Clincosm LogoSign in Get a demo

ReAlise: Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00234884
Collaborator
(none)
3,435
Enrollment
311
Locations
82
Duration (Months)
11
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

Condition or Disease Intervention/Treatment Phase
  • Biological: adalimumab

Detailed Description

This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448383 (Study M02-497), an interventional study that ended when adalimumab became commercially available for the treatment of RA. Participants had to have been receiving ongoing adalimumab treatment at the time NCT00448383 (Study M02-497) ended and been prescribed commercial adalimumab, and could have received commercial adalimumab for up to 1 year afterward prior to enrollment in NCT00234884 (Study M03-634).

Physician investigators were encouraged to treat participants as they would any other patient with RA in their routine clinical practice, and were free to determine the appropriate therapy for each patient. Concomitant treatment with disease-modifying antirheumatic drugs (DMARDs), including methotrexate, could be continued while receiving adalimumab. If treatment with adalimumab was permanently discontinued for any reason, participants were discontinued from the study and the reason was recorded. Investigators were asked to record adverse events up to 3 months after last administration of adalimumab.

Study Design

Study Type:
Observational
Actual Enrollment :
3435 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira
Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Adalimumab

RA patients in treatment with commercial adalimumab

Biological: adalimumab
commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)
Other Names:
  • HUMIRA®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) [Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

      DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.

    2. American College of Rheumatology 20% (ACR20) Response Rate [Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

      ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

    3. American College of Rheumatology 50% (ACR50) Response Rate [Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

      ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

    4. American College of Rheumatology 70% (ACR70) Response Rate [Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

      ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

    5. Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) [Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

      HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit
    1. of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
    • Participants must have been willing to consent to data being collected and provided to Abbott.
    Exclusion Criteria:

