Clinical trial NCT01078090: Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice
Official title: Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Safety
Rheumatoid Arthritis
Effectiveness
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 5745
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population: 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.

Brief summary: Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.

Detailed description: Patients with Rheumatoid Arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. The follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the 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 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, adalimumab 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

Primary outcomes:
measure: Change From Baseline in Disease Activity Score (DAS) 28
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Percentage of Participants in DAS28 Remission
timeFrame: Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Secondary outcomes:
measure: Percentage of Participants With a Significant Therapeutic Response
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Percentage of Participants With Low, Moderate and High Disease Activity
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Erythrocyte Sedimentation Rate (ESR) Over Time
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: C-Reactive Protein (CRP) Levels Over Time
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Tender Joint Count (TJC) Over Time
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Swollen Joint Count (SJC) Over Time
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Hannover Functional Questionnaire (FFbH) Over Time
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Patients Global Assessment of Disease Activity Over Time
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Participants Assessment of Pain Over Time
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Participants Assessment of Fatigue Over Time
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
measure: Percentage of Participants With Impairment in Daily Activities
timeFrame: Baseline and Months 6, 18, 24, and 30
measure: Number of Days Missed From Work Due to Rheumatoid Arthritis
timeFrame: Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60
measure: Percentage of Participants With In-patient Hospitalization
timeFrame: Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60
measure: Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
timeFrame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Site Reference ID/Investigator# 35034
city: Aachen
country: Germany
facility: Site Reference ID/Investigator# 35033
city: Achern
country: Germany
facility: Site Reference ID/Investigator# 53919
city: Aichhalden
country: Germany
facility: Site Reference ID/Investigator# 53883
city: Altenburg
country: Germany
facility: Site Reference ID/Investigator# 35041
city: Amberg
country: Germany
facility: Site Reference ID/Investigator# 35050
city: Amberg
country: Germany
facility: Site Reference ID/Investigator# 53974
city: Augsburg
country: Germany
facility: Site Reference ID/Investigator# 33347
city: Bad Abbach
country: Germany
facility: Site Reference ID/Investigator# 33356
city: Bad Abbach
country: Germany
facility: Site Reference ID/Investigator# 33359
city: Bad Aibling
country: Germany
facility: Site Reference ID/Investigator# 33362
city: Bad Aibling
country: Germany
facility: Site Reference ID/Investigator# 35084
city: Bad Aibling
country: Germany
facility: Site Reference ID/Investigator# 53968
city: Bad Bellingen
country: Germany
facility: Site Reference ID/Investigator# 53966
city: Bad Bentheim
country: Germany
facility: Site Reference ID/Investigator# 35523
city: Bad Bramstedt
country: Germany
facility: Site Reference ID/Investigator# 35571
city: Bad Bramstedt
country: Germany
facility: Site Reference ID/Investigator# 53903
city: Bad Buchau
country: Germany
facility: Site Reference ID/Investigator# 53929
city: Bad Endbach
country: Germany
facility: Site Reference ID/Investigator# 33370
city: Bad Endbach
country: Germany
facility: Site Reference ID/Investigator# 33369
city: Bad Iburg
country: Germany
facility: Site Reference ID/Investigator# 33380
city: Bad Kissingen
country: Germany
facility: Site Reference ID/Investigator# 33384
city: Bad Kreuznach
country: Germany
facility: Site Reference ID/Investigator# 33385
city: Bad Liebenwerda
country: Germany
facility: Site Reference ID/Investigator# 33389
city: Bad Mergentheim
country: Germany
