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

NCT ID: NCT01077258

Last Updated: 2014-04-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Rheumatoid arthritis

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bianca Wittig, MD

Role: STUDY_DIRECTOR

AbbVie Deutschland GmbH & Co. KG, Medical Department

Locations

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Site Reference ID/Investigator# 35036

Aachen, , Germany

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Site Reference ID/Investigator# 35510

Ahlen, , Germany

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Site Reference ID/Investigator# 35040

Ahrensburg, , Germany

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Site Reference ID/Investigator# 35043

Altenburg, , Germany

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Site Reference ID/Investigator# 35046

Altenholz, , Germany

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Site Reference ID/Investigator# 35049

Amberg, , Germany

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Site Reference ID/Investigator# 35057

Arnstadt, , Germany

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Site Reference ID/Investigator# 35520

Attendorn, , Germany

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Site Reference ID/Investigator# 33349

Augsburg, , Germany

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Site Reference ID/Investigator# 33358

Bad Abbach, , Germany

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Site Reference ID/Investigator# 33361

Bad Abbach, , Germany

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Site Reference ID/Investigator# 35142

Bad Aibling, , Germany

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Site Reference ID/Investigator# 35570

Bad Brambach, , Germany

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Site Reference ID/Investigator# 35573

Bad Bramstedt, , Germany

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Site Reference ID/Investigator# 33372

Bad Endbach, , Germany

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Site Reference ID/Investigator# 33378

Bad Iburg, , Germany

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Site Reference ID/Investigator# 33382

Bad Iburg, , Germany

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Site Reference ID/Investigator# 33387

Bad Kreuznach, , Germany

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Site Reference ID/Investigator# 35575

Bad Kreuznach, , Germany

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Site Reference ID/Investigator# 33391

Bad Liebenwerda, , Germany

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Site Reference ID/Investigator# 33396

Bad Münder am Deister, , Germany

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Site Reference ID/Investigator# 102216

Bad Nauheim, , Germany

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Site Reference ID/Investigator# 35578

Bad Neuenahr, , Germany

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Site Reference ID/Investigator# 33404

Bad Rappenau, , Germany

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Site Reference ID/Investigator# 51883

Bad Salzungen, , Germany

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Site Reference ID/Investigator# 33412

Bad Soden-Salmünster, , Germany

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Site Reference ID/Investigator# 33425

Baden-Baden, , Germany

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Site Reference ID/Investigator# 33429

Bamberg, , Germany

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Site Reference ID/Investigator# 33438

Bautzen, , Germany

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Site Reference ID/Investigator# 33442

Bayreuth, , Germany

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Site Reference ID/Investigator# 33446

Bayreuth, , Germany

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Site Reference ID/Investigator# 33641

Berlin, , Germany

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Site Reference ID/Investigator# 35089

Berlin, , Germany

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Site Reference ID/Investigator# 33648

Berlin, , Germany

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Site Reference ID/Investigator# 33693

Berlin, , Germany

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Site Reference ID/Investigator# 33670

Berlin, , Germany

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Site Reference ID/Investigator# 33658

Berlin, , Germany

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Site Reference ID/Investigator# 33697

Berlin, , Germany

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Site Reference ID/Investigator# 34246

Berlin, , Germany

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Site Reference ID/Investigator# 33683

Berlin, , Germany

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Site Reference ID/Investigator# 34269

Berlin, , Germany

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Site Reference ID/Investigator# 35527

Berlin, , Germany

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Site Reference ID/Investigator# 35597

Berlin, , Germany

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Site Reference ID/Investigator# 33620

Berlin, , Germany

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Site Reference ID/Investigator# 33690

Berlin, , Germany

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Site Reference ID/Investigator# 33704

Berlin, , Germany

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Site Reference ID/Investigator# 33687

Berlin, , Germany

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Site Reference ID/Investigator# 33661

Berlin, , Germany

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Site Reference ID/Investigator# 35550

Berlin, , Germany

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Site Reference ID/Investigator# 33674

Berlin, , Germany

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Site Reference ID/Investigator# 35551

Berlin, , Germany

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Site Reference ID/Investigator# 34238

Berlin, , Germany

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Site Reference ID/Investigator# 35556

Bernau, , Germany

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Site Reference ID/Investigator# 34277

Biberach, , Germany

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Site Reference ID/Investigator# 35562

Binzen, , Germany

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Site Reference ID/Investigator# 34285

Blankenburg/Hart, , Germany

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Site Reference ID/Investigator# 34288

