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Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01077258
Collaborator
(none)
4,208
Enrollment
303
Locations
106.1
Duration (Months)
13.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over 2 years.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with rheumatoid arthritis who started treatment with adalimumab in a normal clinical setting according to the product label were documented. The follow-up observation period was for 2 years and focused on safety information and maintenance of efficacy during a normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4208 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Effectiveness and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice
    Study Start Date :
    Apr 1, 2004
    Actual Primary Completion Date :
    Feb 1, 2013
    Actual Study Completion Date :
    Feb 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Rheumatoid arthritis

    Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Disease Activity Score (DAS) 28 [Baseline and Months 3, 6, 9, 12, 18, and 24]

      The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

    2. Percentage of Participants in DAS28 Remission [Months 3, 6, 9, 12, 18, and 24]

      Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

    Secondary Outcome Measures

    1. Percentage of Participants With a Significant Therapeutic Response [Baseline and Months 3, 6, 9, 12, 18, and 24]

      Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

    2. Percentage of Participants With Low, Moderate and High Disease Activity [Baseline and Months 3, 6, 9, 12, 18, and 24]

      The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.

    3. Erythrocyte Sedimentation Rate (ESR) Over Time [Baseline and Months 3, 6, 9, 12, 18, and 24]

      Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.

    4. C-Reactive Protein (CRP) Levels Over Time [Baseline and Months 3, 6, 9, 12, 18, and 24]

      C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.

    5. Tender Joint Count (TJC) Over Time [Baseline and Months 3, 6, 9, 12, 18, and 24]

      Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

    6. Swollen Joint Count (SJC) Over Time [Baseline and Months 3, 6, 9, 12, 18, and 24]

      Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

    7. Hannover Functional Questionnaire (FFbH) Over Time [Baseline and Months 3, 6, 9, 12, 18, and 24]

      A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity.

    8. Patients Global Assessment of Disease Activity Over Time [Baseline and Months 3, 6, 9, 12, 18 and 24]

      Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

    9. Participants Assessment of Fatigue Over Time [Baseline and Month 3, 6, 9, 12, 18, and 24]

      Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

    10. Participants Assessment of Pain Over Time [Baseline and Months 3, 6, 9, 12, 18, and 24]

      Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.

    11. Percentage of Participants With Impairment in Daily Activities [Baseline and Months 3, 6, 9, 18, and 24]

      Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.

    12. Number of Days Missed From Work Due to Rheumatoid Arthritis [Baseline and Months 6, 12, 18, and 24]

      Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.

    13. Percentage of Participants With In-patient Hospitalization [Month 6, 12, 18, and 24]

      The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.

    14. Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication [Baseline and Months 3, 6, 9, 12, 18, and 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate

    • Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before. In case of incompatibility with methotrexate, Humira can be used as monotherapy

    Exclusion Criteria:

    • Hypersensitivity against the drug or one of the other ingredients

    • Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)