    · Participants with contraindications according to the SmPC.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Ref # / Investigator 5606 Camperdown New South Wales Australia 2050
    2 Site Ref # / Investigator 49504 New Lambton New South Wales Australia 2305
    3 Site Ref # / Investigator 49508 Brisbane Queensland Australia 4102
    4 Site Ref # / Investigator 49505 Woodville South Australia Australia 5011
    5 Site Ref # / Investigator 49503 West Heidelberg Victoria Australia 3081
    6 Site Ref # / Investigator 49502 Cairns Australia 4870
    7 Site Ref # / Investigator 49747 Bad Schallerbach Austria 4701
    8 Site Ref # / Investigator 49517 Graz Austria 8036
    9 Site Ref # / Investigator 49521 Graz Austria A-8020
    10 Site Ref # / Investigator 49518 Innsbruck Austria A-6020
    11 Site Ref # / Investigator 49746 Klagenfurt Austria 9020
    12 Site Ref # / Investigator 49748 Laab im Walde Austria 2381
    13 Site Ref # / Investigator 49516 Linz Austria 4020
    14 Site Ref # / Investigator 49523 Oberpullendorf Austria 7350
    15 Site Ref # / Investigator 49745 St. Poelten Austria 3100
    16 Site Ref # / Investigator 49519 Stockerau Austria 2000
    17 Site Ref # / Investigator 49520 Vienna Austria 1090
    18 Site Ref # / Investigator 4961 Vienna Austria 1130
    19 Site Ref # / Investigator 49794 Aalst Belgium 9300
    20 Site Ref # / Investigator 49817 Antwerp Belgium 2020
    21 Site Ref # / Investigator 49788 Assebroek Belgium 8310
    22 Site Ref # / Investigator 49764 Baudour Belgium 7331
    23 Site Ref # / Investigator 49808 Belsele Belgium 9111
    24 Site Ref # / Investigator 49806 Bonheiden Belgium 2820
    25 Site Ref # / Investigator 49809 Bonheiden Belgium 2820
    26 Site Ref # / Investigator 49798 Braine-l'Alleud Belgium 1421
    27 Site Ref # / Investigator 49773 Bruges Belgium 8000
    28 Site Ref # / Investigator 49774 Brussels Belgium 1000
    29 Site Ref # / Investigator 49763 Brussels Belgium 1020
    30 Site Ref # / Investigator 49791 Brussels Belgium 1050
    31 Site Ref # / Investigator 49762 Brussels Belgium 1070
    32 Site Ref # / Investigator 49811 Brussels Belgium 1090
    33 Site Ref # / Investigator 49807 Brussels Belgium 1180
    34 Site Ref # / Investigator 49772 Brussels Belgium 1200
    35 Site Ref # / Investigator 49780 Chimay Belgium 6460
    36 Site Ref # / Investigator 49795 Destelbergen Belgium 9070
    37 Site Ref # / Investigator 49768 Edegem Belgium 2650
    38 Site Ref # / Investigator 49776 Genk Belgium 3600
    39 Site Ref # / Investigator 49813 Genk Belgium 3600
    40 Site Ref # / Investigator 26424 Ghent Belgium 9000
    41 Site Ref # / Investigator 49766 Gosselies Belgium 6041
    42 Site Ref # / Investigator 49781 Hamme Belgium 9220
    43 Site Ref # / Investigator 49814 Hasselt Belgium 3500
    44 Site Ref # / Investigator 49810 Hasselt Belgium B-3500
    45 Site Ref # / Investigator 49777 Kortrijk Belgium 8500
    46 Site Ref # / Investigator 49767 La Louviere Belgium 7100
    47 Site Ref # / Investigator 49801 La Louviere Belgium 7100
    48 Site Ref # / Investigator 49816 Leuven Belgium 3000
    49 Site Ref # / Investigator 49789 Liege Belgium 4000
    50 Site Ref # / Investigator 49775 Lier Belgium 2500
    51 Site Ref # / Investigator 49778 Lokeren Belgium 9160
    52 Site Ref # / Investigator 49771 Mechelen Belgium 2800
    53 Site Ref # / Investigator 49815 Mechelen Belgium 2800
    54 Site Ref # / Investigator 49796 Merksem Belgium 2170
    55 Site Ref # / Investigator 49785 Mons Belgium 7000
    56 Site Ref # / Investigator 49891 Montignies-sur-Sambre Belgium 6061
    57 Site Ref # / Investigator 49770 Namur Belgium 5000
    58 Site Ref # / Investigator 49783 Namur Belgium 5000
    59 Site Ref # / Investigator 49797 Nukerke Belgium 9681
    60 Site Ref # / Investigator 49787 Oostende Belgium 8400
    61 Site Ref # / Investigator 49802 Ottignies Belgium 1340
    62 Site Ref # / Investigator 49793 Sijsele Belgium 8340
    63 Site Ref # / Investigator 49805 Sint-Niklaas Belgium 9100
    64 Site Ref # / Investigator 49615 Aix en Provence France 13616
    65 Site Ref # / Investigator 49332 Aix Les Bains France 73106
    66 Site Ref # / Investigator 49350 Angers France 49033
    67 Site Ref # / Investigator 49604 Aulnay Sous Bois France 93602
    68 Site Ref # / Investigator 49340 Belfort France 90016
    69 Site Ref # / Investigator 49621 Berck France 62608
    70 Site Ref # / Investigator 49339 Besancon France 25030
    71 Site Ref # / Investigator 49351 Bobigny France 93009
    72 Site Ref # / Investigator 49365 Bordeaux France 33076
    73 Site Ref # / Investigator 49611 Boulogne Billancourt France 92100
    74 Site Ref # / Investigator 49622 Bourg en Bresse France 01012
    75 Site Ref # / Investigator 49329 Brest France 29609
    76 Site Ref # / Investigator 49334 Caen France 14033
    77 Site Ref # / Investigator 49358 Cahors France 46005
    78 Site Ref # / Investigator 49607 Cannes France 06400
    79 Site Ref # / Investigator 49612 Carcassonne France 11012
    80 Site Ref # / Investigator 49628 Cherbourg France 50102
    81 Site Ref # / Investigator 49613 Clermont-Ferrand France 63003
    82 Site Ref # / Investigator 49624 Colombes France 92701
    83 Site Ref # / Investigator 49376 Compiegne France 60200
    84 Site Ref # / Investigator 49356 Corbeil Essonnes France 91108
    85 Site Ref # / Investigator 49370 Creteil France 94010
    86 Site Ref # / Investigator 49605 Dijon France 21033
    87 Site Ref # / Investigator 49608 Gleize France 69400
    88 Site Ref # / Investigator 49610 Gonesse France 95503
    89 Site Ref # / Investigator 49379 Grenoble France 38000
    90 Site Ref # / Investigator 49361 Grenoble France 38042
    91 Site Ref # / Investigator 49614 La Roche sur Yon France 85925
    92 Site Ref # / Investigator 49601 La Rochelle France 17019
    93 Site Ref # / Investigator 49373 Le Kremlin Bicetre France 94275
    94 Site Ref # / Investigator 49375 Le Mans France 72037
    95 Site Ref # / Investigator 49325 Libourne France 33505
    96 Site Ref # / Investigator 49620 Lievin France 62806
    97 Site Ref # / Investigator 49360 Lille France 59037
    98 Site Ref # / Investigator 49623 Limoges France 87042
    99 Site Ref # / Investigator 49333 Lomme France 59462
    100 Site Ref # / Investigator 49355 Lunel France 34400
    101 Site Ref # / Investigator 49337 Lyon France 69310
    102 Site Ref # / Investigator 49363 Lyon France 69365
    103 Site Ref # / Investigator 49364 Lyon France 69437
    104 Site Ref # / Investigator 49603 Mantes La Jolie France 78201
    105 Site Ref # / Investigator 49626 Marseilles France 13274
    106 Site Ref # / Investigator 49342 Marseilles France 13285
    107 Site Ref # / Investigator 49345 Marseilles France 13385
    108 Site Ref # / Investigator 49362 Marseilles France 13385
    109 Site Ref # / Investigator 49330 Montivilliers France 76290
    110 Site Ref # / Investigator 49323 Montpellier Cedex 5 France 34295
    111 Site Ref # / Investigator 5590 Mulhouse France 68070
    112 Site Ref # / Investigator 49374 Nantes Cedex 1 France 44035
    113 Site Ref # / Investigator 49642 Narbonne France 11108
    114 Site Ref # / Investigator 49353 Nice France 06200
    115 Site Ref # / Investigator 49618 Orange France 84106
    116 Site Ref # / Investigator 49331 Orleans France 45032
    117 Site Ref # / Investigator 49352 Paris Cedex 14 France 75679
    118 Site Ref # / Investigator 49326 Paris France 75014
    119 Site Ref # / Investigator 49600 Paris France 75016
    120 Site Ref # / Investigator 49625 Paris France 75475
    121 Site Ref # / Investigator 49359 Paris France 75651
    122 Site Ref # / Investigator 49343 Pau France 64046
    123 Site Ref # / Investigator 49344 Pessac France 33604
    124 Site Ref # / Investigator 49606 Pierre Benite France 69495
    125 Site Ref # / Investigator 49602 Poissy France 78303
    126 Site Ref # / Investigator 49349 Poitiers France 86021
    127 Site Ref # / Investigator 49627 Provins France 77488
    128 Site Ref # / Investigator 49382 Reims France 51100
    129 Site Ref # / Investigator 49328 Rennes France 35056
    130 Site Ref # / Investigator 49619 Roubaix France 59056
    131 Site Ref # / Investigator 49372 Rouen France 76031
    132 Site Ref # / Investigator 49609 Saint Aubin Les Elbeuf France 76410
    133 Site Ref # / Investigator 49327 Saint Brieuc France 22023
    134 Site Ref # / Investigator 49336 Saint Maurice France 94415
    135 Site Ref # / Investigator 49598 Saint-Etienne France 42055
    136 Site Ref # / Investigator 49346 Strasbourg France 67098
    137 Site Ref # / Investigator 49366 Thionville France 57126
    138 Site Ref # / Investigator 49616 Toulon France 83800
    139 Site Ref # / Investigator 49322 Toulouse France 31059
    140 Site Ref # / Investigator 49348 Toulouse France 31059
    141 Site Ref # / Investigator 49324 Tours France 37044
    142 Site Ref # / Investigator 49617 Valence France 26953
    143 Site Ref # / Investigator 49371 Valenciennes France 59322
    144 Site Ref # / Investigator 49629 Vannes France 56017
    145 Site Ref # / Investigator 49573 Aachen Germany 52064
    146 Site Ref # / Investigator 49454 Berlin Germany 12163
    147 Site Ref # / Investigator 49705 Berlin Germany 12627
    148 Site Ref # / Investigator 49480 Berlin Germany 14163
    149 Site Ref # / Investigator 49433 Berlin Germany D-10117
    150 Site Ref # / Investigator 49577 Bremen Germany 28209
    151 Site Ref # / Investigator 49451 Chemnitz Germany D-09130
    152 Site Ref # / Investigator 49551 Cologne Germany 50823
    153 Site Ref # / Investigator 5602 Cottbus Germany 3048
    154 Site Ref # / Investigator 49441 Damp Germany 24351
    155 Site Ref # / Investigator 49446 Dresden Germany 01277
    156 Site Ref # / Investigator 49474 Dresden Germany 01307