Blaubeuren Abbey, , Germany

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Site Reference ID/Investigator# 34291

Bocholt, , Germany

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Site Reference ID/Investigator# 35566

Bocholt, , Germany

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Site Reference ID/Investigator# 35641

Bochum, , Germany

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Site Reference ID/Investigator# 35644

Bogen, , Germany

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Site Reference ID/Investigator# 34302

Bonn, , Germany

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Site Reference ID/Investigator# 35646

Bonn, , Germany

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Site Reference ID/Investigator# 34296

Bonn, , Germany

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Site Reference ID/Investigator# 35652

Bottrop, , Germany

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Site Reference ID/Investigator# 34307

Braunschweig, , Germany

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Site Reference ID/Investigator# 35603

Breitenbrunn, , Germany

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Site Reference ID/Investigator# 35609

Bremen, , Germany

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Site Reference ID/Investigator# 34266

Buch, , Germany

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Site Reference ID/Investigator# 35611

Celle, , Germany

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Site Reference ID/Investigator# 34699

Chemnitz, , Germany

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Site Reference ID/Investigator# 35093

Chemnitz, , Germany

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Site Reference ID/Investigator# 35615

Coesfeld, , Germany

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Site Reference ID/Investigator# 33989

Cologne, , Germany

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Site Reference ID/Investigator# 35237

Cologne, , Germany

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Site Reference ID/Investigator# 34708

Cottbus, , Germany

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Site Reference ID/Investigator# 34711

Cottbus, , Germany

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Site Reference ID/Investigator# 35621

Darmstadt, , Germany

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Site Reference ID/Investigator# 34725

Deggendorf, , Germany

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Site Reference ID/Investigator# 35631

Dessau, , Germany

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Site Reference ID/Investigator# 34742

Dortmund, , Germany

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Site Reference ID/Investigator# 35635

Dortmund, , Germany

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Site Reference ID/Investigator# 35634

Dortmund, , Germany

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Site Reference ID/Investigator# 35170

Dresden, , Germany

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Site Reference ID/Investigator# 34754

Dresden, , Germany

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Site Reference ID/Investigator# 34748

Dresden, , Germany

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Site Reference ID/Investigator# 34751

Dresden, , Germany

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Site Reference ID/Investigator# 34760

Dresden, , Germany

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Site Reference ID/Investigator# 34778

Duisburg, , Germany

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Site Reference ID/Investigator# 34773

Düsseldorf, , Germany

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Site Reference ID/Investigator# 34768

Düsseldorf, , Germany

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Site Reference ID/Investigator# 34784

Eberswalde, , Germany

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Site Reference ID/Investigator# 35184

Elmshorn, , Germany

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Site Reference ID/Investigator# 34809

Erfurt, , Germany

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Site Reference ID/Investigator# 35096

Erfurt, , Germany

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Site Reference ID/Investigator# 35191

Erfurt, , Germany

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Site Reference ID/Investigator# 34821

Erlangen, , Germany

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Site Reference ID/Investigator# 35196

Essen, , Germany

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Site Reference ID/Investigator# 35199

Essen, , Germany

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Site Reference ID/Investigator# 35202

Feldafing, , Germany

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Site Reference ID/Investigator# 35205

Flensburg, , Germany

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Site Reference ID/Investigator# 34833

Forchheim, , Germany

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Site Reference ID/Investigator# 35210

Frankenberg, , Germany

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Site Reference ID/Investigator# 34849

Frankfurt, , Germany

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Site Reference ID/Investigator# 34840

Frankfurt, , Germany

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Site Reference ID/Investigator# 34843

Frankfurt, , Germany

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Site Reference ID/Investigator# 35213

Fraureuth, , Germany

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Site Reference ID/Investigator# 35219

Freiberg, , Germany

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Site Reference ID/Investigator# 34854

Freiburg im Breisgau, , Germany

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Site Reference ID/Investigator# 35221

Freiburg im Breisgau, , Germany

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Site Reference ID/Investigator# 34861

Freiburg im Breisgau, , Germany

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Site Reference ID/Investigator# 35101

Freystadt, , Germany

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Site Reference ID/Investigator# 35224

Friedrichroda, , Germany

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Site Reference ID/Investigator# 34879

Gelsenkirchen, , Germany

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Site Reference ID/Investigator# 34883

Gera, , Germany

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Site Reference ID/Investigator# 34887

Giessen, , Germany

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Site Reference ID/Investigator# 35491