    • Moderate to severe cardiac insufficiency

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 35036 Aachen Germany 52062
    2 Site Reference ID/Investigator# 35510 Ahlen Germany 59227
    3 Site Reference ID/Investigator# 35040 Ahrensburg Germany 22926
    4 Site Reference ID/Investigator# 35043 Altenburg Germany 04600
    5 Site Reference ID/Investigator# 35046 Altenholz Germany 24161
    6 Site Reference ID/Investigator# 35049 Amberg Germany 92224
    7 Site Reference ID/Investigator# 35057 Arnstadt Germany 99310
    8 Site Reference ID/Investigator# 35520 Attendorn Germany 57439
    9 Site Reference ID/Investigator# 33349 Augsburg Germany 86150
    10 Site Reference ID/Investigator# 33358 Bad Abbach Germany 93077
    11 Site Reference ID/Investigator# 33361 Bad Abbach Germany 93077
    12 Site Reference ID/Investigator# 35142 Bad Aibling Germany 83043
    13 Site Reference ID/Investigator# 35570 Bad Brambach Germany 8648
    14 Site Reference ID/Investigator# 35573 Bad Bramstedt Germany 24576
    15 Site Reference ID/Investigator# 33372 Bad Endbach Germany 35080
    16 Site Reference ID/Investigator# 33378 Bad Iburg Germany 49186
    17 Site Reference ID/Investigator# 33382 Bad Iburg Germany 49186
    18 Site Reference ID/Investigator# 33387 Bad Kreuznach Germany 55543
    19 Site Reference ID/Investigator# 35575 Bad Kreuznach Germany 55543
    20 Site Reference ID/Investigator# 33391 Bad Liebenwerda Germany 04924
    21 Site Reference ID/Investigator# 33396 Bad Muender Germany 31848
    22 Site Reference ID/Investigator# 102216 Bad Nauheim Germany 61231
    23 Site Reference ID/Investigator# 35578 Bad Neuenahr Germany 53474
    24 Site Reference ID/Investigator# 33404 Bad Rappenau Germany 74906
    25 Site Reference ID/Investigator# 51883 Bad Salzungen Germany 36433
    26 Site Reference ID/Investigator# 33412 Bad Soden-Salmuenster Germany 63628
    27 Site Reference ID/Investigator# 33425 Baden-Baden Germany 76530
    28 Site Reference ID/Investigator# 33429 Bamberg Germany 96047
    29 Site Reference ID/Investigator# 33438 Bautzen Germany 02625
    30 Site Reference ID/Investigator# 33442 Bayreuth Germany 95445
    31 Site Reference ID/Investigator# 33446 Bayreuth Germany 95445
    32 Site Reference ID/Investigator# 34266 Berlin-Buch Germany 13125
    33 Site Reference ID/Investigator# 34252 Berlin-Wannsee Germany 14109
    34 Site Reference ID/Investigator# 33641 Berlin Germany 10117
    35 Site Reference ID/Investigator# 35089 Berlin Germany 10117
    36 Site Reference ID/Investigator# 33648 Berlin Germany 10178
    37 Site Reference ID/Investigator# 33693 Berlin Germany 10247
    38 Site Reference ID/Investigator# 33670 Berlin Germany 10369
    39 Site Reference ID/Investigator# 33658 Berlin Germany 10435
    40 Site Reference ID/Investigator# 33697 Berlin Germany 10711
    41 Site Reference ID/Investigator# 34246 Berlin Germany 10719
    42 Site Reference ID/Investigator# 33683 Berlin Germany 10777
    43 Site Reference ID/Investigator# 34269 Berlin Germany 10961
    44 Site Reference ID/Investigator# 35527 Berlin Germany 12161
    45 Site Reference ID/Investigator# 35597 Berlin Germany 12161
    46 Site Reference ID/Investigator# 33620 Berlin Germany 12207
    47 Site Reference ID/Investigator# 33690 Berlin Germany 12435
    48 Site Reference ID/Investigator# 33704 Berlin Germany 12435
    49 Site Reference ID/Investigator# 33687 Berlin Germany 13055
    50 Site Reference ID/Investigator# 33661 Berlin Germany 13437
    51 Site Reference ID/Investigator# 35550 Berlin Germany 13595
    52 Site Reference ID/Investigator# 33674 Berlin Germany 14109
    53 Site Reference ID/Investigator# 35551 Berlin Germany 14163
    54 Site Reference ID/Investigator# 34238 Berlin Germany 14199
    55 Site Reference ID/Investigator# 35556 Bernau Germany 16321
    56 Site Reference ID/Investigator# 34277 Biberach Germany 88400
    57 Site Reference ID/Investigator# 35562 Binzen Germany 79589
    58 Site Reference ID/Investigator# 34285 Blankenburg/Hart Germany 38889
    59 Site Reference ID/Investigator# 34288 Blaubeuren Germany 89143
    60 Site Reference ID/Investigator# 34291 Bocholt Germany 46399
    61 Site Reference ID/Investigator# 35566 Bocholt Germany 46399
    62 Site Reference ID/Investigator# 35641 Bochum Germany 44789
    63 Site Reference ID/Investigator# 35644 Bogen Germany 94327
    64 Site Reference ID/Investigator# 34302 Bonn Germany 53111
    65 Site Reference ID/Investigator# 35646 Bonn Germany 53129
    66 Site Reference ID/Investigator# 34296 Bonn Germany 53177
    67 Site Reference ID/Investigator# 35652 Bottrop Germany 46242
    68 Site Reference ID/Investigator# 34307 Braunschweig Germany 38100
    69 Site Reference ID/Investigator# 35603 Breitenbrunn Germany 08359
    70 Site Reference ID/Investigator# 35609 Bremen Germany 28209
    71 Site Reference ID/Investigator# 35611 Celle Germany 29223
    72 Site Reference ID/Investigator# 34699 Chemnitz Germany 09126
    73 Site Reference ID/Investigator# 35093 Chemnitz Germany D-09130
    74 Site Reference ID/Investigator# 35615 Coesfeld Germany 48653
    75 Site Reference ID/Investigator# 33989 Cologne Germany 50823
    76 Site Reference ID/Investigator# 35237 Cologne Germany 51067
    77 Site Reference ID/Investigator# 34708 Cottbus Germany 03042
    78 Site Reference ID/Investigator# 34711 Cottbus Germany 03046
    79 Site Reference ID/Investigator# 35621 Darmstadt Germany 64295
    80 Site Reference ID/Investigator# 34725 Deggendorf Germany 94469
    81 Site Reference ID/Investigator# 35631 Dessau-Rosslau Germany 6842
    82 Site Reference ID/Investigator# 34742 Dortmund Germany 44147
    83 Site Reference ID/Investigator# 35635 Dortmund Germany 44147
    84 Site Reference ID/Investigator# 35634 Dortmund Germany 44263
    85 Site Reference ID/Investigator# 35170 Dresden Germany 01097
    86 Site Reference ID/Investigator# 34754 Dresden Germany 01109
    87 Site Reference ID/Investigator# 34748 Dresden Germany 01277
    88 Site Reference ID/Investigator# 34751 Dresden Germany 01277
    89 Site Reference ID/Investigator# 34760 Dresden Germany 01277
    90 Site Reference ID/Investigator# 34773 Duesseldorf Germany 40211
    91 Site Reference ID/Investigator# 34768 Duesseldorf Germany 40217
    92 Site Reference ID/Investigator# 34778 Duisburg Germany 47055
    93 Site Reference ID/Investigator# 34784 Eberswalde Germany 16225
    94 Site Reference ID/Investigator# 35184 Elmshorn Germany 25336
    95 Site Reference ID/Investigator# 34809 Erfurt Germany 99096
    96 Site Reference ID/Investigator# 35096 Erfurt Germany 99096
    97 Site Reference ID/Investigator# 35191 Erfurt Germany 99096
    98 Site Reference ID/Investigator# 34821 Erlangen Germany 91056
    99 Site Reference ID/Investigator# 35196 Essen Germany 45326
    100 Site Reference ID/Investigator# 35199 Essen Germany 45356
    101 Site Reference ID/Investigator# 35202 Feldafing Germany 82340
    102 Site Reference ID/Investigator# 35205 Flensburg Germany 24937
