia 1/7740 (0%)
    Myositis 1/7740 (0%)
    Polymyalgia rheumatic 1/7740 (0%)
    Polymyositis 3/7740 (0%)
    Rhabdomyolysis 1/7740 (0%)
    Scleroderma 1/7740 (0%)
    Spinal column stenosis 1/7740 (0%)
    Systemic lupus erythematosus 2/7740 (0%)
    Foot deformity 1/7740 (0%)
    Spondylolisthesis 1/7740 (0%)
    Atlantoaxial instability 1/7740 (0%)
    Rheumatoid arthritis 5/7740 (0.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bile duct cancer 1/7740 (0%)
    Bladder cancer recurrent 1/7740 (0%)
    Bone neoplasm 1/7740 (0%)
    Breast cancer recurrent 1/7740 (0%)
    Cervix carcinoma stage IV 1/7740 (0%)
    Colon cancer 1/7740 (0%)
    Gastric cancer 1/7740 (0%)
    Hepatic neoplasm malignant 1/7740 (0%)
    Laryngeal cancer 1/7740 (0%)
    Lung carcinoma cell type unspecified recurrent 1/7740 (0%)
    Lung squamous cell carcinoma stage unspecified 2/7740 (0%)
    Malignant ascites 1/7740 (0%)
    Meningioma 1/7740 (0%)
    Non-Hodgkin's Lymphoma 1/7740 (0%)
    Rectal cancer 1/7740 (0%)
    Squamous cell carcinoma of the cervix 1/7740 (0%)
    Tongue neoplasm malignant stage unspecified 1/7740 (0%)
    Tumour embolism 1/7740 (0%)
    Gallbladder cancer stage IV 1/7740 (0%)
    Large intestine carcinoma 1/7740 (0%)
    Prostate cancer 1/7740 (0%)
    Salivary gland neoplasm 1/7740 (0%)
    Ovarian neoplasm 1/7740 (0%)
    Metastatis 1/7740 (0%)
    Nervous system disorders
    Amnesia 1/7740 (0%)
    Cauda equina syndrome 1/7740 (0%)
    Cerebellar infarction 1/7740 (0%)
    Cerebral hemorrhage 3/7740 (0%)
    Cerebral thrombosis 1/7740 (0%)
    Cerebrovascular accident 1/7740 (0%)
    Cerebrovascular disorder 1/7740 (0%)
    Demyelination 1/7740 (0%)
    Nervous system disorder 1/7740 (0%)
    Optic neuritis 1/7740 (0%)
    Sciatica 1/7740 (0%)
    Subarachnoid hemorrhage 5/7740 (0.1%)
    Syncope 1/7740 (0%)
    Transient ischaemic attack 1/7740 (0%)
    Putamen hemorrhage 1/7740 (0%)
    Thrombotic cerebral infarction 1/7740 (0%)
    Cerebral infarction 4/7740 (0.1%)
    Psychiatric disorders
    Completed suicide 2/7740 (0%)
    Insomnia 1/7740 (0%)
    Renal and urinary disorders
    Calculus ureteric 1/7740 (0%)
    Nephrotic syndrome 1/7740 (0%)
    Renal failure 1/7740 (0%)
    Renal failure acute 3/7740 (0%)
    Renal impairment 2/7740 (0%)
    Henoch-Schonlein purpura nephritis 1/7740 (0%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/7740 (0%)
    Cough 1/7740 (0%)
    Dyspnea 4/7740 (0.1%)
    Interstitial lung disease 40/7740 (0.5%)
    Lung disorder 1/7740 (0%)
    Pleural effusion 4/7740 (0.1%)
    Pleurisy 3/7740 (0%)
    Pneumonia aspiration 1/7740 (0%)
    Pulmonary embolism 1/7740 (0%)
    Pulmonary edema 1/7740 (0%)
    Respiratory failure 4/7740 (0.1%)
    Rheumatoid lung 1/7740 (0%)
    Diffuse panbronchiolitis 1/7740 (0%)
    Organising pneumonia 5/7740 (0.1%)
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform 1/7740 (0%)
    Dermatitis allergic 1/7740 (0%)
    Dermatomyositis 1/7740 (0%)
    Drug eruption 2/7740 (0%)
    Eczema 1/7740 (0%)
    Erythema 2/7740 (0%)
    Leukocytoclastic vasculitis 1/7740 (0%)
    Rash 4/7740 (0.1%)
    Rash erythematosus 1/7740 (0%)
    Rash generalized 2/7740 (0%)
    Skin necrosis 1/7740 (0%)
    Skin ulcer 1/7740 (0%)
    Stevens-Johnson syndrome 1/7740 (0%)
    Urticaria 1/7740 (0%)
    Generalized erythema 1/7740 (0%)
    Toxic skin eruption 1/7740 (0%)
    Dermatitis psoriasiform 1/7740 (0%)
    Vascular disorders
    Aortic aneurysm 1/7740 (0%)
    Aortic dissection 1/7740 (0%)
    Hypotension 1/7740 (0%)
    Peripheral circulatory failure 1/7740 (0%)
    Shock 1/7740 (0%)
    Vasculitis 1/7740 (0%)
    Vasculitis necrotizing 1/7740 (0%)
    Deep vein thrombosis 2/7740 (0%)
    Arterial hemorrhage 1/7740 (0%)
    Other (Not Including Serious) Adverse Events
    Humira
    Affected / at Risk (%) # Events
    Total 863/7740 (11.1%)
    General disorders
    Injection site erythema 160/7740 (2.1%)
    Injection site reaction 108/7740 (1.4%)
    Pyrexia 99/7740 (1.3%)
    Hepatobiliary disorders
    Hepatic function abnormal 110/7740 (1.4%)
    Infections and infestations
    Nasopharyngitis 94/7740 (1.2%)
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation 79/7740 (1%)
    Skin and subcutaneous tissue disorders
    Pruritus 78/7740 (1%)
    Rash 255/7740 (3.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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
    Email
    Responsible Party:
    Abbott
    ClinicalTrials.gov Identifier:
    NCT01076959
    Other Study ID Numbers:
    • P10-559
    First Posted:
    Feb 26, 2010
    Last Update Posted:
    Aug 28, 2012
    Last Verified:
    Aug 1, 2012