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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01077258
First received: February 25, 2010
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change From Baseline in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants in DAS28 Remission [ Time Frame: Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants With a Significant Therapeutic Response [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With Low, Moderate and High Disease Activity [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]

    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.


  • Erythrocyte Sedimentation Rate (ESR) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.

  • C-Reactive Protein (CRP) Levels Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    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.

  • Tender Joint Count (TJC) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

  • Swollen Joint Count (SJC) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

  • Hannover Functional Questionnaire (FFbH) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]

    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.


  • Patients Global Assessment of Disease Activity Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: No ]
    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.

  • Participants Assessment of Fatigue Over Time [ Time Frame: Baseline and Month 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    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.

  • Participants Assessment of Pain Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Impairment in Daily Activities [ Time Frame: Baseline and Months 3, 6, 9, 18, and 24 ] [ Designated as safety issue: No ]
    Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.

  • Number of Days Missed From Work Due to Rheumatoid Arthritis [ Time Frame: Baseline and Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With In-patient Hospitalization [ Time Frame: Month 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]

Enrollment: 4208
Study Start Date: April 2004
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample: patients with rheumatoid arthritis who resided in Germany. German regulations state that all patients are eligible for non-interventional studies; there are no exclusions. Adult patients (≥ 18 years of age) with RA who were preparing to initiate adalimumab therapy according to the product label were eligible for study enrollment. The eligibility criteria below reflect the approved label as stated in the German Summary of Product Characteristics (SPC) for Humira.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077258