    157 Site Ref # / Investigator 49483 Duisburg Germany 47055
    158 Site Ref # / Investigator 49455 Erfurt Germany 99096
    159 Site Ref # / Investigator 49579 Erlangen Germany 91054
    160 Site Ref # / Investigator 49475 Erlangen Germany 91056
    161 Site Ref # / Investigator 49481 Essen Germany 45239
    162 Site Ref # / Investigator 49469 Freiburg Germany 79098
    163 Site Ref # / Investigator 49711 Freiburg Germany 79106
    164 Site Ref # / Investigator 49556 Fuerth Germany 90766
    165 Site Ref # / Investigator 49482 Gyhum Germany 27404
    166 Site Ref # / Investigator 49422 Halle Germany 06128
    167 Site Ref # / Investigator 49468 Hamburg Germany 20246
    168 Site Ref # / Investigator 49552 Hamburg Germany 22081
    169 Site Ref # / Investigator 49466 Hattingen Germany 45525
    170 Site Ref # / Investigator 49544 Herrsching Germany 82211
    171 Site Ref # / Investigator 49548 Hildesheim Germany 31134
    172 Site Ref # / Investigator 49587 Hofheim Germany 65719
    173 Site Ref # / Investigator 49447 Jena Germany 07747
    174 Site Ref # / Investigator 49431 Leipzig Germany 04207
    175 Site Ref # / Investigator 49424 Ludwigsburg Germany 71638
    176 Site Ref # / Investigator 49557 Ludwigshafen Germany 67065
    177 Site Ref # / Investigator 49704 Marl Germany 45770
    178 Site Ref # / Investigator 49547 Moenchengladbach Germany 41199
    179 Site Ref # / Investigator 49440 Muenster Germany 48129
    180 Site Ref # / Investigator 49450 Munich Germany 80331
    181 Site Ref # / Investigator 49563 Munich Germany 81667
    182 Site Ref # / Investigator 49442 Passau Germany 94032
    183 Site Ref # / Investigator 49549 Ratingen Germany 40882
    184 Site Ref # / Investigator 49708 Rostock Germany 18059
    185 Site Ref # / Investigator 49558 Schlangenbad Germany 65388
    186 Site Ref # / Investigator 49445 Sendenhorst Germany 48324
    187 Site Ref # / Investigator 49437 Stuttgart Germany 70178
    188 Site Ref # / Investigator 49560 Tuebingen Germany 72076
    189 Site Ref # / Investigator 49460 Villingen Germany 78054
    190 Site Ref # / Investigator 49456 Vogelsang-Gommern Germany 39245
    191 Site Ref # / Investigator 49545 Wuerzburg Germany 97070
    192 Site Ref # / Investigator 49449 Wuppertal Germany 42117
    193 Site Ref # / Investigator 49580 Athens Greece 10682
    194 Site Ref # / Investigator 49568 Athens Greece 11521
    195 Site Ref # / Investigator 49584 Athens Greece 11521
    196 Site Ref # / Investigator 49554 Athens Greece 11526
    197 Site Ref # / Investigator 49565 Athens Greece 11527
    198 Site Ref # / Investigator 49583 Athens Greece 11527
    199 Site Ref # / Investigator 49585 Athens Greece 14500
    200 Site Ref # / Investigator 49564 Heraklion Greece 81352
    201 Site Ref # / Investigator 49567 Ioannina Greece 45500
    202 Site Ref # / Investigator 49581 Larisa Greece 41110
    203 Site Ref # / Investigator 26425 Patras Greece 26500
    204 Site Ref # / Investigator 49566 Thessaloniki Greece 54625
    205 Site Ref # / Investigator 49582 Thessaloniki Greece 54636
    206 Site Ref # / Investigator 49553 Thessaloniki Greece 54642
    207 Site Ref # / Investigator 49569 Thessaloniki Greece 57010
    208 Site Ref # / Investigator 49990 Acqui Terme (AL) Italy 15011
    209 Site Ref # / Investigator 49591 Arenzano (GE) Italy 16011
    210 Site Ref # / Investigator 49983 Bari Italy 70124
    211 Site Ref # / Investigator 49593 Bologna Italy 40138
    212 Site Ref # / Investigator 49980 Brescia Italy 25123
    213 Site Ref # / Investigator 49986 Cagliari Italy 09042
    214 Site Ref # / Investigator 50056 Ferrara Italy 44100
    215 Site Ref # / Investigator 49987 Florence Italy 50100
    216 Site Ref # / Investigator 49597 Foggia Italy 71100
    217 Site Ref # / Investigator 49824 Genoa Italy 16132
    218 Site Ref # / Investigator 50051 Genoa Italy 16148
    219 Site Ref # / Investigator 49981 Jesi (Ancona) Italy 60035
    220 Site Ref # / Investigator 49588 Messina Italy 98125
    221 Site Ref # / Investigator 49976 Milano Italy 20122
    222 Site Ref # / Investigator 50052 Milano Italy 20132
    223 Site Ref # / Investigator 49596 Milano Italy 20162
    224 Site Ref # / Investigator 49985 Modena Italy 41100
    225 Site Ref # / Investigator 49949 Naples Italy 80135
    226 Site Ref # / Investigator 49595 Novara Italy 28100
    227 Site Ref # / Investigator 49947 Padova Italy 35128
    228 Site Ref # / Investigator 49948 Palermo Italy 90127
    229 Site Ref # / Investigator 49978 Perugia Italy 06126
    230 Site Ref # / Investigator 49974 Pescara Italy 65126
    231 Site Ref # / Investigator 49592 Pisa Italy 56126
    232 Site Ref # / Investigator 49992 Potenza Italy 85100
    233 Site Ref # / Investigator 49822 Prato Italy 59100
    234 Site Ref # / Investigator 49946 Reggio Emilia Italy 42100
    235 Site Ref # / Investigator 49989 Rome Italy 00152
    236 Site Ref # / Investigator 49950 Rome Italy 00161
    237 Site Ref # / Investigator 50057 Rome Italy 00168
    238 Site Ref # / Investigator 49984 Rozzano Italy 20089
    239 Site Ref # / Investigator 49991 San Cesario Lecce Italy 73016
    240 Site Ref # / Investigator 49994 Torino Italy 10128
    241 Site Ref # / Investigator 49825 Udine Italy 33100
    242 Site Ref # / Investigator 26422 Valeggio sul Mincio Verona Italy 37067
    243 Site Ref # / Investigator 49594 Varese Italy 21100
    244 Site Ref # / Investigator 50055 Verbania Pallanza Italy 28048
    245 Site Ref # / Investigator 49589 Verona Italy 37134
    246 Site Ref # / Investigator 50053 Vimercate Italy 20059
    247 Site Ref # / Investigator 49904 Alkmaar Netherlands 1815 JD
    248 Site Ref # / Investigator 49909 Almere Netherlands 1315 RA
    249 Site Ref # / Investigator 49831 Amersfoort Netherlands 3818 ES
    250 Site Ref # / Investigator 49906 Bergen op Zoom Netherlands 4624 VT
    251 Site Ref # / Investigator 49907 Breda Netherlands 4818 CK
    252 Site Ref # / Investigator 49905 Den Haag Netherlands 2545 CH
    253 Site Ref # / Investigator 49920 Den Haag Netherlands 2597 AX
    254 Site Ref # / Investigator 49910 Den Helder Netherlands 1780 AT
    255 Site Ref # / Investigator 49902 Goes Netherlands 4462 RA
    256 Site Ref # / Investigator 49829 Leeuwarden Netherlands 8934 AD
    257 Site Ref # / Investigator 26426 Rotterdam Netherlands 3015 GD
    258 Site Ref # / Investigator 49830 Rotterdam Netherlands 3078 HT
    259 Site Ref # / Investigator 49908 Schiedam Netherlands 3118 JH
    260 Site Ref # / Investigator 49827 Utrecht Netherlands GA 3508
    261 Site Ref # / Investigator 49903 Venlo Netherlands 5912 BL
    262 Site Ref # / Investigator 49835 Vlissingen Netherlands 4382 EE
    263 Site Ref # / Investigator 49514 Coimbra Portugal 3000-075
    264 Site Ref # / Investigator 49515 Lisboa Portugal 1050-034
    265 Site Ref # / Investigator 49509 Lisboa Portugal 1200
    266 Site Ref # / Investigator 49510 Lisbon Portugal 1349-019
    267 Site Ref # / Investigator 49513 Lisbon Portugal 1649-035
    268 Site Ref # / Investigator 49512 Ponta Delgada-Acores Portugal 9500-370
    269 Site Ref # / Investigator 26427 Ponte de Lima Portugal 4990-041
    270 Site Ref # / Investigator 49653 Alicante Spain 3010
    271 Site Ref # / Investigator 49662 Asturias Spain 33006
    272 Site Ref # / Investigator 49684 Barcelona Spain 08003
    273 Site Ref # / Investigator 49680 Barcelona Spain 08022
    274 Site Ref # / Investigator 49646 Barcelona Spain 08025
    275 Site Ref # / Investigator 49645 Barcelona Spain 08036
    276 Site Ref # / Investigator 49649 Barcelona Spain 08208
    277 Site Ref # / Investigator 49647 Barcelona Spain 08221
    278 Site Ref # / Investigator 49670 Barcelona Spain 08907
    279 Site Ref # / Investigator 49667 Cadiz Spain 11009
    280 Site Ref # / Investigator 49693 Cadiz Spain 11407
    281 Site Ref # / Investigator 5594 Castellon de la Plana Spain 12004
    282 Site Ref # / Investigator 49663 Cordoba Spain 14004
    283 Site Ref # / Investigator 49652 Elche Spain 32032
    284 Site Ref # / Investigator 49651 Granada Spain 18012
    285 Site Ref # / Investigator 49681 Granada Spain 18014
    286 Site Ref # / Investigator 49695 Guadalajara Spain 19002
    287 Site Ref # / Investigator 49669 Jaen Spain 23007
    288 Site Ref # / Investigator 49689 Lerida Spain 25198
    289 Site Ref # / Investigator 49686 Madrid Spain 28007
    290 Site Ref # / Investigator 49697 Madrid Spain 28034
    291 Site Ref # / Investigator 49679 Madrid Spain 28040
    292 Site Ref # / Investigator 49650 Madrid Spain 28041
    293 Site Ref # / Investigator 49683 Madrid Spain 28046
    294 Site Ref # / Investigator 49687 Madrid Spain 28222
    295 Site Ref # / Investigator 49692 Madrid Spain 28905
    296 Site Ref # / Investigator 49664 Madrid Spain 28911
    297 Site Ref # / Investigator 49696 Madrid Spain 28922
    298 Site Ref # / Investigator 49665 Malaga Spain 29010
    299 Site Ref # / Investigator 49691 Malaga Spain 29010
    300 Site Ref # / Investigator 49685 Mostoles-Madrid Spain 28935
    301 Site Ref # / Investigator 49666 Sant Joan Despi (Barcelona) Spain 08970
    302 Site Ref # / Investigator 49688 Seville Spain 41071
    303 Site Ref # / Investigator 49694 Toledo Spain 45004
    304 Site Ref # / Investigator 49654 Valencia Spain 46017
    305 Site Ref # / Investigator 49648 Vic (Barcelona) Spain 08500
    306 Site Ref # / Investigator 49485 Brighton United Kingdom BN2 5BE
    307 Site Ref # / Investigator 49470 Greater Manchester United Kingdom M6 8HD
    308 Site Ref # / Investigator 49471 Harrogate United Kingdom HG2 7SX
    309 Site Ref # / Investigator 49476 Manchester United Kingdom M41 5SL
    310 Site Ref # / Investigator 49486 Oxford United Kingdom OX3 7LD
    311 Site Ref # / Investigator 49472 Wigan United Kingdom WN6 9EP