Gosheim, , Germany

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Site Reference ID/Investigator# 34896

Goslar, , Germany

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Site Reference ID/Investigator# 34901

Greifswald, , Germany

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Site Reference ID/Investigator# 35496

Greifswald, , Germany

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Site Reference ID/Investigator# 34904

Greifswald, , Germany

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Site Reference ID/Investigator# 102217

Groß Ammensleben, , Germany

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Site Reference ID/Investigator# 33897

Groß Reken, , Germany

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Site Reference ID/Investigator# 35498

Guben, , Germany

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Site Reference ID/Investigator# 34912

Güstrow, , Germany

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Site Reference ID/Investigator# 35503

Hagen, , Germany

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Site Reference ID/Investigator# 34937

Halle, , Germany

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Site Reference ID/Investigator# 34940

Halle, , Germany

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Site Reference ID/Investigator# 34922

Halle, , Germany

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Site Reference ID/Investigator# 34944

Halle, , Germany

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Site Reference ID/Investigator# 34932

Halle, , Germany

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Site Reference ID/Investigator# 35444

Hamburg, , Germany

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Site Reference ID/Investigator# 35441

Hamburg, , Germany

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Site Reference ID/Investigator# 34970

Hamburg, , Germany

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Site Reference ID/Investigator# 34952

Hamburg, , Germany

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Site Reference ID/Investigator# 34958

Hamburg, , Germany

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Site Reference ID/Investigator# 35452

Hamburg, , Germany

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Site Reference ID/Investigator# 35007

Hamburg, , Germany

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Site Reference ID/Investigator# 35000

Hamburg, , Germany

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Site Reference ID/Investigator# 34961

Hamburg, , Germany

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Site Reference ID/Investigator# 35449

Hamburg, , Germany

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Site Reference ID/Investigator# 34955

Hamburg, , Germany

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Site Reference ID/Investigator# 34998

Hamburg, , Germany

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Site Reference ID/Investigator# 34994

Hamburg, , Germany

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Site Reference ID/Investigator# 34983

Hamburg, , Germany

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Site Reference ID/Investigator# 34986

Hamburg, , Germany

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Site Reference ID/Investigator# 35111

Hamburg, , Germany

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Site Reference ID/Investigator# 34974

Hamburg, , Germany

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Site Reference ID/Investigator# 35019

Hanau, , Germany

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Site Reference ID/Investigator# 33712

Hanover, , Germany

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Site Reference ID/Investigator# 35025

Hanover, , Germany

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Site Reference ID/Investigator# 33792

Harrislee, , Germany

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Site Reference ID/Investigator# 35459

Haselünne, , Germany

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Site Reference ID/Investigator# 102215

Heidelberg, , Germany

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Site Reference ID/Investigator# 33798

Heidelberg, , Germany

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Site Reference ID/Investigator# 35119

Heidelberg, , Germany

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Site Reference ID/Investigator# 33801

Heidelberg, , Germany

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Site Reference ID/Investigator# 33808

Heidelberg, , Germany

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Site Reference ID/Investigator# 35464

Heidenheim, , Germany

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Site Reference ID/Investigator# 33818

Heilbad Heiligenstadt, , Germany

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Site Reference ID/Investigator# 33825

Herrsching am Ammersee, , Germany

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Site Reference ID/Investigator# 33834

Hof, , Germany

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Site Reference ID/Investigator# 33842

Hofheim, , Germany

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Site Reference ID/Investigator# 33845

Hohenfelde, , Germany

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Site Reference ID/Investigator# 33855

Illertissen, , Germany

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Site Reference ID/Investigator# 33858

Immenstadt im Allgäu, , Germany

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Site Reference ID/Investigator# 35479

Ingolstadt, , Germany

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Site Reference ID/Investigator# 51882

Jena, , Germany

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Site Reference ID/Investigator# 33942

Jülich, , Germany

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Site Reference ID/Investigator# 33946

Kahla, , Germany

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Site Reference ID/Investigator# 35125

Kahla, , Germany

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Site Reference ID/Investigator# 33950

Kaiserslautern, , Germany

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Site Reference ID/Investigator# 33956

Karlsruhe, , Germany

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Site Reference ID/Investigator# 33961

Karlsruhe, , Germany

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Site Reference ID/Investigator# 33964

Kassel, , Germany

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Site Reference ID/Investigator# 34002

Königs Wusterhausen, , Germany

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Site Reference ID/Investigator# 34008