    103 Site Reference ID/Investigator# 34833 Forchheim Germany 91301
    104 Site Reference ID/Investigator# 35210 Frankenberg Germany 09669
    105 Site Reference ID/Investigator# 34849 Frankfurt Germany 15230
    106 Site Reference ID/Investigator# 34840 Frankfurt Germany 60596
    107 Site Reference ID/Investigator# 34843 Frankfurt Germany 60596
    108 Site Reference ID/Investigator# 35213 Fraureuth Germany 08427
    109 Site Reference ID/Investigator# 35219 Freiberg Germany 09599
    110 Site Reference ID/Investigator# 34854 Freiburg Germany 79098
    111 Site Reference ID/Investigator# 35221 Freiburg Germany 79104
    112 Site Reference ID/Investigator# 34861 Freiburg Germany 79106
    113 Site Reference ID/Investigator# 35101 Freystadt Germany 92342
    114 Site Reference ID/Investigator# 35224 Friedrichroda Germany 99894
    115 Site Reference ID/Investigator# 34879 Gelsenkirchen Germany 45881
    116 Site Reference ID/Investigator# 34883 Gera Germany 07545
    117 Site Reference ID/Investigator# 34887 Giessen Germany 35392
    118 Site Reference ID/Investigator# 35491 Gosheim Germany 78559
    119 Site Reference ID/Investigator# 34896 Goslar Germany 38642
    120 Site Reference ID/Investigator# 34901 Greifswald Germany 17489
    121 Site Reference ID/Investigator# 35496 Greifswald Germany 17489
    122 Site Reference ID/Investigator# 34904 Greifswald Germany 17491
    123 Site Reference ID/Investigator# 102217 Gross Ammensleben Germany 39326
    124 Site Reference ID/Investigator# 35498 Guben Germany 3172
    125 Site Reference ID/Investigator# 34912 Guestrow Germany 18273
    126 Site Reference ID/Investigator# 35503 Hagen Germany 58089
    127 Site Reference ID/Investigator# 34937 Halle Germany 06108
    128 Site Reference ID/Investigator# 34940 Halle Germany 06108
    129 Site Reference ID/Investigator# 34922 Halle Germany 06112
    130 Site Reference ID/Investigator# 34944 Halle Germany 06120
    131 Site Reference ID/Investigator# 34932 Halle Germany 06128
    132 Site Reference ID/Investigator# 35444 Hamburg Germany 20144
    133 Site Reference ID/Investigator# 35441 Hamburg Germany 20148
    134 Site Reference ID/Investigator# 34970 Hamburg Germany 20251
    135 Site Reference ID/Investigator# 34952 Hamburg Germany 20355
    136 Site Reference ID/Investigator# 34958 Hamburg Germany 21075
    137 Site Reference ID/Investigator# 35452 Hamburg Germany 22081
    138 Site Reference ID/Investigator# 35007 Hamburg Germany 22089
    139 Site Reference ID/Investigator# 35000 Hamburg Germany 22119
    140 Site Reference ID/Investigator# 34961 Hamburg Germany 22147
    141 Site Reference ID/Investigator# 35449 Hamburg Germany 22179
    142 Site Reference ID/Investigator# 34955 Hamburg Germany 22415
    143 Site Reference ID/Investigator# 34998 Hamburg Germany 22459
    144 Site Reference ID/Investigator# 34994 Hamburg Germany 22523
    145 Site Reference ID/Investigator# 34983 Hamburg Germany 22609
    146 Site Reference ID/Investigator# 34986 Hamburg Germany 22609
    147 Site Reference ID/Investigator# 35111 Hamburg Germany 22609
    148 Site Reference ID/Investigator# 34974 Hamburg Germany 22767
    149 Site Reference ID/Investigator# 35019 Hanau Germany 63450
    150 Site Reference ID/Investigator# 33712 Hanover Germany 30159
    151 Site Reference ID/Investigator# 35025 Hanover Germany 30159
    152 Site Reference ID/Investigator# 33792 Harrislee Germany 24955
    153 Site Reference ID/Investigator# 35459 Haseluenne Germany 49740
    154 Site Reference ID/Investigator# 102215 Heidelberg Germany 69120
    155 Site Reference ID/Investigator# 33798 Heidelberg Germany 69120
    156 Site Reference ID/Investigator# 35119 Heidelberg Germany 69120
    157 Site Reference ID/Investigator# 33801 Heidelberg Germany 69121
    158 Site Reference ID/Investigator# 33808 Heidelberg Germany 69121
    159 Site Reference ID/Investigator# 35464 Heidenheim Germany 89520
    160 Site Reference ID/Investigator# 33818 Heilbad Heiligenstadt Germany 37308
    161 Site Reference ID/Investigator# 33825 Herrsching Germany 82211
    162 Site Reference ID/Investigator# 33842 Hofheim Germany 65719
    163 Site Reference ID/Investigator# 33834 Hof Germany 95028
    164 Site Reference ID/Investigator# 33845 Hohenfelde Germany 18209
    165 Site Reference ID/Investigator# 33855 Illertissen Germany 89257
    166 Site Reference ID/Investigator# 33858 Immenstadt Germany 87509
    167 Site Reference ID/Investigator# 35479 Ingolstadt Germany 85049
    168 Site Reference ID/Investigator# 51882 Jena Germany 07743
    169 Site Reference ID/Investigator# 33942 Juelich Germany 52428
    170 Site Reference ID/Investigator# 33946 Kahla Germany 07768
    171 Site Reference ID/Investigator# 35125 Kahla Germany 07768
    172 Site Reference ID/Investigator# 33950 Kaiserslautern Germany 67655
    173 Site Reference ID/Investigator# 33956 Karlsruhe Germany 76133
    174 Site Reference ID/Investigator# 33961 Karlsruhe Germany 76133
    175 Site Reference ID/Investigator# 33964 Kassel Germany 34131
    176 Site Reference ID/Investigator# 34002 Koenigs Wusterhausen Germany 15711
    177 Site Reference ID/Investigator# 34008 Kressbronn Germany 88079
    178 Site Reference ID/Investigator# 34084 Kronach Germany 96317
    179 Site Reference ID/Investigator# 34005 Lahr Germany 77933
    180 Site Reference ID/Investigator# 35245 Landau Germany 76829
    181 Site Reference ID/Investigator# 34112 Leipzig Germany 04109
    182 Site Reference ID/Investigator# 34106 Leipzig Germany 04129
    183 Site Reference ID/Investigator# 34109 Leipzig Germany 04207
    184 Site Reference ID/Investigator# 34100 Leipzig Germany 04299
    185 Site Reference ID/Investigator# 35254 Lippstadt Germany 59555
    186 Site Reference ID/Investigator# 35306 Ludwigsfelde Germany 14974
    187 Site Reference ID/Investigator# 35262 Ludwigshafen Germany 67069
    188 Site Reference ID/Investigator# 34136 Luebeck Germany 23564
    189 Site Reference ID/Investigator# 34139 Lueneburg Germany 21335
    190 Site Reference ID/Investigator# 34147 Magdeburg Germany 39104
    191 Site Reference ID/Investigator# 34150 Magdeburg Germany 39104
    192 Site Reference ID/Investigator# 35276 Mainz Germany 55116
    193 Site Reference ID/Investigator# 34192 Marktredwitz Germany 95615
    194 Site Reference ID/Investigator# 34196 Marl Germany 45768
    195 Site Reference ID/Investigator# 34200 Meissen Germany 01662
    196 Site Reference ID/Investigator# 35285 Menz Germany 39175
    197 Site Reference ID/Investigator# 35287 Minden Germany 32429
    198 Site Reference ID/Investigator# 34208 Mittelherwigsdorf Germany 02763
    199 Site Reference ID/Investigator# 34218 Moenchengladbach Germany 41061
    200 Site Reference ID/Investigator# 34213 Moenchengladbach Germany 41199
    201 Site Reference ID/Investigator# 34221 Moenkeberg Germany 24248
    202 Site Reference ID/Investigator# 34224 Muehlhausen Germany 99974