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Laura Redden, MD, PhD, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott
    ClinicalTrials.gov Identifier:
    NCT00234884
    Other Study ID Numbers:
    • M03-634
    First Posted:
    Oct 10, 2005
    Last Update Posted:
    Sep 30, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by Abbott
    rheumatoid arthritis
    adalimumab
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Adalimumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Adalimumab
    Arm/Group Description Participants were treated with commercially available adalimumab in normal clinical practice.
    Period Title: Overall Study
    STARTED 3435
    COMPLETED 1805
    NOT COMPLETED 1630

    Baseline Characteristics

    Arm/Group Title Adalimumab
    Arm/Group Description Participants were treated with commercially available adalimumab in normal clinical practice.
    Overall Participants 3435
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.5
    (12.5)
    Sex: Female, Male (Count of Participants)
    Female
    2724
    79.3%
    Male
    711
    20.7%
    Region of Enrollment (participants) [Number]
    Portugal
    55
    1.6%
    France
    689
    20.1%
    Greece
    232
    6.8%
    Spain
    476
    13.9%
    Belgium
    318
    9.3%
    Australia
    20
    0.6%
    Austria
    95
    2.8%
    Netherlands
    248
    7.2%
    Germany
    561
    16.3%
    United Kingdom
    69
    2%
    Italy
    672
    19.6%

    Outcome Measures

    1. Primary Outcome
    Title Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)
    Description DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.
    Time Frame Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

    Outcome Measure Data

    Analysis Population Description
    Results are presented as observed. The number of participants evaluated is indicated for each time point below.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants were treated with commercially available adalimumab in normal clinical practice.
    Measure Participants 3435
    Baseline of NCT00448383 (Study M02-497) (N = 3407)
    6.0
    (1.1)
    Baseline of NCT00234884 (Study M03-634) (N = 2746)
    3.3
    (1.3)
    Month 12 (N = 2430)
    3.1
    (1.3)
    Month 24 (N = 2033)
    3.0
    (1.3)
    Month 36 (N = 1746)
    3.0
    (1.2)
    Month 48 (N = 1518)
    2.9
    (1.2)
    Month 60 (N = 1255)
    2.8
    (1.2)
    Last Observed Value (N = 3281)
    3.3
    (1.5)
    2. Primary Outcome
    Title American College of Rheumatology 20% (ACR20) Response Rate
    Description ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
    Time Frame Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

    Outcome Measure Data

    Analysis Population Description
    Results are presented as observed. The number of participants evaluated is indicated for each time point below.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants were treated with commercially available adalimumab in normal clinical practice.
    Measure Participants 3435
    Baseline of NCT00234884 (Study M03-634) (N = 2886)
    80.3
    2.3%
    Month 12 (N = 2508)
    82.9
    2.4%
    Month 24 (N = 2116)
    84.5
    2.5%
    Month 36 (N = 1811)
    84.8
    2.5%
    Month 48 (N = 1572)
    85.8
    2.5%
    Month 60 (N = 1309)
    87.9
    2.6%
    Last Observed Value (N = 3236)
    75.8
    2.2%
    3. Primary Outcome
    Title American College of Rheumatology 50% (ACR50) Response Rate
    Description ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
    Time Frame Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

    Outcome Measure Data

    Analysis Population Description
    Results are presented as observed. The number of participants evaluated is indicated for each time point below.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants were treated with commercially available adalimumab in normal clinical practice.
    Measure Participants 3435
    Baseline of NCT00234884 (Study M03-634) (N = 2873)
    58.8
    1.7%
    Month 12 (N = 2509)
    62.9
    1.8%
    Month 24 (N = 2109)
    66.6
    1.9%
    Month 36 (N = 1797)
    66.2
    1.9%
    Month 48 (N = 1564)
    68.3
    2%
    Month 60 (N = 1293)
    70.1
    2%
    Last Observed Value (N = 3238)
    55.8
    1.6%
    4. Primary Outcome
    Title American College of Rheumatology 70% (ACR70) Response Rate
    Description ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).
    Time Frame Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

    Outcome Measure Data

    Analysis Population Description
    Results are presented as observed. The number of participants evaluated is indicated for each time point below.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants were treated with commercially available adalimumab in normal clinical practice.
    Measure Participants 3435
    Baseline of NCT00234884 (Study M03-634) (N = 2889)
    34.9
    1%
    Month 12 (N = 2497)
    40.2
    1.2%
    Month 24 (N = 2106)
    42.9
    1.2%
    Month 36 (N = 1786)
    44.1
    1.3%
    Month 48 (N = 1554)
    47.0
    1.4%
    Month 60 (N = 1297)
    47.5
    1.4%
    Last Observed Value (N = 3240)
    37.0
    1.1%
    5. Primary Outcome
    Title Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)
    Description HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).
    Time Frame Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

    Outcome Measure Data

    Analysis Population Description
    Results are presented as observed. The number of participants evaluated is indicated for each time point below.
    Arm/Group Title Adalimumab
    Arm/Group Description Participants were treated with commercially available adalimumab in normal clinical practice.
    Measure Participants 3435
    Baseline of NCT00234884 (Study M03-634) (N = 2976)
    -0.70
    (0.65)
    Month 12 (N = 2590)
    -0.72
    (0.66)
    Month 24 (N = 2177)
    -0.74
    (0.68)
    Month 36 (N = 1863)
    -0.75
    (0.68)
    Month 48 (N = 1622)
    -0.76
    (0.70)
    Month 60 (N = 1348)
    -0.74
    (0.69)
    Last Observed value (N = 3322)
    -0.65
    (0.73)