facility: Site Reference ID/Investigator# 53942
city: Bad Muender
country: Germany
facility: Site Reference ID/Investigator# 33394
city: Bad Nauheim
country: Germany
facility: Site Reference ID/Investigator# 33398
city: Bad Neuenahr
country: Germany
facility: Site Reference ID/Investigator# 33399
city: Bad Neuenahr
country: Germany
facility: Site Reference ID/Investigator# 35576
city: Bad Pyrmont
country: Germany
facility: Site Reference ID/Investigator# 53980
city: Bad Rappenau
country: Germany
facility: Site Reference ID/Investigator# 33402
city: Bad Soden-Salmuenster
country: Germany
facility: Site Reference ID/Investigator# 33410
city: Bad Staffelstein
country: Germany
facility: Site Reference ID/Investigator# 33415
city: Bad Toelz
country: Germany
facility: Site Reference ID/Investigator# 54804
city: Baden-Baden
country: Germany
facility: Site Reference ID/Investigator# 33423
city: Bamberg
country: Germany
facility: Site Reference ID/Investigator# 33427
city: Bautzen
country: Germany
facility: Site Reference ID/Investigator# 33436
city: Bayreuth
country: Germany
facility: Site Reference ID/Investigator# 33440
city: Belm
country: Germany
facility: Site Reference ID/Investigator# 53978
city: Bensheim
country: Germany
facility: Site Reference ID/Investigator# 33449
city: Berlin-Buch
country: Germany
facility: Site Reference ID/Investigator# 34264
city: Berlin-Wannsee
country: Germany
facility: Site Reference ID/Investigator# 34250
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 33646
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 53902
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 33662
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 33695
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 34243
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 33681
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 35599
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 53959
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 33688
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 34260
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 33685
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 53948
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 53939
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 53971
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 53933
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 53884
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 33672
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 35552
city: Bernau
country: Germany
facility: Site Reference ID/Investigator# 35554
city: Biberach
country: Germany
facility: Site Reference ID/Investigator# 53899
city: Bielefeld
country: Germany
facility: Site Reference ID/Investigator# 34279
city: Bielefeld
country: Germany
facility: Site Reference ID/Investigator# 54810
city: Bietigheim-Bissingen
country: Germany
facility: Site Reference ID/Investigator# 35559
city: Bietigheim-Bissingen
country: Germany
facility: Site Reference ID/Investigator# 35560
city: Blankenburg/Hart
country: Germany
facility: Site Reference ID/Investigator# 34283
city: Blaubeuren
country: Germany
facility: Site Reference ID/Investigator# 34286
city: Bocholt
country: Germany
facility: Site Reference ID/Investigator# 34289
city: Bocholt
country: Germany
facility: Site Reference ID/Investigator# 53946
city: Bochum
country: Germany
facility: Site Reference ID/Investigator# 35567
city: Bogen
country: Germany
facility: Site Reference ID/Investigator# 35642
city: Bonn
country: Germany
facility: Site Reference ID/Investigator# 34300
city: Bonn
country: Germany
facility: Site Reference ID/Investigator# 53969
city: Bonn
country: Germany
facility: Site Reference ID/Investigator# 35647
city: Bonn
country: Germany
facility: Site Reference ID/Investigator# 35648
city: Bonn
country: Germany
facility: Site Reference ID/Investigator# 34294
city: Braunschweig
country: Germany
facility: Site Reference ID/Investigator# 34305
city: Braunschweig
country: Germany
facility: Site Reference ID/Investigator# 34310
city: Breitenbrunn
country: Germany
facility: Site Reference ID/Investigator# 35601
city: Bremen
country: Germany
facility: Site Reference ID/Investigator# 35607
city: Bremen
country: Germany
facility: Site Reference ID/Investigator# 53975
city: Buechen
country: Germany
facility: Site Reference ID/Investigator# 53934
city: Celle
country: Germany
facility: Site Reference ID/Investigator# 34696
city: Chemnitz
country: Germany
facility: Site Reference ID/Investigator# 34700
city: Chemnitz
country: Germany