    203 Site Reference ID/Investigator# 35292 Muelheim Germany 45468
    204 Site Reference ID/Investigator# 34229 Muellheim Germany 79379
    205 Site Reference ID/Investigator# 34048 Muenster Germany 48149
    206 Site Reference ID/Investigator# 34040 Munich Germany 80639
    207 Site Reference ID/Investigator# 35295 Munich Germany 81377
    208 Site Reference ID/Investigator# 34232 Munich Germany 81547
    209 Site Reference ID/Investigator# 34235 Munich Germany 81547
    210 Site Reference ID/Investigator# 35298 Munich Germany 81667
    211 Site Reference ID/Investigator# 34043 Munich Germany 81925
    212 Site Reference ID/Investigator# 34052 Naunhof Germany 04683
    213 Site Reference ID/Investigator# 34061 Neubrandenburg Germany 17033
    214 Site Reference ID/Investigator# 34064 Neuburg Germany 86633
    215 Site Reference ID/Investigator# 34071 Neumuenster Germany 24534
    216 Site Reference ID/Investigator# 35313 Neuss Germany 41460
    217 Site Reference ID/Investigator# 34076 Neustadt Germany 67434
    218 Site Reference ID/Investigator# 35321 Niederbrombach Germany 55767
    219 Site Reference ID/Investigator# 34080 Niefern-Oeschelbronn Germany 75223
    220 Site Reference ID/Investigator# 34158 Nienburg Germany 31582
    221 Site Reference ID/Investigator# 34173 Oelsnitz Germany 09376
    222 Site Reference ID/Investigator# 34176 Offenburg Germany 77652
    223 Site Reference ID/Investigator# 33492 Oldenburg Germany 26121
    224 Site Reference ID/Investigator# 34718 Ostseebad Damp Germany 24351
    225 Site Reference ID/Investigator# 35335 Paderborn Germany 33098
    226 Site Reference ID/Investigator# 33508 Parchim Germany 19370
    227 Site Reference ID/Investigator# 35340 Passau Germany 94032
    228 Site Reference ID/Investigator# 33517 Pfullendorf Germany 88630
    229 Site Reference ID/Investigator# 67482 Pirna Germany 01796
    230 Site Reference ID/Investigator# 33523 Planegg Germany 82152
    231 Site Reference ID/Investigator# 33528 Plauen Germany 08523
    232 Site Reference ID/Investigator# 33470 Potsdam Germany 14467
    233 Site Reference ID/Investigator# 33466 Potsdam Germany 14469
    234 Site Reference ID/Investigator# 33476 Pruem Germany 54595
    235 Site Reference ID/Investigator# 33479 Puettlingen Germany 66346
    236 Site Reference ID/Investigator# 33484 Radebeul Germany 01445
    237 Site Reference ID/Investigator# 35347 Radebeul Germany 01445
    238 Site Reference ID/Investigator# 35136 Ratingen Germany 40882
    239 Site Reference ID/Investigator# 33488 Ratzeburg Germany 23909
    240 Site Reference ID/Investigator# 33890 Regensburg Germany 93049
    241 Site Reference ID/Investigator# 33883 Regensburg Germany 93051
    242 Site Reference ID/Investigator# 33886 Regensburg Germany 93051
    243 Site Reference ID/Investigator# 33897 Reken Germany 48734
    244 Site Reference ID/Investigator# 33902 Rendsburg Germany 24768
    245 Site Reference ID/Investigator# 33907 Rheine Germany 48431
    246 Site Reference ID/Investigator# 35355 Rickenbach Germany 79736
    247 Site Reference ID/Investigator# 33911 Riesa Germany 01589
    248 Site Reference ID/Investigator# 33914 Rinteln Germany 31737
    249 Site Reference ID/Investigator# 33923 Rostock Germany 18059
    250 Site Reference ID/Investigator# 33927 Rostock Germany 18059
    251 Site Reference ID/Investigator# 33931 Rothenburg Germany 02929
    252 Site Reference ID/Investigator# 35362 Ruedersdorf Germany 15562
    253 Site Reference ID/Investigator# 34016 Saarbruecken Germany 66111
    254 Site Reference ID/Investigator# 34023 Salzwedel Germany 29410
    255 Site Reference ID/Investigator# 34027 Sande Germany 26452
    256 Site Reference ID/Investigator# 33534 Schneeberg Germany 08289
    257 Site Reference ID/Investigator# 33539 Schramberg Germany 78713
    258 Site Reference ID/Investigator# 33542 Schutterwald Germany 77746
    259 Site Reference ID/Investigator# 35371 Schwandorf Germany 92421
    260 Site Reference ID/Investigator# 33549 Schwerin Germany 19053
    261 Site Reference ID/Investigator# 35376 Schwerin Germany 19053
    262 Site Reference ID/Investigator# 33555 Schwerte Germany 58239
    263 Site Reference ID/Investigator# 33559 Seesen Germany 38723
    264 Site Reference ID/Investigator# 33563 Senden Germany 48308
    265 Site Reference ID/Investigator# 35380 Singen Germany 78224
    266 Site Reference ID/Investigator# 33567 Sinsheim Germany 74889
    267 Site Reference ID/Investigator# 33572 Soltau Germany 29614
    268 Site Reference ID/Investigator# 33577 Spremberg Germany 03130
    269 Site Reference ID/Investigator# 35383 St. Martin Germany 67487
    270 Site Reference ID/Investigator# 33588 Stadthagen Germany 31655
    271 Site Reference ID/Investigator# 33592 Steinhagen Germany 33803
    272 Site Reference ID/Investigator# 33604 Stuttgart Germany 70178
    273 Site Reference ID/Investigator# 33607 Stuttgart Germany 70178
    274 Site Reference ID/Investigator# 33611 Stuttgart Germany 70199
    275 Site Reference ID/Investigator# 33598 Stuttgart Germany 70372
    276 Site Reference ID/Investigator# 35389 Suhl Germany 98529
    277 Site Reference ID/Investigator# 35391 Tegernau Germany 79692
    278 Site Reference ID/Investigator# 33625 Torgelow Germany 17358
    279 Site Reference ID/Investigator# 33637 Ueberlingen-Nussdorf Germany 88662
    280 Site Reference ID/Investigator# 35395 Uffenheim Germany 97215
    281 Site Reference ID/Investigator# 33721 Ulm Germany 89073
    282 Site Reference ID/Investigator# 33724 Ulm Germany 89073
    283 Site Reference ID/Investigator# 33734 Viersen Germany 41747
    284 Site Reference ID/Investigator# 33737 Villingen-Schwenningen Germany 78054
    285 Site Reference ID/Investigator# 35397 Voehringen Germany 72189
    286 Site Reference ID/Investigator# 33742 Waltrop Germany 45731
    287 Site Reference ID/Investigator# 33749 Weener Germany 26826
    288 Site Reference ID/Investigator# 33751 Weissenfels Germany 06667
    289 Site Reference ID/Investigator# 33852 Welzow Germany 03119
    290 Site Reference ID/Investigator# 35404 Wiefelstede Germany 26215
    291 Site Reference ID/Investigator# 33761 Wiesbaden Germany 65189
    292 Site Reference ID/Investigator# 35408 Wiesbaden Germany 65189
    293 Site Reference ID/Investigator# 33765 Wiesbaden Germany 65191
    294 Site Reference ID/Investigator# 35413 Wiesbaden Germany 65191
    295 Site Reference ID/Investigator# 33772 Wilhelmshaven Germany 26382
    296 Site Reference ID/Investigator# 33780 Wittlich Germany 54516
    297 Site Reference ID/Investigator# 33718 Wuerzburg Germany 97070
    298 Site Reference ID/Investigator# 35420 Wuppertal Germany 42105
    299 Site Reference ID/Investigator# 33864 Zerbst Germany 39261
    300 Site Reference ID/Investigator# 33867 Zeven Germany 27404
    301 Site Reference ID/Investigator# 33873 Zwickau Germany 08056
    302 Site Reference ID/Investigator# 33876 Zwickau Germany 08060
    303 Site Reference ID/Investigator# 33880 Zwiesel Germany 94227