    Adverse Events

    Time Frame Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
    Adverse Event Reporting Description
    Arm/Group Title Adalimumab
    Arm/Group Description Participants were treated with commercially available adalimumab in normal clinical practice.
    All Cause Mortality
    Adalimumab
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Adalimumab
    Affected / at Risk (%) # Events
    Total 755/3435 (22%)
    Blood and lymphatic system disorders
    Agranulocytosis 1/3435 (0%) 1
    Anaemia 5/3435 (0.1%) 5
    Haemorrhagic anaemia 1/3435 (0%) 1
    Hypereosinophilic syndrome 1/3435 (0%) 1
    Iron deficiency anaemia 2/3435 (0.1%) 2
    Leukopenia 2/3435 (0.1%) 2
    Lymphoadenopathy 2/3435 (0.1%) 2
    Lymphadenopathy mediastinal 2/3435 (0.1%) 2
    Microcytic anaemia 3/3435 (0.1%) 3
    Neutropenia 1/3435 (0%) 1
    Pancytopenia 2/3435 (0.1%) 2
    Splenic haemorrhage 1/3435 (0%) 1
    Thrombocytopenia 3/3435 (0.1%) 3
    Cardiac disorders
    Acute left ventricular failure 1/3435 (0%) 1
    Acute myocardial infarction 8/3435 (0.2%) 8
    Angina pectoris 12/3435 (0.3%) 12
    Angina unstable 2/3435 (0.1%) 2
    Aortic valve incompetence 1/3435 (0%) 2
    Aortic valve stenosis 1/3435 (0%) 1
    Arrhythmia 5/3435 (0.1%) 5
    Atrial fibrillation 17/3435 (0.5%) 20
    Atrial flutter 1/3435 (0%) 1
    Atrioventricular block 1/3435 (0%) 1
    Atrioventricular block complete 1/3435 (0%) 1
    Cardiac arrest 1/3435 (0%) 1
    Cardiac failure 9/3435 (0.3%) 11
    Cardiac failure acute 1/3435 (0%) 1
    Cardiac failure congestive 9/3435 (0.3%) 11
    Cardio-respiratory arrest 1/3435 (0%) 1
    Coronary artery disease 10/3435 (0.3%) 10
    Coronary artery stenosis 2/3435 (0.1%) 2
    Hypertensive heart disease 2/3435 (0.1%) 2
    Ischaemic cardiomyopathy 2/3435 (0.1%) 2
    Left ventricular dysfunction 1/3435 (0%) 1
    Left ventricular failure 1/3435 (0%) 1
    Mitral valve incompetence 1/3435 (0%) 1
    Myocardial infarction 25/3435 (0.7%) 25
    Myocardial ischaemia 6/3435 (0.2%) 6
    Pericardial effusion 5/3435 (0.1%) 5
    Stress cardiomyopathy 1/3435 (0%) 1
    Tachycardia paroxysmal 1/3435 (0%) 1
    Congenital, familial and genetic disorders
    Branchial cyst 1/3435 (0%) 1
    Gastrointestinal angiodysplasia haemorrhagic 1/3435 (0%) 1
    Odontogenic cyst 1/3435 (0%) 1
    Polydactyly 1/3435 (0%) 1
    Ear and labyrinth disorders
    Deafness neurosensory 1/3435 (0%) 1
    Hearing impaired 1/3435 (0%) 1
    Sudden hearing loss 1/3435 (0%) 2
    Vertigo 3/3435 (0.1%) 3
    Endocrine disorders
    Cushing's syndrome 1/3435 (0%) 1
    Goitre 3/3435 (0.1%) 3
    Hyperparathyroidism 1/3435 (0%) 1
    Toxic nodular goitre 3/3435 (0.1%) 3
    Eye disorders
    Cataract 3/3435 (0.1%) 3
    Entropion 1/3435 (0%) 1
    Macular degeneration 1/3435 (0%) 1
    Optic ischaemic neuropathy 1/3435 (0%) 1
    Retinal degeneration 1/3435 (0%) 1
    Retinal detachment 1/3435 (0%) 2
    Gastrointestinal disorders
    Abdominal discomfort 1/3435 (0%) 1
    Abdominal pain 1/3435 (0%) 1
    Abdominal pain upper 1/3435 (0%) 1
    Abdominal tenderness 1/3435 (0%) 1
    Anal fistula 2/3435 (0.1%) 2
    Anorectal stenosis 1/3435 (0%) 1
    Caecitis 1/3435 (0%) 1
    Colitis 2/3435 (0.1%) 2
    Colitis collagenous 1/3435 (0%) 1
    Colonic obstruction 1/3435 (0%) 1
    Constipation 1/3435 (0%) 1
    Crohn's disease 2/3435 (0.1%) 2
    Diarrhoea 8/3435 (0.2%) 8
    Diverticular perforation 1/3435 (0%) 1
    Diverticulum 1/3435 (0%) 1
    Duodenal fistula 1/3435 (0%) 1
    Duodenal ulcer 1/3435 (0%) 1
    Duodenitis 1/3435 (0%) 1
    Enterocolitis haemorrhagic 1/3435 (0%) 1
    Femoral hernia 1/3435 (0%) 1
    Gastric haemorrhage 1/3435 (0%) 1
    Gastric ulcer 1/3435 (0%) 1
    Gastritis 2/3435 (0.1%) 2
    Gastrointestinal haemorrhage 1/3435 (0%) 1
    Gastrooesophageal reflux disease 1/3435 (0%) 1
    Haemorrhoids 2/3435 (0.1%) 2
    Inguinal hernia 4/3435 (0.1%) 4
    Intestinal infarction 1/3435 (0%) 1
    Intestinal obstruction 1/3435 (0%) 1
    Intestinal perforation 1/3435 (0%) 1
    Large intestine perforation 1/3435 (0%) 1
    Pancreatitis 2/3435 (0.1%) 2
    Pancreatitis acute 4/3435 (0.1%) 4
    Peritonitis 1/3435 (0%) 1
    Polyp colorectal 1/3435 (0%) 1
    Rectal haemorrhage 1/3435 (0%) 1
    Rectal prolapse 1/3435 (0%) 1
    Reflux oesophagitis 2/3435 (0.1%) 2
    Retroperitoneal haematoma 1/3435 (0%) 1
    Umbilical hernia 4/3435 (0.1%) 4
    Upper gastrointestinal haemorrhage 1/3435 (0%) 1
    Vasculitis gastrointestinal 1/3435 (0%) 1
    Vomiting 2/3435 (0.1%) 2
    General disorders
    Chest pain 8/3435 (0.2%) 8
    Death 3/3435 (0.1%) 3
    Device dislocation 5/3435 (0.1%) 5
    Device occlusion 1/3435 (0%) 1
    Impaired healing 1/3435 (0%) 1
    Multi-organ failure 4/3435 (0.1%) 4
    Pyrexia 9/3435 (0.3%) 9
    Soft tissue inflammation 1/3435 (0%) 1
    Sudden death 2/3435 (0.1%) 2
    Hepatobiliary disorders
    Autoimmune hepatitis 1/3435 (0%) 1
    Biliary cirrhosis primary 1/3435 (0%) 1
    Cholecystitis 7/3435 (0.2%) 7
    Cholecystitis acute 3/3435 (0.1%) 3
    Cholelithiasis 18/3435 (0.5%) 20
    Hepatic failure 2/3435 (0.1%) 2
    Hepatotoxicity 1/3435 (0%) 1
    Immune system disorders
    Amyloidosis 2/3435 (0.1%) 2
    Drug hypersensitivity 1/3435 (0%) 1
    Hypersensitivity 1/3435 (0%) 1
    Sarcoidosis 1/3435 (0%) 1
    Secondary amyloidosis 1/3435 (0%) 1
    Infections and infestations
    Abdominal abscess 1/3435 (0%) 1
    Abdominal wall abscess 1/3435 (0%) 1
    Abscess 2/3435 (0.1%) 2
    Abscess neck 1/3435 (0%) 1
    Anal abscess 2/3435 (0.1%) 3