facility: Site Reference ID/Investigator# 35092
city: Cologne
country: Germany
facility: Site Reference ID/Investigator# 33990
city: Cologne
country: Germany
facility: Site Reference ID/Investigator# 33987
city: Cologne
country: Germany
facility: Site Reference ID/Investigator# 33996
city: Cologne
country: Germany
facility: Site Reference ID/Investigator# 33993
city: Cologne
country: Germany
facility: Site Reference ID/Investigator# 35238
city: Cottbus
country: Germany
facility: Site Reference ID/Investigator# 35617
city: Cuxhaven
country: Germany
facility: Site Reference ID/Investigator# 53987
city: Cuxhaven
country: Germany
facility: Site Reference ID/Investigator# 53889
city: Darmstadt
country: Germany
facility: Site Reference ID/Investigator# 35622
city: Delmenhorst
country: Germany
facility: Site Reference ID/Investigator# 53885
city: Demmin
country: Germany
facility: Site Reference ID/Investigator# 34726
city: Denkendorf
country: Germany
facility: Site Reference ID/Investigator# 53932
city: Dortmund
country: Germany
facility: Site Reference ID/Investigator# 35636
city: Dortmund
country: Germany
facility: Site Reference ID/Investigator# 35632
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 35171
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 34762
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 53958
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 34749
city: Dresden
country: Germany
facility: Site Reference ID/Investigator# 34763
city: Duesseldorf
country: Germany
facility: Site Reference ID/Investigator# 34771
city: Duesseldorf
country: Germany
facility: Site Reference ID/Investigator# 34774
city: Duisburg
country: Germany
facility: Site Reference ID/Investigator# 34776
city: Duisburg
country: Germany
facility: Site Reference ID/Investigator# 53897
city: Ebensfeld
country: Germany
facility: Site Reference ID/Investigator# 34779
city: Eberswalde
country: Germany
facility: Site Reference ID/Investigator# 34782
city: Eisenberg
country: Germany
facility: Site Reference ID/Investigator# 54805
city: Elmshorn
country: Germany
facility: Site Reference ID/Investigator# 35180
city: Erftstadt
country: Germany
facility: Site Reference ID/Investigator# 34802
city: Erfurt
country: Germany
facility: Site Reference ID/Investigator# 34807
city: Erfurt
country: Germany
facility: Site Reference ID/Investigator# 35097
city: Erfurt
country: Germany
facility: Site Reference ID/Investigator# 35189
city: Erlangen
country: Germany
facility: Site Reference ID/Investigator# 54811
city: Erlangen
country: Germany
facility: Site Reference ID/Investigator# 34815
city: Essen
country: Germany
facility: Site Reference ID/Investigator# 53925
city: Essen
country: Germany
facility: Site Reference ID/Investigator# 34823
city: Essen
country: Germany
facility: Site Reference ID/Investigator# 35194
city: Essen
country: Germany
facility: Site Reference ID/Investigator# 53931
city: Essen
country: Germany
facility: Site Reference ID/Investigator# 53945
city: Esslingen
country: Germany
facility: Site Reference ID/Investigator# 34829
city: Feldafing
country: Germany
facility: Site Reference ID/Investigator# 35200
city: Flensburg
country: Germany
facility: Site Reference ID/Investigator# 35203
city: Forchheim
country: Germany
facility: Site Reference ID/Investigator# 34831
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 34851
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 34838
city: Fraureuth
country: Germany
facility: Site Reference ID/Investigator# 35211
city: Freiberg
country: Germany
facility: Site Reference ID/Investigator# 35217
city: Freiburg
country: Germany
facility: Site Reference ID/Investigator# 34852
city: Freiburg
country: Germany
facility: Site Reference ID/Investigator# 34855
city: Freiburg
country: Germany
facility: Site Reference ID/Investigator# 53926
city: Freiburg
country: Germany
facility: Site Reference ID/Investigator# 34859
city: Freystadt
country: Germany
facility: Site Reference ID/Investigator# 35099
city: Friedberg
country: Germany
facility: Site Reference ID/Investigator# 53960
city: Friedrichroda
country: Germany
facility: Site Reference ID/Investigator# 35222
city: Geesthacht
country: Germany
facility: Site Reference ID/Investigator# 53976
city: Geilenkirchen
country: Germany
facility: Site Reference ID/Investigator# 53890
city: Gelsenkirchen
country: Germany
facility: Site Reference ID/Investigator# 34877
city: Giessen
country: Germany
facility: Site Reference ID/Investigator# 53909
city: Gladbeck
country: Germany
facility: Site Reference ID/Investigator# 53922