Kressbronn, , Germany

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Site Reference ID/Investigator# 34084

Kronach, , Germany

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Site Reference ID/Investigator# 34005

Lahr, , Germany

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Site Reference ID/Investigator# 35245

Landau, , Germany

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Site Reference ID/Investigator# 34112

Leipzig, , Germany

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Site Reference ID/Investigator# 34106

Leipzig, , Germany

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Site Reference ID/Investigator# 34109

Leipzig, , Germany

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Site Reference ID/Investigator# 34100

Leipzig, , Germany

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Site Reference ID/Investigator# 35254

Lippstadt, , Germany

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Site Reference ID/Investigator# 35306

Ludwigsfelde, , Germany

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Site Reference ID/Investigator# 35262

Ludwigshafen, , Germany

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Site Reference ID/Investigator# 34136

Lübeck, , Germany

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Site Reference ID/Investigator# 34139

Lüneburg, , Germany

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Site Reference ID/Investigator# 34147

Magdeburg, , Germany

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Site Reference ID/Investigator# 34150

Magdeburg, , Germany

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Site Reference ID/Investigator# 35276

Mainz, , Germany

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Site Reference ID/Investigator# 34192

Marktredwitz, , Germany

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Site Reference ID/Investigator# 34196

Marl, , Germany

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Site Reference ID/Investigator# 34200

Meissen, , Germany

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Site Reference ID/Investigator# 35285

Menz, , Germany

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Site Reference ID/Investigator# 35287

Minden, , Germany

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Site Reference ID/Investigator# 34208

Mittelherwigsdorf, , Germany

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Site Reference ID/Investigator# 34221

Moenkeberg, , Germany

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Site Reference ID/Investigator# 34218

Mönchengladbach, , Germany

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Site Reference ID/Investigator# 34213

Mönchengladbach, , Germany

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Site Reference ID/Investigator# 34040

Munich, , Germany

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Site Reference ID/Investigator# 35295

Munich, , Germany

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Site Reference ID/Investigator# 34232

Munich, , Germany

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Site Reference ID/Investigator# 34235

Munich, , Germany

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Site Reference ID/Investigator# 35298

Munich, , Germany

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Site Reference ID/Investigator# 34043

Munich, , Germany

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Site Reference ID/Investigator# 34224

Mühlhausen, , Germany

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Site Reference ID/Investigator# 35292

Mülheim, , Germany

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Site Reference ID/Investigator# 34229

Müllheim, , Germany

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Site Reference ID/Investigator# 34048

Münster, , Germany

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Site Reference ID/Investigator# 34052

Naunhof, , Germany

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Site Reference ID/Investigator# 34061

Neubrandenburg, , Germany

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Site Reference ID/Investigator# 34064

Neuburg am Inn, , Germany

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Site Reference ID/Investigator# 34071

Neumünster, , Germany

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Site Reference ID/Investigator# 35313

Neuss, , Germany

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Site Reference ID/Investigator# 34076

Neustadt, , Germany

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Site Reference ID/Investigator# 35321

Niederbrombach, , Germany

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Site Reference ID/Investigator# 34080

Niefern-Öschelbronn, , Germany

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Site Reference ID/Investigator# 34158

Nienburg, , Germany

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Site Reference ID/Investigator# 34173

Oelsnitz, , Germany

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Site Reference ID/Investigator# 34176

Offenburg, , Germany

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Site Reference ID/Investigator# 33492

Oldenburg, , Germany

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Site Reference ID/Investigator# 34718

Ostseebad Damp, , Germany

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Site Reference ID/Investigator# 35335

Paderborn, , Germany

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Site Reference ID/Investigator# 33508

Parchim, , Germany

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Site Reference ID/Investigator# 35340

Passau, , Germany

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Site Reference ID/Investigator# 33517

Pfullendorf, , Germany

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Site Reference ID/Investigator# 67482

Pirna, , Germany

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Site Reference ID/Investigator# 33523

Planegg, , Germany

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Site Reference ID/Investigator# 33528

Plauen, , Germany

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Site Reference ID/Investigator# 33470

Potsdam, , Germany

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Site Reference ID/Investigator# 33466

Potsdam, , Germany

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Site Reference ID/Investigator# 33476

Prüm, , Germany

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Site Reference ID/Investigator# 33479

Püttlingen, , Germany

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Site Reference ID/Investigator# 33484

Radebeul, , Germany

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Site Reference ID/Investigator# 35347