    Appendicitis 3/3435 (0.1%) 3
    Arthritis bacterial 11/3435 (0.3%) 12
    Atypical mycobacterial infection 1/3435 (0%) 1
    Bacteraemia 1/3435 (0%) 1
    Bacterial pyelonephritis 1/3435 (0%) 1
    Bronchitis 6/3435 (0.2%) 6
    Bronchopneumonia 4/3435 (0.1%) 4
    Bursitis infective 3/3435 (0.1%) 3
    Cellulitis 7/3435 (0.2%) 7
    Chronic sinusitis 2/3435 (0.1%) 2
    Cystitis 1/3435 (0%) 1
    Cytomegalovirus infection 1/3435 (0%) 1
    Device related infection 1/3435 (0%) 1
    Diverticulitis 5/3435 (0.1%) 5
    Endocarditis staphylococcal 1/3435 (0%) 1
    Enterocolitis infectious 1/3435 (0%) 1
    Epstein-Barr virus infection 1/3435 (0%) 1
    Extrapulmonary tuberculosis 1/3435 (0%) 1
    Gangrene 2/3435 (0.1%) 2
    Gastroenteritis 6/3435 (0.2%) 6
    Gastroenteritis viral 1/3435 (0%) 1
    H1N1 influenza 1/3435 (0%) 1
    Haematoma infection 1/3435 (0%) 1
    Helicobacter gastritis 1/3435 (0%) 1
    Hepatic echinococciasis 1/3435 (0%) 1
    Herpes zoster 5/3435 (0.1%) 5
    Histoplasmosis 1/3435 (0%) 3
    Infected skin ulcer 1/3435 (0%) 2
    Influenza 2/3435 (0.1%) 2
    Joint tuberculosis 1/3435 (0%) 1
    Leishmaniasis 1/3435 (0%) 1
    Listeria sepsis 1/3435 (0%) 1
    Lobar pneumonia 4/3435 (0.1%) 4
    Localised infection 3/3435 (0.1%) 3
    Lower respiratory tract infection 3/3435 (0.1%) 3
    Lung abscess 1/3435 (0%) 1
    Lung infections 9/3435 (0.3%) 10
    Lyme disease 1/3435 (0%) 1
    Lymphadenitis bacterial 1/3435 (0%) 1
    Meningitis meningococcal 1/3435 (0%) 1
    Mucocutaneous leishmaniasis 1/3435 (0%) 1
    Mycobacterium avium complex infection 2/3435 (0.1%) 2
    Mycobacterium fortuitum infection 1/3435 (0%) 1
    Necrotising fasciitis 1/3435 (0%) 1
    Oseophageal candidiasis 1/3435 (0%) 1
    Orchitis 1/3435 (0%) 1
    Osteomyelitis 3/3435 (0.1%) 4
    Parainfluenzae virus infection 1/3435 (0%) 1
    Peritoneal infection 1/3435 (0%) 1
    Peritoneal tuberculosis 1/3435 (0%) 1
    Peritonsillar abscess 1/3435 (0%) 1
    Pharyngitis 1/3435 (0%) 1
    Pleurisy viral 1/3435 (0%) 1
    Pneumococcal sepsis 2/3435 (0.1%) 2
    Pneumonia 42/3435 (1.2%) 44
    Pneumonia legionella 1/3435 (0%) 1
    Pneumonia primary atypical 1/3435 (0%) 1
    Postoperative wound infection 3/3435 (0.1%) 3
    Pseudomembranous colitis 1/3435 (0%) 1
    Pulmonary tuberculosis 3/3435 (0.1%) 3
    Pyelonephritis 2/3435 (0.1%) 2
    Pyelonephritis acute 4/3435 (0.1%) 4
    Pyothorax 1/3435 (0%) 1
    Respiratory tract infection 7/3435 (0.2%) 8
    Salmonellosis 1/3435 (0%) 1
    Sepsis 10/3435 (0.3%) 10
    Septic arthritis staphylococcal 1/3435 (0%) 1
    Septic shock 3/3435 (0.1%) 3
    Sinusitis 2/3435 (0.1%) 2
    Skin infection 1/3435 (0%) 1
    Staphylococcal bacteraemia 1/3435 (0%) 1
    Staphylococcal osteomyelitis 1/3435 (0%) 1
    Staphylococcal sepsis 1/3435 (0%) 1
    Subcutaneous abscess 1/3435 (0%) 1
    Tonsillitis 1/3435 (0%) 1
    Tooth infection 1/3435 (0%) 1
    Tracheobronchitis 1/3435 (0%) 1
    Tuberculosis 3/3435 (0.1%) 3
    Upper respiratory tract infection 1/3435 (0%) 1
    Urinary tract infection 11/3435 (0.3%) 11
    Urosepsis 3/3435 (0.1%) 3
    Vaginal abscess 1/3435 (0%) 1
    Varicella 1/3435 (0%) 1
    Viral infection 1/3435 (0%) 1
    Viral pericarditis 2/3435 (0.1%) 2
    Viral upper respiratory tract infection 1/3435 (0%) 1
    Visceral leishmaniasis 1/3435 (0%) 1
    Wound infection 6/3435 (0.2%) 6
    Disseminated tuberculosis 2/3435 (0.1%) 2
    Erysipelas 13/3435 (0.4%) 15
    Escherichia sepsis 2/3435 (0.1%) 2
    Injury, poisoning and procedural complications
    Anaemia postoperative 1/3435 (0%) 1
    Ankle fracture 5/3435 (0.1%) 5
    Arterial injury 1/3435 (0%) 1
    Concussion 2/3435 (0.1%) 2
    Decompression sickness 1/3435 (0%) 1
    Diffuse axonal injury 1/3435 (0%) 1
    Fall 9/3435 (0.3%) 9
    Femoral neck fracture 6/3435 (0.2%) 6
    Femur fracture 7/3435 (0.2%) 7
    Fibula fracture 3/3435 (0.1%) 3
    Foot fracture 4/3435 (0.1%) 4
    Foreign body 1/3435 (0%) 1
    Fractured ischium 1/3435 (0%) 1
    Fractured sacrum 2/3435 (0.1%) 2
    Graft thrombosis 1/3435 (0%) 1
    Heat stroke 1/3435 (0%) 1
    Hip fracture 9/3435 (0.3%) 9
    Humerus fracture 6/3435 (0.2%) 7
    In-stent coronary artery restenosis 1/3435 (0%) 1
    Joint dislocation 1/3435 (0%) 1
    Ligament injury 1/3435 (0%) 1
    Ligament rupture 1/3435 (0%) 1
    Limb injury 1/3435 (0%) 1
    Lower limb fracture 1/3435 (0%) 1
    Lumbar vertebral fracture 4/3435 (0.1%) 4
    Meniscus lesion 2/3435 (0.1%) 2
    Multiple fractures 1/3435 (0%) 1
    Overdose 2/3435 (0.1%) 2
    Patella fracture 1/3435 (0%) 1
    Pelvic fracture 2/3435 (0.1%) 2
    Periprosthetic fracture 1/3435 (0%) 1
    Post procedural haemorrhage 1/3435 (0%) 1
    Procedural pain 1/3435 (0%) 1
    Pubis fracture 1/3435 (0%) 1
    Radius fracture 3/3435 (0.1%) 3
    Rib fracture 2/3435 (0.1%) 2
    Road traffic accident 3/3435 (0.1%) 3
    Seroma 1/3435 (0%) 1
    Spinal fracture 2/3435 (0.1%) 2
    Splenic injury 1/3435 (0%) 1
    Splenic rupture 1/3435 (0%) 1
    Sternal fracture 1/3435 (0%) 1
    Subcutaneous haematoma 1/3435 (0%) 1
    Tendon rupture 2/3435 (0.1%) 2
    Therapeutic agent toxicity 2/3435 (0.1%) 2
    Thoracic vertebral fracture 1/3435 (0%) 1
    Tibia fracture 6/3435 (0.2%) 6
    Traumatic brain injury 1/3435 (0%) 1
    Traumatic haematoma 1/3435 (0%) 1
    Ulna fracture 3/3435 (0.1%) 3
    Upper limb fracture 4/3435 (0.1%) 4
    Vascular pseudoaneurysm 1/3435 (0%) 1
    Wound 1/3435 (0%) 1
    Wrist fracture 1/3435 (0%) 1
    Investigations
    Antiphospholipid antibodies 1/3435 (0%) 1