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)

    Investigators

    • Study Director: Bianca Wittig, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01077258
    Other Study ID Numbers:
    • P10-448
    First Posted:
    Mar 1, 2010
    Last Update Posted:
    Apr 25, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by AbbVie (prior sponsor, Abbott)
    Safety
    Long-term observation
    Routine Clinical Setting
    Rheumatoid Arthritis
    Effectiveness
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Period Title: Overall Study
    STARTED 4208
    COMPLETED 1640
    NOT COMPLETED 2568

    Baseline Characteristics

    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Overall Participants 4208
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.6
    (13.2)
    Gender (participants) [Number]
    Female
    3199
    76%
    Male
    958
    22.8%
    Region of Enrollment (participants) [Number]
    Germany
    4208
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Disease Activity Score (DAS) 28
    Description The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 3 (n=2620)
    -1.5
    (1.3)
    Month 6 (n=2243
    -1.8
    (1.4)
    Month 9 (n=1877)
    -1.9
    (1.4)
    Month 12 (n=1776)
    -2.0
    (1.4)
    Month 18 (n=1519)
    -2.1
    (1.4)
    Month 24 (n=1248)
    -2.2
    (1.4)
    2. Primary Outcome
    Title Percentage of Participants in DAS28 Remission
    Description Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
    Time Frame Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 3 (n=2620)
    18.1
    0.4%
    Month 6 (n=2243)
    22.0
    0.5%
    Month 9 (n=1877)
    26.1
    0.6%
    Month 12 (n=1776)
    27.2
    0.6%
    Month 18 (n=1519)
    29.8
    0.7%
    Month 24 (n=1248)
    34.6
    0.8%
    3. Secondary Outcome
    Title Percentage of Participants With a Significant Therapeutic Response
    Description Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 3 (n=2620)
    38.9
    0.9%
    Month 6 (n=2243)
    49.1
    1.2%
    Month 9 (n=1877)
    54.7
    1.3%
    Month 12 (n=1776)
    56.3
    1.3%
    Month 18 (n=1519)
    60.1
    1.4%
    Month 24 (n=1248)
    61.9
    1.5%
    4. Secondary Outcome
    Title Percentage of Participants With Low, Moderate and High Disease Activity
    Description The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point
    Arm/Group Title Month 0 Month 3 Month 6 Month 9 Month 12 Month 18 Month 24
    Arm/Group Description Baseline 3 months after inclusion 6 months after inclusion 9 months after inclusion 12 months after inclusion 18 months after inclusion 24 months after inclusion
    Measure Participants 2950 2620 2243 1877 1776 1519 1248
    Low disease activity
    0.0
    0%
    30.2
    NaN
    36.5
    NaN
    41.8
    NaN
    43.7
    NaN
    46.7
    NaN
    51.4
    NaN
    Moderate disease ctivity
    35.7
    0.8%
    45.9
    NaN
    45.6
    NaN
    43.9
    NaN
    43.1
    NaN
    41.7
    NaN
    37.7
    NaN
    High disease activity
    64.3
    1.5%
    23.9
    NaN
    17.9
    NaN
    14.3
    NaN
    13.2
    NaN
    11.6
    NaN
    10.9
    NaN
    5. Secondary Outcome
    Title Erythrocyte Sedimentation Rate (ESR) Over Time
    Description Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=2900)
    32.1
    (22.0)
    Month 3 (n=2684)
    23.2
    (20.2)
    Month 6 (n=2259)
    22.1
    (19.1)
    Month 9 (n=1910)
    21.6
    (18.2)
    Month 12 (n=1805)
    21.4
    (17.9)
    Month 18 (n=1515)
    21.0
    (17.5)
    Month 24 (n=1263)
    21.2
    (18.7)
    6. Secondary Outcome
    Title C-Reactive Protein (CRP) Levels Over Time
    Description C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=2899)
    20.0
    (36.6)
    Month 3 (n=2677)
    11.9
    (31.9)
    Month 6 (n=2289)
    9.2
    (19.5)
    Month 9 (n=1936)
    8.1
    (15.8)
    Month 12 (n=1813)
    8.0
    (17.7)
    Month 18 (n=1537)
    6.6
    (11.9)
    Month 24 (n=1297)
    5.7
    (10.9)
    7. Secondary Outcome
    Title Tender Joint Count (TJC) Over Time
    Description Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=2950)
    10.6
    (6.7)
    Month 3 (n=2778)
    5.4
    (6.1)
    Month 6 (n=2393)
    4.3
    (5.4)
    Month 9 (n=2010)
    3.9
    (5.4)
    Month 12 (n=1886)
    3.6
    (5.0)
    Month 18 (n=1621)
    3.4
    (4.9)
    Month 24 (n=1339)
    3.1
    (4.5)
    8. Secondary Outcome
    Title Swollen Joint Count (SJC) Over Time
    Description Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=2950)
    7.7
    (5.6)
    Month 3 (n=2768)
    3.7
    (4.6)
    Month 6 (n=2375)
    3.0
    (4.1)
    Month 9 (n=2003)
    2.6
    (3.8)
    Month 12 (n=1868)
    2.4
    (3.7)
    Month 18 (n=1609)
    2.1
    (3.4)
    Month 24 (n=1326)
    2.0
    (3.4)
    9. Secondary Outcome
    Title Hannover Functional Questionnaire (FFbH) Over Time
    Description A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=2938)
    61.9
    (22.4)
    Month 3 (n=2755)
    68.4
    (22.5)
    Month 6 (n=2369)
    70.4
    (22.2)
    Month 9 (n=1997)
    71.3
    (22.5)
    Month 12 (n=1882)
    71.9
    (22.4)
    Month 18 (n=1623)
    72.4
    (22.5)
    Month 24 (n=1341)
    72.7
    (22.7)
    10. Secondary Outcome
    Title Patients Global Assessment of Disease Activity Over Time