  Hide Study Locations
Locations
Germany
Site Reference ID/Investigator# 35036
Aachen, Germany, 52062
Site Reference ID/Investigator# 35510
Ahlen, Germany, 59227
Site Reference ID/Investigator# 35040
Ahrensburg, Germany, 22926
Site Reference ID/Investigator# 35043
Altenburg, Germany, 04600
Site Reference ID/Investigator# 35046
Altenholz, Germany, 24161
Site Reference ID/Investigator# 35049
Amberg, Germany, 92224
Site Reference ID/Investigator# 35057
Arnstadt, Germany, 99310
Site Reference ID/Investigator# 35520
Attendorn, Germany, 57439
Site Reference ID/Investigator# 33349
Augsburg, Germany, 86150
Site Reference ID/Investigator# 33361
Bad Abbach, Germany, 93077
Site Reference ID/Investigator# 33358
Bad Abbach, Germany, 93077
Site Reference ID/Investigator# 35142
Bad Aibling, Germany, 83043
Site Reference ID/Investigator# 35570
Bad Brambach, Germany, 8648
Site Reference ID/Investigator# 35573
Bad Bramstedt, Germany, 24576
Site Reference ID/Investigator# 33372
Bad Endbach, Germany, 35080
Site Reference ID/Investigator# 33382
Bad Iburg, Germany, 49186
Site Reference ID/Investigator# 33378
Bad Iburg, Germany, 49186
Site Reference ID/Investigator# 35575
Bad Kreuznach, Germany, 55543
Site Reference ID/Investigator# 33387
Bad Kreuznach, Germany, 55543
Site Reference ID/Investigator# 33391
Bad Liebenwerda, Germany, 04924
Site Reference ID/Investigator# 33396
Bad Muender, Germany, 31848
Site Reference ID/Investigator# 102216
Bad Nauheim, Germany, 61231
Site Reference ID/Investigator# 35578
Bad Neuenahr, Germany, 53474
Site Reference ID/Investigator# 33404
Bad Rappenau, Germany, 74906
Site Reference ID/Investigator# 51883
Bad Salzungen, Germany, 36433
Site Reference ID/Investigator# 33412
Bad Soden-Salmuenster, Germany, 63628
Site Reference ID/Investigator# 33425
Baden-Baden, Germany, 76530
Site Reference ID/Investigator# 33429
Bamberg, Germany, 96047
Site Reference ID/Investigator# 33438
Bautzen, Germany, 02625
Site Reference ID/Investigator# 33446
Bayreuth, Germany, 95445
Site Reference ID/Investigator# 33442
Bayreuth, Germany, 95445
Site Reference ID/Investigator# 35550
Berlin, Germany, 13595
Site Reference ID/Investigator# 33704
Berlin, Germany, 12435
Site Reference ID/Investigator# 35597
Berlin, Germany, 12161
Site Reference ID/Investigator# 35089
Berlin, Germany, 10117
Site Reference ID/Investigator# 33620
Berlin, Germany, 12207
Site Reference ID/Investigator# 35551
Berlin, Germany, 14163
Site Reference ID/Investigator# 34269
Berlin, Germany, 10961
Site Reference ID/Investigator# 35527
Berlin, Germany, 12161
Site Reference ID/Investigator# 34246
Berlin, Germany, 10719
Site Reference ID/Investigator# 34238
Berlin, Germany, 14199
Site Reference ID/Investigator# 33641
Berlin, Germany, 10117
Site Reference ID/Investigator# 33658
Berlin, Germany, 10435
Site Reference ID/Investigator# 33661
Berlin, Germany, 13437
Site Reference ID/Investigator# 33670
Berlin, Germany, 10369
Site Reference ID/Investigator# 33674
Berlin, Germany, 14109
Site Reference ID/Investigator# 33683
Berlin, Germany, 10777
Site Reference ID/Investigator# 33687
Berlin, Germany, 13055
Site Reference ID/Investigator# 33690
Berlin, Germany, 12435
Site Reference ID/Investigator# 33693
Berlin, Germany, 10247
Site Reference ID/Investigator# 33697
Berlin, Germany, 10711
Site Reference ID/Investigator# 33648
Berlin, Germany, 10178
Site Reference ID/Investigator# 34266
Berlin-Buch, Germany, 13125
Site Reference ID/Investigator# 34252
Berlin-Wannsee, Germany, 14109
Site Reference ID/Investigator# 35556
Bernau, Germany, 16321
Site Reference ID/Investigator# 34277
Biberach, Germany, 88400
Site Reference ID/Investigator# 35562
Binzen, Germany, 79589
Site Reference ID/Investigator# 34285
Blankenburg/Hart, Germany, 38889
Site Reference ID/Investigator# 34288
Blaubeuren, Germany, 89143
Site Reference ID/Investigator# 35566
Bocholt, Germany, 46399
Site Reference ID/Investigator# 34291
Bocholt, Germany, 46399