    Blood alkaline phosphatase increased 1/3435 (0%) 1
    Blood amylase increased 1/3435 (0%) 1
    Blood creatine phosphokinase increased 1/3435 (0%) 1
    C-reactive protein increased 1/3435 (0%) 1
    Gamma-glutamyltransferase increased 2/3435 (0.1%) 2
    Mycobacterium test positive 1/3435 (0%) 1
    Platelet count decreased 1/3435 (0%) 1
    Red blood cell sedimentation rate increased 1/3435 (0%) 1
    Weight decreased 1/3435 (0%) 1
    Metabolism and nutrition disorders
    Central obesity 1/3435 (0%) 1
    Decreased appetite 1/3435 (0%) 1
    Dehydration 2/3435 (0.1%) 2
    Diabetes mellitus 1/3435 (0%) 1
    Diabetes mellitus inadequate control 1/3435 (0%) 1
    Diabetic ketoacidosis 1/3435 (0%) 1
    Gout 1/3435 (0%) 1
    Hypercalcaemia 1/3435 (0%) 1
    Hypoglycaemia 1/3435 (0%) 1
    Hypoglycaemic seizure 1/3435 (0%) 1
    Hypokalaemia 1/3435 (0%) 1
    Ketoacidosis 1/3435 (0%) 1
    Obesity 1/3435 (0%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/3435 (0.1%) 3
    Arthritis 3/3435 (0.1%) 3
    Atlantoaxial instability 1/3435 (0%) 1
    Back pain 2/3435 (0.1%) 3
    Bone formation decreased 1/3435 (0%) 1
    Felty's syndrome 1/3435 (0%) 1
    Fibromyalgia 1/3435 (0%) 1
    Fistula 1/3435 (0%) 1
    Foot deformity 8/3435 (0.2%) 8
    Fracture nonunion 2/3435 (0.1%) 2
    Intervertebral disc disorder 1/3435 (0%) 1
    Intervertebral disc protrusion 5/3435 (0.1%) 5
    Intervertebral disc space narrowing 1/3435 (0%) 1
    Joint destruction 4/3435 (0.1%) 4
    Joint effusion 1/3435 (0%) 1
    Joint range of motion decreased 1/3435 (0%) 1
    Lumbar spinal stenosis 3/3435 (0.1%) 3
    Lupus-like syndrome 1/3435 (0%) 1
    Osteitis 2/3435 (0.1%) 2
    Osteoarthritis 18/3435 (0.5%) 19
    Osteonecrosis 4/3435 (0.1%) 4
    Osteoporotic fracture 1/3435 (0%) 1
    Pathological fracture 2/3435 (0.1%) 2
    Periostitis 1/3435 (0%) 1
    Pseudarthritis 1/3435 (0%) 1
    Rheumatoid arthritis 7/3435 (0.2%) 7
    Spinal column stenosis 3/3435 (0.1%) 3
    Spinal osteoarthritis 3/3435 (0.1%) 6
    Spondylolisthesis 2/3435 (0.1%) 2
    Systemic lupus erythematosus 3/3435 (0.1%) 3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma pancreas 1/3435 (0%) 1
    B-cell lymphoma 3/3435 (0.1%) 3
    B-cell lymphoma stage I 1/3435 (0%) 1
    Basal cell carcinoma 6/3435 (0.2%) 6
    Benign breast neoplasm 2/3435 (0.1%) 2
    Benign lung neoplasm 1/3435 (0%) 1
    Bile duct cancer 1/2 (50%) 1
    Bladder cancer 2/3435 (0.1%) 2
    Bladder neoplasm 1/3435 (0%) 1
    Bladder papilloma 1/3435 (0%) 1
    Breast cancer 15/3435 (0.4%) 15
    Breast cancer metastatic 1/3435 (0%) 1
    Breast cancer stage I 1/3435 (0%) 1
    Breast cancer stage II 1/3435 (0%) 1
    Bronchial carcinoma 1/3435 (0%) 1
    Cerebellopontine angle tumour 1/3435 (0%) 1
    Chronic lymphocytic leukaemia 3/3435 (0.1%) 3
    Colon cancer 6/3435 (0.2%) 6
    Colon cancer stage II 1/3435 (0%) 1
    Colorectal cancer 1/3435 (0%) 1
    Conjunctival melanoma 1/3435 (0%) 1
    Desmoid tumour 1/3435 (0%) 1
    Diffuse large B-cell lymphoma 1/3435 (0%) 1
    Endometrial cancer 2/3435 (0.1%) 2
    Fibroadenoma of breast 1/3435 (0%) 1
    Glioblastoma multiforme 1/3435 (0%) 1
    Glomus jugulare tumour 1/3435 (0%) 1
    Hodgkin's disease 1/3435 (0%) 1
    Hodgkin's disease stage II 1/3435 (0%) 1
    Hodgkin's disease stage III 1/3435 (0%) 1
    Intraductal papilloma of breast 1/3435 (0%) 1
    Lung adenocarcinoma 3/3435 (0.1%) 3
    Lung neoplasm 2/3435 (0.1%) 2
    Lung neoplasm malignant 2/3435 (0.1%) 2
    Lymphoma 1/3435 (0%) 1
    Lymphoproliferative disorder 1/3435 (0%) 1
    Malignant melanoma 3/3435 (0.1%) 3
    Malignant melanoma in situ 1/3435 (0%) 1
    Meningioma 1/3435 (0%) 1
    Metastases to lung 1/3435 (0%) 1
    Metastatic neoplasm 1/3435 (0%) 1
    Metastatic renal cell carcinoma 1/3435 (0%) 1
    Metastatic squamous cell carcinoma 1/3435 (0%) 1
    Multiple myeloma 1/3435 (0%) 1
    Myelodysplastic syndrome 1/3435 (0%) 1
    Myeloproliferative disorder 1/3435 (0%) 1
    Non-Hodgkin's lymphoma 1/3435 (0%) 1
    Ovarian adenoma 1/3435 (0%) 1
    Ovarian cancer 2/3435 (0.1%) 2
    Ovarian fibroma 1/3435 (0%) 1
    Ovarian granulosa-theca cell tumour 1/3435 (0%) 1
    Pancreatic carcinoma 3/3435 (0.1%) 3
    Phaeochromocytoma 1/3435 (0%) 1
    Plasmacytoma 2/3435 (0.1%) 2
    Primary mediastinal large B-cell lymphoma 1/3435 (0%) 1
    Prostate cancer 6/3435 (0.2%) 6
    Prostate cancer metastatic 1/3435 (0%) 1
    Prostate cancer recurrent 1/3435 (0%) 1
    Prostate cancer stage 0 1/3435 (0%) 1
    Prostate cancer stage I 1/3435 (0%) 1
    Prostatic adenoma 1/3435 (0%) 1
    Rectal cancer 2/3435 (0.1%) 2
    Renal cell carcinoma 1/3435 (0%) 1
    Small cell lung cancer metastatic 1/3435 (0%) 1
    Squamous cell carcinoma 3/3435 (0.1%) 3
    Thyroid neoplasm 3/3435 (0.1%) 3
    Uterine cancer 1/3435 (0%) 1
    Uterine leiomyoma 10/3435 (0.3%) 10
    Nervous system disorders
    Amnestic disorder 1/3435 (0%) 1
    Amyotrophic lateral sclerosis 3/3435 (0.1%) 3
    Carotid artery stenosis 1/3435 (0%) 1
    Carpal tunnel syndrome 2/3435 (0.1%) 2
    Cerebellar atrophy 1/3435 (0%) 1
    Cerebral arteriosclerosis 1/3435 (0%) 1
    Cerebral haematoma 1/3435 (0%) 1
    Cerebral haemorrhage 1/3435 (0%) 1
    Cerebral infarction 4/3435 (0.1%) 4
    Cerebral ischaemia 1/3435 (0%) 1
    Cerebral venous thrombosis 1/3435 (0%) 1
    Cerebrovascular accident 11/3435 (0.3%) 11
    Cervical myelopathy 1/3435 (0%) 1
    Cervicobrachial syndrome 1/3435 (0%) 1
    Coma 1/3435 (0%) 1
    Dementia Alzheimer's type 2/3435 (0.1%) 2