    Description Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
    Time Frame Baseline and Months 3, 6, 9, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=2950)
    6.3
    (1.9)
    Month 3 (n=2731)
    4.7
    (2.2)
    Month 6 (n=2353)
    4.4
    (2.1)
    Month 9 (n=1975)
    4.2
    (2.1)
    Month 12 (n=1869)
    4.1
    (2.1)
    Month 18 (n=1609)
    4.0
    (2.1)
    Month 24 (n=1339)
    3.8
    (2.1)
    11. Secondary Outcome
    Title Participants Assessment of Fatigue Over Time
    Description Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
    Time Frame Baseline and Month 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=2940)
    5.8
    (2.5)
    Month 3 (n=2727)
    4.5
    (2.7)
    Month 6 (n=2351)
    4.2
    (2.6)
    Month 9 (n=1976)
    4.0
    (2.6)
    Month 12 (n=1864)
    4.0
    (2.6)
    Month 18 (n=1608)
    3.9
    (2.6)
    Month 24 (n=1335)
    3.7
    (2.6)
    12. Secondary Outcome
    Title Participants Assessment of Pain Over Time
    Description Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=2942)
    6.4
    (2.1)
    Month 3 (n=2732)
    4.5
    (2.4)
    Month 6 (n=2356)
    4.2
    (2.4)
    Month 9 (n=1973)
    4.1
    (2.4)
    Month 12 (n=1866)
    3.9
    (2.4)
    Month 18 (n=1609)
    3.9
    (2.4)
    Month 24 (n=1339)
    3.7
    (2.4)
    13. Secondary Outcome
    Title Percentage of Participants With Impairment in Daily Activities
    Description Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.
    Time Frame Baseline and Months 3, 6, 9, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point
    Arm/Group Title Month 0 Month 3 Month 6 Month 9 Month 18 Month 24
    Arm/Group Description Baseline 3 months after inclusion 6 months after inclusion 9 months after inclusion 18 months after inclusion 24 months after inclusion
    Measure Participants 2864 2648 2288 1914 1513 1302
    No days of impairment
    19.7
    0.5%
    35.8
    NaN
    40.3
    NaN
    45.7
    NaN
    51.4
    NaN
    52.1
    NaN
    Less than 7 days of impairment
    28.5
    0.7%
    36.3
    NaN
    35.5
    NaN
    33.3
    NaN
    30.0
    NaN
    30.4
    NaN
    7 to 14 days of impairment
    28.8
    0.7%
    16.1
    NaN
    14.9
    NaN
    13.2
    NaN
    12.0
    NaN
    10.8
    NaN
    More than 14 days of impairment
    23.0
    0.5%
    11.7
    NaN
    9.4
    NaN
    7.8
    NaN
    6.7
    NaN
    6.7
    NaN
    14. Secondary Outcome
    Title Number of Days Missed From Work Due to Rheumatoid Arthritis
    Description Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.
    Time Frame Baseline and Months 6, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set participants who were employed and with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Month 0 (n=1168)
    20.6
    (52.4)
    Month 6 (n=938)
    9.9
    (33.2)
    Month 12 (n=728)
    4.4
    (21.3)
    Month 18 (n=604)
    5.2
    (27.1)
    Month 24 (n=507)
    3.8
    (17.9)
    15. Secondary Outcome
    Title Percentage of Participants With In-patient Hospitalization
    Description The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.
    Time Frame Month 6, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    Measure Participants 2950
    Baseline (n=2893)
    21.6
    0.5%
    Month 6 (n=2293)
    7.2
    0.2%
    Month 12 (n=1844)
    5.8
    0.1%
    Month 18 (n=1584)
    5.4
    0.1%
    Month 24 (n=1320)
    3.6
    0.1%
    16. Secondary Outcome
    Title Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
    Description
    Time Frame Baseline and Months 3, 6, 9, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set with available data at each time point (indicated by n)
    Arm/Group Title Month 0 Month 3 Month 6 Month 9 Month 12 Month 18 Month 24
    Arm/Group Description Baseline 3 months after inclusion 6 months after inclusion 9 months after inclusion 12 months after inclusion 18 months after inclusion 24 months after inclusion
    Measure Participants 2950 2820 2415 2041 1917 1651 1372
    Methotrexate
    54.0
    1.3%
    52.3
    NaN
    53.2
    NaN
    53.1
    NaN
    53.2
    NaN
    52.9
    NaN
    51.0
    NaN
    Sulfasalazine
    6.2
    0.1%
    3.7
    NaN
    3.6
    NaN
    3.2
    NaN
    3.5
    NaN
    3.3
    NaN
    2.8
    NaN
    Hydroxychloroquine/Chloroquine
    2.5
    0.1%
    2.0
    NaN
    1.6
    NaN
    1.2
    NaN
    1.2
    NaN
    1.3
    NaN
    1.4
    NaN
    Leflunomide
    22.1
    0.5%
    18.0
    NaN
    15.9
    NaN
    15.3
    NaN
    15.0
    NaN
    14.1
    NaN
    12.7
    NaN
    Other disease-modifying antirheumatic drug
    4.5
    0.1%
    2.8
    NaN
    2.5
    NaN
    2.3
    NaN
    2.0
    NaN
    2.2
    NaN
    2.1
    NaN
    Analgesics
    21.8
    0.5%
    15.4
    NaN
    14.9
    NaN
    14.0
    NaN
    12.9
    NaN
    11.7
    NaN
    12.0
    NaN
    Non-steroidal anti-inflammatory drug
    46.1
    1.1%
    36.9
    NaN
    34.2
    NaN
    33.9
    NaN
    32.7
    NaN
    31.7
    NaN
    30.5
    NaN
    Cyclo-oxygenase 2 (COX-2) Inhibitors
    12.4
    0.3%
    10.4
    NaN
    10.2
    NaN
    9.6
    NaN
    9.2
    NaN
    9.6
    NaN
    9.7
    NaN
    Systemic glucocorticoids
    80.9
    1.9%
    73.4
    NaN
    69.1
    NaN
    65.7
    NaN
    62.1
    NaN
    58.8
    NaN
    57.4
    NaN