city: Goettingen
country: Germany
facility: Site Reference ID/Investigator# 35231
city: Goettingen
country: Germany
facility: Site Reference ID/Investigator# 65622
city: Goslar
country: Germany
facility: Site Reference ID/Investigator# 34894
city: Greifswald
country: Germany
facility: Site Reference ID/Investigator# 34902
city: Guestrow
country: Germany
facility: Site Reference ID/Investigator# 34910
city: Hagen
country: Germany
facility: Site Reference ID/Investigator# 35501
city: Halle
country: Germany
facility: Site Reference ID/Investigator# 34924
city: Halle
country: Germany
facility: Site Reference ID/Investigator# 34935
city: Halle
country: Germany
facility: Site Reference ID/Investigator# 34938
city: Halle
country: Germany
facility: Site Reference ID/Investigator# 34920
city: Halle
country: Germany
facility: Site Reference ID/Investigator# 34942
city: Halle
country: Germany
facility: Site Reference ID/Investigator# 33819
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 35442
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 53984
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 33367
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 53900
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34956
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34962
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 35450
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 35112
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34946
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 35001
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34959
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34977
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34965
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 54806
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 33578
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34967
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34989
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34981
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34984
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 34996
city: Hamm
country: Germany
facility: Site Reference ID/Investigator# 53953
city: Hanau
country: Germany
facility: Site Reference ID/Investigator# 35017
city: Hannover
country: Germany
facility: Site Reference ID/Investigator# 33788
city: Hanover
country: Germany
facility: Site Reference ID/Investigator# 33713
city: Hanover
country: Germany
facility: Site Reference ID/Investigator# 35032
city: Hanover
country: Germany
facility: Site Reference ID/Investigator# 35021
city: Harrislee
country: Germany
facility: Site Reference ID/Investigator# 33790
city: Haseluenne
country: Germany
facility: Site Reference ID/Investigator# 65629
city: Hattingen
country: Germany
facility: Site Reference ID/Investigator# 33795
city: Heidelberg
country: Germany
facility: Site Reference ID/Investigator# 33796
city: Heidelberg
country: Germany
facility: Site Reference ID/Investigator# 33806
city: Heidelberg
country: Germany
facility: Site Reference ID/Investigator# 33811
city: Heilbad Heiligenstadt
country: Germany
facility: Site Reference ID/Investigator# 33816
city: Herne
country: Germany
facility: Site Reference ID/Investigator# 53911
city: Herne
country: Germany
facility: Site Reference ID/Investigator# 53910
city: Herne
country: Germany
facility: Site Reference ID/Investigator# 65623
city: Herrsching
country: Germany
facility: Site Reference ID/Investigator# 33823
city: Hildesheim
country: Germany
facility: Site Reference ID/Investigator# 33831
city: Hofheim
country: Germany
facility: Site Reference ID/Investigator# 33840
city: Hof
country: Germany
facility: Site Reference ID/Investigator# 33836
city: Hohenfelde
country: Germany
facility: Site Reference ID/Investigator# 33843
city: Homburg
country: Germany
facility: Site Reference ID/Investigator# 54807
city: Illingen
country: Germany
facility: Site Reference ID/Investigator# 53985
city: Ingolstadt
country: Germany
facility: Site Reference ID/Investigator# 33933
city: Jena
country: Germany
facility: Site Reference ID/Investigator# 53938
city: Jena
country: Germany
facility: Site Reference ID/Investigator# 5323
city: Juelich
country: Germany
facility: Site Reference ID/Investigator# 33940
city: Kahla
country: Germany
facility: Site Reference ID/Investigator# 33944
city: Kahla
country: Germany
facility: Site Reference ID/Investigator# 35124
city: Kaiserslautern
country: Germany
facility: Site Reference ID/Investigator# 33948
city: Kaltenkirchen
country: Germany