Site Reference ID/Investigator# 35641
Bochum, Germany, 44789
Site Reference ID/Investigator# 35644
Bogen, Germany, 94327
Site Reference ID/Investigator# 34302
Bonn, Germany, 53111
Site Reference ID/Investigator# 35646
Bonn, Germany, 53129
Site Reference ID/Investigator# 34296
Bonn, Germany, 53177
Site Reference ID/Investigator# 35652
Bottrop, Germany, 46242
Site Reference ID/Investigator# 34307
Braunschweig, Germany, 38100
Site Reference ID/Investigator# 35603
Breitenbrunn, Germany, 08359
Site Reference ID/Investigator# 35609
Bremen, Germany, 28209
Site Reference ID/Investigator# 35611
Celle, Germany, 29223
Site Reference ID/Investigator# 35093
Chemnitz, Germany, D-09130
Site Reference ID/Investigator# 34699
Chemnitz, Germany, 09126
Site Reference ID/Investigator# 35615
Coesfeld, Germany, 48653
Site Reference ID/Investigator# 35237
Cologne, Germany, 51067
Site Reference ID/Investigator# 33989
Cologne, Germany, 50823
Site Reference ID/Investigator# 34708
Cottbus, Germany, 03042
Site Reference ID/Investigator# 34711
Cottbus, Germany, 03046
Site Reference ID/Investigator# 35621
Darmstadt, Germany, 64295
Site Reference ID/Investigator# 34725
Deggendorf, Germany, 94469
Site Reference ID/Investigator# 35631
Dessau-Rosslau, Germany, 6842
Site Reference ID/Investigator# 35635
Dortmund, Germany, 44147
Site Reference ID/Investigator# 34742
Dortmund, Germany, 44147
Site Reference ID/Investigator# 35634
Dortmund, Germany, 44263
Site Reference ID/Investigator# 34754
Dresden, Germany, 01109
Site Reference ID/Investigator# 35170
Dresden, Germany, 01097
Site Reference ID/Investigator# 34748
Dresden, Germany, 01277
Site Reference ID/Investigator# 34760
Dresden, Germany, 01277
Site Reference ID/Investigator# 34751
Dresden, Germany, 01277
Site Reference ID/Investigator# 34768
Duesseldorf, Germany, 40217
Site Reference ID/Investigator# 34773
Duesseldorf, Germany, 40211
Site Reference ID/Investigator# 34778
Duisburg, Germany, 47055
Site Reference ID/Investigator# 34784
Eberswalde, Germany, 16225
Site Reference ID/Investigator# 35184
Elmshorn, Germany, 25336
Site Reference ID/Investigator# 35096
Erfurt, Germany, 99096
Site Reference ID/Investigator# 35191
Erfurt, Germany, 99096
Site Reference ID/Investigator# 34809
Erfurt, Germany, 99096
Site Reference ID/Investigator# 34821
Erlangen, Germany, 91056
Site Reference ID/Investigator# 35199
Essen, Germany, 45356
Site Reference ID/Investigator# 35196
Essen, Germany, 45326
Site Reference ID/Investigator# 35202
Feldafing, Germany, 82340
Site Reference ID/Investigator# 35205
Flensburg, Germany, 24937
Site Reference ID/Investigator# 34833
Forchheim, Germany, 91301
Site Reference ID/Investigator# 35210
Frankenberg, Germany, 09669
Site Reference ID/Investigator# 34849
Frankfurt, Germany, 15230
Site Reference ID/Investigator# 34840
Frankfurt, Germany, 60596
Site Reference ID/Investigator# 34843
Frankfurt, Germany, 60596
Site Reference ID/Investigator# 35213
Fraureuth, Germany, 08427
Site Reference ID/Investigator# 35219
Freiberg, Germany, 09599
Site Reference ID/Investigator# 34861
Freiburg, Germany, 79106
Site Reference ID/Investigator# 34854
Freiburg, Germany, 79098
Site Reference ID/Investigator# 35221
Freiburg, Germany, 79104
Site Reference ID/Investigator# 35101
Freystadt, Germany, 92342
Site Reference ID/Investigator# 35224
Friedrichroda, Germany, 99894
Site Reference ID/Investigator# 34879
Gelsenkirchen, Germany, 45881
Site Reference ID/Investigator# 34883
Gera, Germany, 07545
Site Reference ID/Investigator# 34887
Giessen, Germany, 35392
Site Reference ID/Investigator# 35491
Gosheim, Germany, 78559
Site Reference ID/Investigator# 34896
Goslar, Germany, 38642
Site Reference ID/Investigator# 35496
Greifswald, Germany, 17489
Site Reference ID/Investigator# 34901
Greifswald, Germany, 17489
Site Reference ID/Investigator# 34904
Greifswald, Germany, 17491
Site Reference ID/Investigator# 102217
Gross Ammensleben, Germany, 39326