    Adverse Events

    Time Frame Adverse events (AEs) were collected throughout the 24-month period.
    Adverse Event Reporting Description During this non-interventional study, clinicians were asked to report AEs considered to be related to the study medication for all patients who received at least one dose of adalimumab (safety set; N = 4208).
    Arm/Group Title Rheumatoid Arthritis
    Arm/Group Description Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
    All Cause Mortality
    Rheumatoid Arthritis
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Rheumatoid Arthritis
    Affected / at Risk (%) # Events
    Total 245/4208 (5.8%)
    Blood and lymphatic system disorders
    Anemia hemolytic autoimmune 1/4208 (0%)
    Leukopenia 1/4208 (0%)
    Pancytopenia 1/4208 (0%)
    Thrombocytopenia 1/4208 (0%)
    Cardiac disorders
    Cardiac failure 3/4208 (0.1%)
    Tachycardia 3/4208 (0.1%)
    Angina pectoris 2/4208 (0%)
    Congestive cardiomyopathy 2/4208 (0%)
    Myocardial infarction 2/4208 (0%)
    Palpitations 2/4208 (0%)
    Acute myocardial infarction 1/4208 (0%)
    Atrial tachycardia 1/4208 (0%)
    Pericardial effusion 1/4208 (0%)
    Pericarditis 1/4208 (0%)
    Eye disorders
    Eyelid edema 3/4208 (0.1%)
    Cataract 1/4208 (0%)
    Eyelid exfoliation 1/4208 (0%)
    Eyelids pruritus 1/4208 (0%)
    Visual acuity reduced 1/4208 (0%)
    Xerophthalmia 1/4208 (0%)
    Gastrointestinal disorders
    Nausea 5/4208 (0.1%)
    Diarrhea 4/4208 (0.1%)
    Abdominal discomfort 2/4208 (0%)
    Stomatitis 2/4208 (0%)
    Vomiting 2/4208 (0%)
    Abdominal pain lower 1/4208 (0%)
    Abdominal pain upper 1/4208 (0%)
    Acute abdomen 1/4208 (0%)
    Aphthous stomatitis 1/4208 (0%)
    Gastric ulcer 1/4208 (0%)
    Gastritis 1/4208 (0%)
    Gastroesophageal reflux disease 1/4208 (0%)
    Glossodynia 1/4208 (0%)
    Hematochezia 1/4208 (0%)
    Hypoesthesia oral 1/4208 (0%)
    Mouth ulceration 1/4208 (0%)
    Mouth edema 1/4208 (0%)
    Oral pain 1/4208 (0%)
    Pancreatitis acute 1/4208 (0%)
    Swollen tongue 1/4208 (0%)
    Tongue blistering 1/4208 (0%)
    Tongue disorder 1/4208 (0%)
    General disorders
    Infection site erythema 11/4208 (0.3%)
    Injection site pruritus 9/4208 (0.2%)
    Injection site reaction 5/4208 (0.1%)
    Unevaluable event 5/4208 (0.1%)
    Pyrexia 4/4208 (0.1%)
    Injection site pain 3/4208 (0.1%)
    Edema 2/4208 (0%)
    Fatigue 2/4208 (0%)
    Inflammation 2/4208 (0%)
    Injection site swelling 2/4208 (0%)
    Injection site urticaria 2/4208 (0%)
    Adverse drug reaction 1/4208 (0%)
    Chills 1/4208 (0%)
    Condition aggravated 1/4208 (0%)
    Death 1/4208 (0%)
    Disease recurrence 1/4208 (0%)
    Injection site induration 1/4208 (0%)
    Injection site scab 1/4208 (0%)
    Local swelling 1/4208 (0%)
    Malaise 1/4208 (0%)
    Mucosal dryness 1/4208 (0%)
    Obstruction 1/4208 (0%)
    Peripheral edema 1/4208 (0%)
    Hepatobiliary disorders
    Hepatotoxicity 1/4208 (0%)
    Immune system disorders
    Hypersensitivity 1/4208 (0%)
    Infections and infestations
    Nasopharyngitis 11/4208 (0.3%)
    Pneumonia 10/4208 (0.2%)
    Bronchitis 6/4208 (0.1%)
    Urinary tract infection 5/4208 (0.1%)
    Herpes zoster 4/4208 (0.1%)
    Oral herpes 4/4208 (0.1%)
    Bronchopneumonia 3/4208 (0.1%)
    Cellulitis 3/4208 (0.1%)
    Laryngitis 3/4208 (0.1%)
    Rash pustular 3/4208 (0.1%)
    Sinusitis 3/4208 (0.1%)
    Upper respiratory tract infection 3/4208 (0.1%)
    Gastrointestinal infection 2/4208 (0%)
    Infection 2/4208 (0%)
    Localized infection 2/4208 (0%)
    Respiratory tract infection 2/4208 (0%)
    Sepsis 2/4208 (0%)
    Tonsillitis 2/4208 (0%)
    Abscess limb 1/4208 (0%)
    Acute tonsillitis 1/4208 (0%)
    Chronic sinusitis 1/4208 (0%)
    Device-related infection 1/4208 (0%)
    Diverticulitis 1/4208 (0%)
    Encephalitis viral 1/4208 (0%)
    Fungal infection 1/4208 (0%)
    Furuncle 1/4208 (0%)
    Gastroenteritis 1/4208 (0%)
    Genital herpes 1/4208 (0%)
    Herpes simplex 1/4208 (0%)
    Herpes virus infection 1/4208 (0%)
    Infection susceptibility increased 1/4208 (0%)
    Mastoiditis 1/4208 (0%)
    Otitis media 1/4208 (0%)
    Pneumocystis jiroveci pneumonia 1/4208 (0%)
    Pneumonia staphylococcal 1/4208 (0%)
    Pyelonephritis 1/4208 (0%)
    Pyothorax 1/4208 (0%)
    Sinobronchitis 1/4208 (0%)
    Skin infection 1/4208 (0%)
    Staphylococcal infection 1/4208 (0%)
    Tooth abscess 1/4208 (0%)
    Vulvovaginal mycotic infection 1/4208 (0%)
    Injury, poisoning and procedural complications
    Rib fracture 3/4208 (0.1%)
    Foot fracture 2/4208 (0%)
    Humerus fracture 2/4208 (0%)
    Thoracic vertebral fracture 2/4208 (0%)
    Ankle fracture 1/4208 (0%)
    Bloody airway discharge 1/4208 (0%)
    Femur fracture 1/4208 (0%)