facility: Site Reference ID/Investigator# 53935
city: Karlsruhe
country: Germany
facility: Site Reference ID/Investigator# 33397
city: Karlsruhe
country: Germany
facility: Site Reference ID/Investigator# 33954
city: Karlstadt
country: Germany
facility: Site Reference ID/Investigator# 35482
city: Kassel
country: Germany
facility: Site Reference ID/Investigator# 33962
city: Koenigs Wusterhausen
country: Germany
facility: Site Reference ID/Investigator# 34000
city: Kolkwitz
country: Germany
facility: Site Reference ID/Investigator# 35239
city: Kressbronn
country: Germany
facility: Site Reference ID/Investigator# 34006
city: Kronach
country: Germany
facility: Site Reference ID/Investigator# 34009
city: Kyritz
country: Germany
facility: Site Reference ID/Investigator# 34086
city: Lahr
country: Germany
facility: Site Reference ID/Investigator# 34003
city: Leipzig
country: Germany
facility: Site Reference ID/Investigator# 53937
city: Leipzig
country: Germany
facility: Site Reference ID/Investigator# 65628
city: Leipzig
country: Germany
facility: Site Reference ID/Investigator# 34107
city: Leipzig
country: Germany
facility: Site Reference ID/Investigator# 34098
city: Leverkusen
country: Germany
facility: Site Reference ID/Investigator# 34119
city: Lichtenstein
country: Germany
facility: Site Reference ID/Investigator# 34121
city: Lippstadt
country: Germany
facility: Site Reference ID/Investigator# 35252
city: Lohne
country: Germany
facility: Site Reference ID/Investigator# 53882
city: Ludwigsburg
country: Germany
facility: Site Reference ID/Investigator# 53886
city: Ludwigsfelde
country: Germany
facility: Site Reference ID/Investigator# 35257
city: Ludwigslust
country: Germany
facility: Site Reference ID/Investigator# 53906
city: Luebeck
country: Germany
facility: Site Reference ID/Investigator# 34133
city: Luedenscheid
country: Germany
facility: Site Reference ID/Investigator# 53943
city: Lueneburg
country: Germany
facility: Site Reference ID/Investigator# 33407
city: Lueneburg
country: Germany
facility: Site Reference ID/Investigator# 53888
city: Magdeburg
country: Germany
facility: Site Reference ID/Investigator# 34148
city: Magdeburg
country: Germany
facility: Site Reference ID/Investigator# 53981
city: Magdeburg
country: Germany
facility: Site Reference ID/Investigator# 53913
city: Mainz
country: Germany
facility: Site Reference ID/Investigator# 53928
city: Mainz
country: Germany
facility: Site Reference ID/Investigator# 65631
city: Mannheim
country: Germany
facility: Site Reference ID/Investigator# 34184
city: Marl
country: Germany
facility: Site Reference ID/Investigator# 34194
city: Menz
country: Germany
facility: Site Reference ID/Investigator# 35283
city: Merxheim
country: Germany
facility: Site Reference ID/Investigator# 53896
city: Minden
country: Germany
facility: Site Reference ID/Investigator# 33418
city: Mittelherwigsdorf
country: Germany
facility: Site Reference ID/Investigator# 34206
city: Moenchengladbach
country: Germany
facility: Site Reference ID/Investigator# 34216
city: Moenchengladbach
country: Germany
facility: Site Reference ID/Investigator# 53915
city: Moenchengladbach
country: Germany
facility: Site Reference ID/Investigator# 34211
city: Moenchengladbach
country: Germany
facility: Site Reference ID/Investigator# 34214
city: Moenkeberg
country: Germany
facility: Site Reference ID/Investigator# 34219
city: Muehlhausen
country: Germany
facility: Site Reference ID/Investigator# 34222
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 34044
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 53970
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 34046
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 53904
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 53956
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 34037
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 53962
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 53912
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 35296
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 53924
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 34041
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 34035
city: Naunhof
country: Germany
facility: Site Reference ID/Investigator# 34050
city: Neubrandenburg
country: Germany
facility: Site Reference ID/Investigator# 34059
city: Neuburg
country: Germany
facility: Site Reference ID/Investigator# 34062
city: Neunkirchen
country: Germany
facility: Site Reference ID/Investigator# 34980
city: Neuss
country: Germany
facility: Site Reference ID/Investigator# 35311