Site Reference ID/Investigator# 35498
Guben, Germany, 3172
Site Reference ID/Investigator# 34912
Guestrow, Germany, 18273
Site Reference ID/Investigator# 35503
Hagen, Germany, 58089
Site Reference ID/Investigator# 34922
Halle, Germany, 06112
Site Reference ID/Investigator# 34940
Halle, Germany, 06108
Site Reference ID/Investigator# 34937
Halle, Germany, 06108
Site Reference ID/Investigator# 34932
Halle, Germany, 06128
Site Reference ID/Investigator# 34944
Halle, Germany, 06120
Site Reference ID/Investigator# 34986
Hamburg, Germany, 22609
Site Reference ID/Investigator# 35449
Hamburg, Germany, 22179
Site Reference ID/Investigator# 34974
Hamburg, Germany, 22767
Site Reference ID/Investigator# 34970
Hamburg, Germany, 20251
Site Reference ID/Investigator# 34961
Hamburg, Germany, 22147
Site Reference ID/Investigator# 34958
Hamburg, Germany, 21075
Site Reference ID/Investigator# 35452
Hamburg, Germany, 22081
Site Reference ID/Investigator# 34952
Hamburg, Germany, 20355
Site Reference ID/Investigator# 35444
Hamburg, Germany, 20144
Site Reference ID/Investigator# 35007
Hamburg, Germany, 22089
Site Reference ID/Investigator# 35000
Hamburg, Germany, 22119
Site Reference ID/Investigator# 34998
Hamburg, Germany, 22459
Site Reference ID/Investigator# 34994
Hamburg, Germany, 22523
Site Reference ID/Investigator# 34983
Hamburg, Germany, 22609
Site Reference ID/Investigator# 34955
Hamburg, Germany, 22415
Site Reference ID/Investigator# 35111
Hamburg, Germany, 22609
Site Reference ID/Investigator# 35441
Hamburg, Germany, 20148
Site Reference ID/Investigator# 35019
Hanau, Germany, 63450
Site Reference ID/Investigator# 33712
Hanover, Germany, 30159
Site Reference ID/Investigator# 35025
Hanover, Germany, 30159
Site Reference ID/Investigator# 33792
Harrislee, Germany, 24955
Site Reference ID/Investigator# 35459
Haseluenne, Germany, 49740
Site Reference ID/Investigator# 102215
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 33808
Heidelberg, Germany, 69121
Site Reference ID/Investigator# 33798
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 33801
Heidelberg, Germany, 69121
Site Reference ID/Investigator# 35119
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 35464
Heidenheim, Germany, 89520
Site Reference ID/Investigator# 33818
Heilbad Heiligenstadt, Germany, 37308
Site Reference ID/Investigator# 33825
Herrsching, Germany, 82211
Site Reference ID/Investigator# 33834
Hof, Germany, 95028
Site Reference ID/Investigator# 33842
Hofheim, Germany, 65719
Site Reference ID/Investigator# 33845
Hohenfelde, Germany, 18209
Site Reference ID/Investigator# 33855
Illertissen, Germany, 89257
Site Reference ID/Investigator# 33858
Immenstadt, Germany, 87509
Site Reference ID/Investigator# 35479
Ingolstadt, Germany, 85049
Site Reference ID/Investigator# 51882
Jena, Germany, 07743
Site Reference ID/Investigator# 33942
Juelich, Germany, 52428
Site Reference ID/Investigator# 33946
Kahla, Germany, 07768
Site Reference ID/Investigator# 35125
Kahla, Germany, 07768
Site Reference ID/Investigator# 33950
Kaiserslautern, Germany, 67655
Site Reference ID/Investigator# 33956
Karlsruhe, Germany, 76133
Site Reference ID/Investigator# 33961
Karlsruhe, Germany, 76133
Site Reference ID/Investigator# 33964
Kassel, Germany, 34131
Site Reference ID/Investigator# 34002
Koenigs Wusterhausen, Germany, 15711
Site Reference ID/Investigator# 34008
Kressbronn, Germany, 88079
Site Reference ID/Investigator# 34084
Kronach, Germany, 96317
Site Reference ID/Investigator# 34005
Lahr, Germany, 77933
Site Reference ID/Investigator# 35245
Landau, Germany, 76829
Site Reference ID/Investigator# 34106
Leipzig, Germany, 04129
Site Reference ID/Investigator# 34109
Leipzig, Germany, 04207
Site Reference ID/Investigator# 34100
Leipzig, Germany, 04299
Site Reference ID/Investigator# 34112
Leipzig, Germany, 04109
Site Reference ID/Investigator# 35254
Lippstadt, Germany, 59555
Site Reference ID/Investigator# 35306
Ludwigsfelde, Germany, 14974