    Limb injury 1/4208 (0%)
    Spinal fracture 1/4208 (0%)
    Tendon rupture 1/4208 (0%)
    Wound secretion 1/4208 (0%)
    Investigations
    Arthroscopy 2/4208 (0%)
    Antinuclar antibody positive 1/4208 (0%)
    Arteriogram coronary 1/4208 (0%)
    DNA antibody positive 1/4208 (0%)
    Electrophoresis protein abnormal 1/4208 (0%)
    Hepatic enzyme increased 1/4208 (0%)
    Transaminase increased 1/4208 (0%)
    Metabolism and nutrition disorders
    Electrolyte imbalance 1/4208 (0%)
    Musculoskeletal and connective tissue disorders
    Arthritis 3/4208 (0.1%)
    Joint effusion 3/4208 (0.1%)
    Bursitis 1/4208 (0%)
    Fasciitis 1/4208 (0%)
    Lupus-like syndrome 1/4208 (0%)
    Muscle spasms 1/4208 (0%)
    Muscular weakness 1/4208 (0%)
    Myalgia 1/4208 (0%)
    Neck pain 1/4208 (0%)
    Osteonecrosis 1/4208 (0%)
    Osteoporosis 1/4208 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin cancer 2/4208 (0%)
    Skin papilloma 2/4208 (0%)
    Breast cancer 1/4208 (0%)
    Bronchial carcinoma 1/4208 (0%)
    Gastric cancer 1/4208 (0%)
    Large intestine cancer 1/4208 (0%)
    Laryngeal cancer 1/4208 (0%)
    Metastases to central nervous system 1/4208 (0%)
    Metastases to liver 1/4208 (0%)
    Papillary tumor of renal pelvis 1/4208 (0%)
    Squamous cell carcinoma 1/4208 (0%)
    Transitional cell carcinoma 1/4208 (0%)
    Urteric cancer local 1/4208 (0%)
    Nervous system disorders
    Dizziness 6/4208 (0.1%)
    Cerebrovascular accident 3/4208 (0.1%)
    Headache 3/4208 (0.1%)
    Somnolence 3/4208 (0.1%)
    Anosmia 1/4208 (0%)
    Aphasia 1/4208 (0%)
    Carotid artery stenosis 1/4208 (0%)
    Hemiparesis 1/4208 (0%)
    Hypogeusia 1/4208 (0%)
    Neuralgia 1/4208 (0%)
    Neurological symptom 1/4208 (0%)
    Polyneuropathy 1/4208 (0%)
    Transient ischemic attack 1/4208 (0%)
    Psychiatric disorders
    Anxiety 2/4208 (0%)
    Restlessness 2/4208 (0%)
    Insomnia 1/4208 (0%)
    Panic reaction 1/4208 (0%)
    Sleep disorder 1/4208 (0%)
    Renal and urinary disorders
    Bladder tamponade 1/4208 (0%)
    Chromaturia 1/4208 (0%)
    Cystitis hemorrhagic 1/4208 (0%)
    Micturition urgency 1/4208 (0%)
    Nephritis 1/4208 (0%)
    Nephrolithiasis 1/4208 (0%)
    Reproductive system and breast disorders
    Erectile dysfunction 1/4208 (0%)
    Uterine prolapse 1/4208 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 14/4208 (0.3%)
    Dyspnea 7/4208 (0.2%)
    Pleural effusion 2/4208 (0%)
    Pulmonary embolism 2/4208 (0%)
    Alveolitis 1/4208 (0%)
    Alveolitis allergic 1/4208 (0%)
    Dry throat 1/4208 (0%)
    Hypercapnia 1/4208 (0%)
    Interstitial lung disease 1/4208 (0%)
    Oropharyngeal pain 1/4208 (0%)
    Pleurisy 1/4208 (0%)
    Pneumothorax 1/4208 (0%)
    Respiratory distress 1/4208 (0%)
    Throat irritation 1/4208 (0%)
    Upper airway obstruction 1/4208 (0%)
    Skin and subcutaneous tissue disorders
    Rash 10/4208 (0.2%)
    Alopecia 6/4208 (0.1%)
    Pruritus 5/4208 (0.1%)
    Dermatitis allergic 4/4208 (0.1%)
    Eczema 3/4208 (0.1%)
    Pruritus generalized 3/4208 (0.1%)
    Rash pruritic 3/4208 (0.1%)
    Erythema 2/4208 (0%)
    Nail discoloration 2/4208 (0%)
    Pustular psoriasis 2/4208 (0%)
    Skin reaction 2/4208 (0%)
    Acne 1/4208 (0%)
    Angioedema 1/4208 (0%)
    Cutaneous vasculitis 1/4208 (0%)
    Dermatitis acneiform 1/4208 (0%)
    Dry skin 1/4208 (0%)
    Lichenoid keratosis 1/4208 (0%)
    Psoriasis 1/4208 (0%)
    Rash generalized 1/4208 (0%)
    Skin discomfort 1/4208 (0%)
    Skin nodule 1/4208 (0%)
    Skin ulcer 1/4208 (0%)
    Swelling face 1/4208 (0%)
    Urticaria 1/4208 (0%)
    Surgical and medical procedures
    Hospitalization 6/4208 (0.1%)
    Joint arthroplasty 4/4208 (0.1%)
    Synovectomy 3/4208 (0.1%)
    Injection 2/4208 (0%)
    Surgery 2/4208 (0%)
    Antibiotic therapy 1/4208 (0%)
    Arthrodesis 1/4208 (0%)
    Esophageal operation 1/4208 (0%)
    Mastoid operation 1/4208 (0%)
    Mastoidectomy 1/4208 (0%)
    Rehabilitation therapy 1/4208 (0%)
    Sinus operation 1/4208 (0%)
    Spinal operation 1/4208 (0%)
    Stent placement 1/4208 (0%)
    Therapy cessation 1/4208 (0%)
    Vertebroplasty 1/4208 (0%)
    Vascular disorders
    Hypertension 3/4208 (0.1%)
    Flushing 1/4208 (0%)
    Venous thrombosis 1/4208 (0%)
    Venous thrombosis limb 1/4208 (0%)
    Other (Not Including Serious) Adverse Events
    Rheumatoid Arthritis
    Affected / at Risk (%) # Events
    Total 0/4208 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization AbbVie (prior sponsor, Abbott)
    Phone 800-633-9110
    Email
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01077258
    Other Study ID Numbers:
    • P10-448
    First Posted:
    Mar 1, 2010
    Last Update Posted:
    Apr 25, 2014
    Last Verified:
    Apr 1, 2014