city: Neustadt
country: Germany
facility: Site Reference ID/Investigator# 34072
city: Neuwied
country: Germany
facility: Site Reference ID/Investigator# 65630
city: Niederbrombach
country: Germany
facility: Site Reference ID/Investigator# 82694
city: Niefern-Oeschelbronn
country: Germany
facility: Site Reference ID/Investigator# 34078
city: Nienburg
country: Germany
facility: Site Reference ID/Investigator# 34081
city: Nienburg
country: Germany
facility: Site Reference ID/Investigator# 34082
city: Nuremberg
country: Germany
facility: Site Reference ID/Investigator# 53923
city: Oberguenzburg
country: Germany
facility: Site Reference ID/Investigator# 34168
city: Offenburg
country: Germany
facility: Site Reference ID/Investigator# 34174
city: Oldenburg
country: Germany
facility: Site Reference ID/Investigator# 33490
city: Olsberg
country: Germany
facility: Site Reference ID/Investigator# 53950
city: Osnabrueck
country: Germany
facility: Site Reference ID/Investigator# 33499
city: Osnabrueck
country: Germany
facility: Site Reference ID/Investigator# 54803
city: Ostseebad Damp
country: Germany
facility: Site Reference ID/Investigator# 34715
city: Paderborn
country: Germany
facility: Site Reference ID/Investigator# 35333
city: Papenburg
country: Germany
facility: Site Reference ID/Investigator# 33503
city: Parchim
country: Germany
facility: Site Reference ID/Investigator# 33506
city: Parsberg
country: Germany
facility: Site Reference ID/Investigator# 33509
city: Passau
country: Germany
facility: Site Reference ID/Investigator# 35338
city: Petershagen
country: Germany
facility: Site Reference ID/Investigator# 33511
city: Pinneberg
country: Germany
facility: Site Reference ID/Investigator# 33519
city: Pirna
country: Germany
facility: Site Reference ID/Investigator# 33520
city: Planegg
country: Germany
facility: Site Reference ID/Investigator# 33521
city: Plauen
country: Germany
facility: Site Reference ID/Investigator# 33526
city: Potsdam
country: Germany
facility: Site Reference ID/Investigator# 33468
city: Potsdam
country: Germany
facility: Site Reference ID/Investigator# 33464
city: Pulheim
country: Germany
facility: Site Reference ID/Investigator# 53940
city: Radebeul
country: Germany
facility: Site Reference ID/Investigator# 33482
city: Raststatt
country: Germany
facility: Site Reference ID/Investigator# 53964
city: Ratingen
country: Germany
facility: Site Reference ID/Investigator# 33485
city: Ratingen
country: Germany
facility: Site Reference ID/Investigator# 35134
city: Ratingen
country: Germany
facility: Site Reference ID/Investigator# 54812
city: Regensburg
country: Germany
facility: Site Reference ID/Investigator# 33888
city: Regensburg
country: Germany
facility: Site Reference ID/Investigator# 33891
city: Regensburg
country: Germany
facility: Site Reference ID/Investigator# 33881
city: Regensburg
country: Germany
facility: Site Reference ID/Investigator# 33884
city: Regensburg
country: Germany
facility: Site Reference ID/Investigator# 53930
city: Reichenbach
country: Germany
facility: Site Reference ID/Investigator# 53986
city: Reken
country: Germany
facility: Site Reference ID/Investigator# 53957
city: Remscheid
country: Germany
facility: Site Reference ID/Investigator# 53920
city: Rendsburg
country: Germany
facility: Site Reference ID/Investigator# 33900
city: Reutlingen
country: Germany
facility: Site Reference ID/Investigator# 33903
city: Rheinfelden
country: Germany
facility: Site Reference ID/Investigator# 53982
city: Rickenbach
country: Germany
facility: Site Reference ID/Investigator# 53908
city: Riesa
country: Germany
facility: Site Reference ID/Investigator# 33393
city: Rinteln
country: Germany
facility: Site Reference ID/Investigator# 33912
city: Rostock
country: Germany
facility: Site Reference ID/Investigator# 33921
city: Rothenburg
country: Germany
facility: Site Reference ID/Investigator# 33929
city: Saarbruecken
country: Germany
facility: Site Reference ID/Investigator# 34014
city: Salzwedel
country: Germany
facility: Site Reference ID/Investigator# 34021
city: Schlangenbad
country: Germany
facility: Site Reference ID/Investigator# 53916
city: Schneeberg
country: Germany
facility: Site Reference ID/Investigator# 34030
city: Schwerin
country: Germany
facility: Site Reference ID/Investigator# 33550
city: Schwerin
country: Germany
facility: Site Reference ID/Investigator# 35374
city: Schwerte
country: Germany
facility: Site Reference ID/Investigator# 33553
city: Seesen
country: Germany
facility: Site Reference ID/Investigator# 33557
city: Siegen
country: Germany