Site Reference ID/Investigator# 35262
Ludwigshafen, Germany, 67069
Site Reference ID/Investigator# 34136
Luebeck, Germany, 23564
Site Reference ID/Investigator# 34139
Lueneburg, Germany, 21335
Site Reference ID/Investigator# 34147
Magdeburg, Germany, 39104
Site Reference ID/Investigator# 34150
Magdeburg, Germany, 39104
Site Reference ID/Investigator# 35276
Mainz, Germany, 55116
Site Reference ID/Investigator# 34192
Marktredwitz, Germany, 95615
Site Reference ID/Investigator# 34196
Marl, Germany, 45768
Site Reference ID/Investigator# 34200
Meissen, Germany, 01662
Site Reference ID/Investigator# 35285
Menz, Germany, 39175
Site Reference ID/Investigator# 35287
Minden, Germany, 32429
Site Reference ID/Investigator# 34208
Mittelherwigsdorf, Germany, 02763
Site Reference ID/Investigator# 34218
Moenchengladbach, Germany, 41061
Site Reference ID/Investigator# 34213
Moenchengladbach, Germany, 41199
Site Reference ID/Investigator# 34221
Moenkeberg, Germany, 24248
Site Reference ID/Investigator# 34224
Muehlhausen, Germany, 99974
Site Reference ID/Investigator# 35292
Muelheim, Germany, 45468
Site Reference ID/Investigator# 34229
Muellheim, Germany, 79379
Site Reference ID/Investigator# 34048
Muenster, Germany, 48149
Site Reference ID/Investigator# 34043
Munich, Germany, 81925
Site Reference ID/Investigator# 34040
Munich, Germany, 80639
Site Reference ID/Investigator# 34232
Munich, Germany, 81547
Site Reference ID/Investigator# 35295
Munich, Germany, 81377
Site Reference ID/Investigator# 34235
Munich, Germany, 81547
Site Reference ID/Investigator# 35298
Munich, Germany, 81667
Site Reference ID/Investigator# 34052
Naunhof, Germany, 04683
Site Reference ID/Investigator# 34061
Neubrandenburg, Germany, 17033
Site Reference ID/Investigator# 34064
Neuburg, Germany, 86633
Site Reference ID/Investigator# 34071
Neumuenster, Germany, 24534
Site Reference ID/Investigator# 35313
Neuss, Germany, 41460
Site Reference ID/Investigator# 34076
Neustadt, Germany, 67434
Site Reference ID/Investigator# 35321
Niederbrombach, Germany, 55767
Site Reference ID/Investigator# 34080
Niefern-Oeschelbronn, Germany, 75223
Site Reference ID/Investigator# 34158
Nienburg, Germany, 31582
Site Reference ID/Investigator# 34173
Oelsnitz, Germany, 09376
Site Reference ID/Investigator# 34176
Offenburg, Germany, 77652
Site Reference ID/Investigator# 33492
Oldenburg, Germany, 26121
Site Reference ID/Investigator# 34718
Ostseebad Damp, Germany, 24351
Site Reference ID/Investigator# 35335
Paderborn, Germany, 33098
Site Reference ID/Investigator# 33508
Parchim, Germany, 19370
Site Reference ID/Investigator# 35340
Passau, Germany, 94032
Site Reference ID/Investigator# 33517
Pfullendorf, Germany, 88630
Site Reference ID/Investigator# 67482
Pirna, Germany, 01796
Site Reference ID/Investigator# 33523
Planegg, Germany, 82152
Site Reference ID/Investigator# 33528
Plauen, Germany, 08523
Site Reference ID/Investigator# 33466
Potsdam, Germany, 14469
Site Reference ID/Investigator# 33470
Potsdam, Germany, 14467
Site Reference ID/Investigator# 33476
Pruem, Germany, 54595
Site Reference ID/Investigator# 33479
Puettlingen, Germany, 66346
Site Reference ID/Investigator# 35347
Radebeul, Germany, 01445
Site Reference ID/Investigator# 33484
Radebeul, Germany, 01445
Site Reference ID/Investigator# 35136
Ratingen, Germany, 40882
Site Reference ID/Investigator# 33488
Ratzeburg, Germany, 23909
Site Reference ID/Investigator# 33890
Regensburg, Germany, 93049
Site Reference ID/Investigator# 33886
Regensburg, Germany, 93051
Site Reference ID/Investigator# 33883
Regensburg, Germany, 93051
Site Reference ID/Investigator# 33897
Reken, Germany, 48734
Site Reference ID/Investigator# 33902
Rendsburg, Germany, 24768
Site Reference ID/Investigator# 33907
Rheine, Germany, 48431
Site Reference ID/Investigator# 35355
Rickenbach, Germany, 79736
Site Reference ID/Investigator# 33911
Riesa, Germany, 01589
Site Reference ID/Investigator# 33914