    Dizziness 2/3435 (0.1%) 2
    Dysaesthesia 1/3435 (0%) 1
    Encephalitis 1/3435 (0%) 1
    Epilepsy 1/3435 (0%) 1
    Facial palsy 2/3435 (0.1%) 2
    Haemorrhagic stroke 2/3435 (0.1%) 2
    Headache 2/3435 (0.1%) 2
    Hypoglycaemic coma 1/3435 (0%) 1
    Hypoxic encephalopathy 1/3435 (0%) 1
    Ischaemic stroke 5/3435 (0.1%) 5
    Loss off consciousness 2/3435 (0.1%) 2
    Mononeuropathy multiplex 1/3435 (0%) 1
    Optic neuritis 2/3435 (0.1%) 2
    Parkinson's disease 1/3435 (0%) 1
    Partial seizures 1/3435 (0%) 1
    Sciatica 4/3435 (0.1%) 4
    Speech disorder 1/3435 (0%) 1
    Transient global amnesia 1/3435 (0%) 1
    Transient ischaemic attack 6/3435 (0.2%) 6
    Vascular dementia 1/3435 (0%) 1
    Vascular encephalopathy 1/3435 (0%) 1
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 3/3435 (0.1%) 3
    Intra-uterine death 1/3435 (0%) 1
    Placenta previa 1/3435 (0%) 1
    Psychiatric disorders
    Abnormal behaviour 1/3435 (0%) 1
    Anxiety 1/3435 (0%) 1
    Depression 2/3435 (0.1%) 2
    Disorientation 1/3435 (0%) 1
    Suicide attempt 4/3435 (0.1%) 5
    Renal and urinary disorders
    Calculus bladder 1/3435 (0%) 1
    Calculus ureteric 5/3435 (0.1%) 6
    Calculus urinary 1/3435 (0%) 1
    Glomerulonephritis 1/3435 (0%) 1
    Hydronephrosis 2/3435 (0.1%) 2
    Nephrolithiasis 3/3435 (0.1%) 3
    Nephrotic syndrome 1/3435 (0%) 1
    Renal artery stenosis 1/3435 (0%) 1
    Renal colic 3/3435 (0.1%) 3
    Renal failure 7/3435 (0.2%) 7
    Renal failure acute 7/3435 (0.2%) 7
    Ureteric rupture 1/3435 (0%) 1
    Ureteric stenosis 1/3435 (0%) 2
    Reproductive system and breast disorders
    Adnexa uteri cyst 1/3435 (0%) 1
    Benign prostatic hyperplasia 2/3435 (0.1%) 2
    Breast cyst 1/3435 (0%) 1
    Breast enlargement 2/3435 (0.1%) 2
    Cervical dysplasia 2/3435 (0.1%) 2
    Cystocele 3/3435 (0.1%) 3
    Genital prolapse 1/3435 (0%) 1
    Ovarian cyst 1/3435 (0%) 1
    Pelvic fluid collection 1/3435 (0%) 1
    Prostatic disorder 1/3435 (0%) 1
    Prostatitis 3/3435 (0.1%) 3
    Rectocele 2/3435 (0.1%) 2
    Uterine polyp 1/3435 (0%) 1
    Uterine prolapse 5/3435 (0.1%) 5
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 5/3435 (0.1%) 5
    Anoxia 1/3435 (0%) 1
    Asthma 2/3435 (0.1%) 2
    Bronchial hyperreactivity 1/3435 (0%) 1
    Bronchitis chronic 1/3435 (0%) 1
    Chronic obstructive pulmonary disease 6/3435 (0.2%) 7
    Cough 2/3435 (0.1%) 2
    Diaphragmatic hernia 3/3435 (0.1%) 3
    Dyspnoea 3/3435 (0.1%) 3
    Emphysema 1/3435 (0%) 1
    Epistaxis 1/3435 (0%) 1
    Interstitial lung disease 2/3435 (0.1%) 2
    Laryngeal oedema 1/3435 (0%) 1
    Lung disorder 1/3435 (0%) 1
    Nasal septum deviation 2/3435 (0.1%) 2
    Nasal tubinate hypertrophy 1/3435 (0%) 1
    Organising pneumonia 1/3435 (0%) 1
    Pleural disorder 1/3435 (0%) 1
    Pleural effusion 11/3435 (0.3%) 11
    Pleurisy 5/3435 (0.1%) 5
    Pneumonia aspiration 3/3435 (0.1%) 3
    Pneumothorax 1/3435 (0%) 1
    Pulmonary embolism 9/3435 (0.3%) 10
    Pulmonary fibrosis 3/3435 (0.1%) 4
    Pulmonary granuloma 1/3435 (0%) 1
    Pulmonary hypertension 1/3435 (0%) 1
    Pulmonary mass 1/3435 (0%) 1
    Pulmonary oedema 1/3435 (0%) 1
    Respiratory failure 4/3435 (0.1%) 4
    Restrictive pulmonary disease 1/3435 (0%) 1
    Rheumatoid lung 2/3435 (0.1%) 2
    Sinus polyp 1/3435 (0%) 1
    Upper airway obstruction 1/3435 (0%) 1
    Vocal cord polyp 1/3435 (0%) 1
    Skin and subcutaneous tissue disorders
    Acne 1/3435 (0%) 1
    Acute febrile neutrophilic dermatosis 1/3435 (0%) 1
    Alopecia effluvium 1/3435 (0%) 1
    Cutaneous lupus erythematosis 2/3435 (0.1%) 2
    Cutaneous vasculitis 1/3435 (0%) 1
    Eczema 1/3435 (0%) 1
    Erythema multiforme 1/3435 (0%) 1
    Hidradenitis 1/3435 (0%) 1
    Leukocytoclastic vasculitis 3/3435 (0.1%) 3
    Psoriasis 1/3435 (0%) 1
    Scar 1/3435 (0%) 1
    Skin necrosis 3/3435 (0.1%) 3
    Skin ulcer 5/3435 (0.1%) 6
    Urticaria 1/3435 (0%) 1
    Surgical and medical procedures
    Abortion induced 1/3435 (0%) 1
    Blepharoplasty 1/3435 (0%) 1
    Removal of internal fixation 1/3435 (0%) 1
    Vascular disorders
    Aortic aneurysm 2/3435 (0.1%) 2
    Aortic stenosis 2/3435 (0.1%) 2
    Arterial haemorrhage 2/3435 (0.1%) 2
    Arterial thrombosis limb 1/3435 (0%) 1
    Arteritis 1/3435 (0%) 1
    Deep vein thrombosis 5/3435 (0.1%) 5
    Haematoma 1/3435 (0%) 1
    Haemodynamic instability 2/3435 (0.1%) 2
    Hypertension 2/3435 (0.1%) 2
    Hypertensive crisis 3/3435 (0.1%) 4
    Hypotension 1/3435 (0%) 1
    Hypovolaemic shock 2/3435 (0.1%) 2
    Lymphoedema 1/3435 (0%) 1
    Peripheral arterial occlusive disease 3/3435 (0.1%) 3
    Phlebitis 1/3435 (0%) 1
    Raynaud's phenomenon 1/3435 (0%) 1
    Shock haemorrhagic 1/3435 (0%) 1
    Subclavian vein thrombosis 1/3435 (0%) 1
    Thrombophlebitis 1/3435 (0%) 1
    Thrombosis 4/3435 (0.1%) 4
    Varicose vein 1/3435 (0%) 1
    Vasculitis 2/3435 (0.1%) 2
    Venous insufficiency 1/3435 (0%) 1
    Venous thrombosis limb 1/3435 (0%) 1
    Other (Not Including Serious) Adverse Events
    Adalimumab
    Affected / at Risk (%) # Events
    Total 562/3435 (16.4%)
    Infections and infestations
    Bronchitis 244/3435 (7.1%)
    Nasopharyngitis 189/3435 (5.5%)
    Urinary tract infection 195/3435 (5.7%)

    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 1-800-633-9110
    Email
    Responsible Party:
    Abbott
    ClinicalTrials.gov Identifier:
    NCT00234884
    Other Study ID Numbers:
    • M03-634
    First Posted:
    Oct 10, 2005
    Last Update Posted:
    Sep 30, 2011
    Last Verified:
    Aug 1, 2011