facility: Site Reference ID/Investigator# 53944
city: Sinsheim
country: Germany
facility: Site Reference ID/Investigator# 33565
city: Solingen
country: Germany
facility: Site Reference ID/Investigator# 53927
city: Soltau
country: Germany
facility: Site Reference ID/Investigator# 33570
city: Stadtbergen
country: Germany
facility: Site Reference ID/Investigator# 33583
city: Stadthagen
country: Germany
facility: Site Reference ID/Investigator# 33586
city: Steinhagen
country: Germany
facility: Site Reference ID/Investigator# 53936
city: Stuttgart
country: Germany
facility: Site Reference ID/Investigator# 33602
city: Stuttgart
country: Germany
facility: Site Reference ID/Investigator# 33609
city: Stuttgart
country: Germany
facility: Site Reference ID/Investigator# 33596
city: Suhl
country: Germany
facility: Site Reference ID/Investigator# 35387
city: Tarp
country: Germany
facility: Site Reference ID/Investigator# 54808
city: Thum-Jahnsbach
country: Germany
facility: Site Reference ID/Investigator# 35433
city: Tischenreuth
country: Germany
facility: Site Reference ID/Investigator# 53951
city: Torgelow
country: Germany
facility: Site Reference ID/Investigator# 33623
city: Treuenbrietzen
country: Germany
facility: Site Reference ID/Investigator# 33628
city: Tuebingen
country: Germany
facility: Site Reference ID/Investigator# 53907
city: Twistringen
country: Germany
facility: Site Reference ID/Investigator# 53893
city: Ueberlingen-Nussdorf
country: Germany
facility: Site Reference ID/Investigator# 33635
city: Uhlstaedt-Kirchhasel
country: Germany
facility: Site Reference ID/Investigator# 53898
city: Ulm
country: Germany
facility: Site Reference ID/Investigator# 33722
city: Ulm
country: Germany
facility: Site Reference ID/Investigator# 65626
city: Verden
country: Germany
facility: Site Reference ID/Investigator# 33732
city: Viersen
country: Germany
facility: Site Reference ID/Investigator# 53965
city: Villingen-Schwenningen
country: Germany
facility: Site Reference ID/Investigator# 33735
city: Vogelsang-Gommern
country: Germany
facility: Site Reference ID/Investigator# 53914
city: Vreden
country: Germany
facility: Site Reference ID/Investigator# 53952
city: Waldbronn
country: Germany
facility: Site Reference ID/Investigator# 54809
city: Waltrop
country: Germany
facility: Site Reference ID/Investigator# 33740
city: Weener
country: Germany
facility: Site Reference ID/Investigator# 33747
city: Weiden i.d. Oberpfalz
country: Germany
facility: Site Reference ID/Investigator# 53891
city: Weissenfels
country: Germany
facility: Site Reference ID/Investigator# 53921
city: Welzow
country: Germany
facility: Site Reference ID/Investigator# 33753
city: Wiesbaden
country: Germany
facility: Site Reference ID/Investigator# 35406
city: Wiesbaden
country: Germany
facility: Site Reference ID/Investigator# 53941
city: Wiesbaden
country: Germany
facility: Site Reference ID/Investigator# 33762
city: Wilhelmshaven
country: Germany
facility: Site Reference ID/Investigator# 33770
city: Winsen (Luhe)
country: Germany
facility: Site Reference ID/Investigator# 53977
city: Winsen
country: Germany
facility: Site Reference ID/Investigator# 53954
city: Wittlich
country: Germany
facility: Site Reference ID/Investigator# 33778
city: Wolfsburg
country: Germany
facility: Site Reference ID/Investigator# 33783
city: Wuerzburg
country: Germany
facility: Site Reference ID/Investigator# 33716
city: Wuppertal
country: Germany
facility: Site Reference ID/Investigator# 53917
city: Wuppertal
country: Germany
facility: Site Reference ID/Investigator# 35418
city: Zerbst
country: Germany
facility: Site Reference ID/Investigator# 33862
city: Zeven
country: Germany
facility: Site Reference ID/Investigator# 33865
city: Zwickau
country: Germany
facility: Site Reference ID/Investigator# 33870
city: Zwiesel
country: Germany
facility: Site Reference ID/Investigator# 33878
Study officials:
affiliation: AbbVie Deutschland GmbH & Co. KG, Medical Department
name: Bianca Wittig, MD
role: STUDY_DIRECTOR
References:
citation: Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Wittig BM, Gnann H, Greger G, Tony HP, Burkhardt H. Addition or removal of concomitant methotrexate alters adalimumab effectiveness in rheumatoid arthritis but not psoriatic arthritis. Scand J Rheumatol. 2019 Sep;48(5):375-382. doi: 10.1080/03009742.2019.1600717. Epub 2019 Jul 16.
citation: Scharbatke EC, Behrens F, Schmalzing M, Koehm M, Greger G, Gnann H, Burkhardt H, Tony HP. Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1607-1615. doi: 10.1002/acr.22884. Epub 2016 Oct 1.