Rinteln, Germany, 31737
Site Reference ID/Investigator# 33927
Rostock, Germany, 18059
Site Reference ID/Investigator# 33923
Rostock, Germany, 18059
Site Reference ID/Investigator# 33931
Rothenburg, Germany, 02929
Site Reference ID/Investigator# 35362
Ruedersdorf, Germany, 15562
Site Reference ID/Investigator# 34016
Saarbruecken, Germany, 66111
Site Reference ID/Investigator# 34023
Salzwedel, Germany, 29410
Site Reference ID/Investigator# 34027
Sande, Germany, 26452
Site Reference ID/Investigator# 33534
Schneeberg, Germany, 08289
Site Reference ID/Investigator# 33539
Schramberg, Germany, 78713
Site Reference ID/Investigator# 33542
Schutterwald, Germany, 77746
Site Reference ID/Investigator# 35371
Schwandorf, Germany, 92421
Site Reference ID/Investigator# 33549
Schwerin, Germany, 19053
Site Reference ID/Investigator# 35376
Schwerin, Germany, 19053
Site Reference ID/Investigator# 33555
Schwerte, Germany, 58239
Site Reference ID/Investigator# 33559
Seesen, Germany, 38723
Site Reference ID/Investigator# 33563
Senden, Germany, 48308
Site Reference ID/Investigator# 35380
Singen, Germany, 78224
Site Reference ID/Investigator# 33567
Sinsheim, Germany, 74889
Site Reference ID/Investigator# 33572
Soltau, Germany, 29614
Site Reference ID/Investigator# 33577
Spremberg, Germany, 03130
Site Reference ID/Investigator# 35383
St. Martin, Germany, 67487
Site Reference ID/Investigator# 33588
Stadthagen, Germany, 31655
Site Reference ID/Investigator# 33592
Steinhagen, Germany, 33803
Site Reference ID/Investigator# 33607
Stuttgart, Germany, 70178
Site Reference ID/Investigator# 33598
Stuttgart, Germany, 70372
Site Reference ID/Investigator# 33611
Stuttgart, Germany, 70199
Site Reference ID/Investigator# 33604
Stuttgart, Germany, 70178
Site Reference ID/Investigator# 35389
Suhl, Germany, 98529
Site Reference ID/Investigator# 35391
Tegernau, Germany, 79692
Site Reference ID/Investigator# 33625
Torgelow, Germany, 17358
Site Reference ID/Investigator# 33637
Ueberlingen-Nussdorf, Germany, 88662
Site Reference ID/Investigator# 35395
Uffenheim, Germany, 97215
Site Reference ID/Investigator# 33721
Ulm, Germany, 89073
Site Reference ID/Investigator# 33724
Ulm, Germany, 89073
Site Reference ID/Investigator# 33734
Viersen, Germany, 41747
Site Reference ID/Investigator# 33737
Villingen-Schwenningen, Germany, 78054
Site Reference ID/Investigator# 35397
Voehringen, Germany, 72189
Site Reference ID/Investigator# 33742
Waltrop, Germany, 45731
Site Reference ID/Investigator# 33749
Weener, Germany, 26826
Site Reference ID/Investigator# 33751
Weissenfels, Germany, 06667
Site Reference ID/Investigator# 33852
Welzow, Germany, 03119
Site Reference ID/Investigator# 35404
Wiefelstede, Germany, 26215
Site Reference ID/Investigator# 33765
Wiesbaden, Germany, 65191
Site Reference ID/Investigator# 35413
Wiesbaden, Germany, 65191
Site Reference ID/Investigator# 35408
Wiesbaden, Germany, 65189
Site Reference ID/Investigator# 33761
Wiesbaden, Germany, 65189
Site Reference ID/Investigator# 33772
Wilhelmshaven, Germany, 26382
Site Reference ID/Investigator# 33780
Wittlich, Germany, 54516
Site Reference ID/Investigator# 33718
Wuerzburg, Germany, 97070
Site Reference ID/Investigator# 35420
Wuppertal, Germany, 42105
Site Reference ID/Investigator# 33864
Zerbst, Germany, 39261
Site Reference ID/Investigator# 33867
Zeven, Germany, 27404
Site Reference ID/Investigator# 33876
Zwickau, Germany, 08060
Site Reference ID/Investigator# 33873
Zwickau, Germany, 08056
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
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01077258     History of Changes
Other Study ID Numbers: P10-448
Study First Received: February 25, 2010
Results First Received: February 28, 2014
Last Updated: April 9, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Safety
Long-term observation
Routine Clinical Setting
Rheumatoid Arthritis
Effectiveness

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014