Radebeul, , Germany

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Site Reference ID/Investigator# 35136

Ratingen, , Germany

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Site Reference ID/Investigator# 33488

Ratzeburg, , Germany

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Site Reference ID/Investigator# 33890

Regensburg, , Germany

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Site Reference ID/Investigator# 33883

Regensburg, , Germany

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Regensburg, , Germany

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Site Reference ID/Investigator# 33902

Rendsburg, , Germany

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Site Reference ID/Investigator# 33907

Rheine, , Germany

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Site Reference ID/Investigator# 35355

Rickenbach, , Germany

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Site Reference ID/Investigator# 33911

Riesa, , Germany

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Site Reference ID/Investigator# 33914

Rinteln, , Germany

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Site Reference ID/Investigator# 33923

Rostock, , Germany

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Site Reference ID/Investigator# 33927

Rostock, , Germany

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Site Reference ID/Investigator# 33931

Rothenburg, , Germany

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Site Reference ID/Investigator# 35362

Rüdersdorf, , Germany

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Site Reference ID/Investigator# 34016

Saarbrücken, , Germany

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Site Reference ID/Investigator# 35383

Saint Martin, , Germany

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Site Reference ID/Investigator# 34023

Salzwedel, , Germany

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Sande, , Germany

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Site Reference ID/Investigator# 33534

Schneeberg, , Germany

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Site Reference ID/Investigator# 33539

Schramberg, , Germany

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Site Reference ID/Investigator# 33542

Schutterwald, , Germany

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Site Reference ID/Investigator# 35371

Schwandorf in Bayern, , Germany

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Site Reference ID/Investigator# 33549

Schwerin, , Germany

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Site Reference ID/Investigator# 35376

Schwerin, , Germany

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Site Reference ID/Investigator# 33555

Schwerte, , Germany

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Site Reference ID/Investigator# 33559

Seesen, , Germany

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Site Reference ID/Investigator# 33563

Senden, , Germany

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Site Reference ID/Investigator# 35380

Singen, , Germany

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Site Reference ID/Investigator# 33567

Sinsheim, , Germany

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Site Reference ID/Investigator# 33572

Soltau, , Germany

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Site Reference ID/Investigator# 33577

Spremberg, , Germany

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Site Reference ID/Investigator# 33588

Stadthagen, , Germany

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Site Reference ID/Investigator# 33592

Steinhagen, , Germany

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Site Reference ID/Investigator# 33604

Stuttgart, , Germany

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Site Reference ID/Investigator# 33607

Stuttgart, , Germany

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Site Reference ID/Investigator# 33611

Stuttgart, , Germany

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Site Reference ID/Investigator# 33598

Stuttgart, , Germany

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Site Reference ID/Investigator# 35389

Suhl, , Germany

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Site Reference ID/Investigator# 35391

Tegernau, , Germany

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Site Reference ID/Investigator# 33625

Torgelow, , Germany

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Site Reference ID/Investigator# 33637

Ueberlingen-Nussdorf, , Germany

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Site Reference ID/Investigator# 35395

Uffenheim, , Germany

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Site Reference ID/Investigator# 33721

Ulm, , Germany

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Site Reference ID/Investigator# 33724

Ulm, , Germany

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Site Reference ID/Investigator# 33734

Viersen, , Germany

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Site Reference ID/Investigator# 33737

Villingen-Schwenningen, , Germany

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Site Reference ID/Investigator# 35397

Vöhringen, , Germany

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Site Reference ID/Investigator# 33742

Waltrop, , Germany

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Site Reference ID/Investigator# 34252

Wannsee, , Germany

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Site Reference ID/Investigator# 33749

Weener, , Germany

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Site Reference ID/Investigator# 33751

Weißenfels, , Germany

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Site Reference ID/Investigator# 33852

Welzow, , Germany

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Site Reference ID/Investigator# 35404

Wiefelstede, , Germany

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Site Reference ID/Investigator# 33761

Wiesbaden, , Germany

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Site Reference ID/Investigator# 35408

Wiesbaden, , Germany

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Site Reference ID/Investigator# 33765

Wiesbaden, , Germany

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Site Reference ID/Investigator# 35413

Wiesbaden, , Germany

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Site Reference ID/Investigator# 33772

Wilhelmshaven, , Germany

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Site Reference ID/Investigator# 33780

Wittlich, , Germany

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Site Reference ID/Investigator# 35420

Wuppertal, , Germany

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Site Reference ID/Investigator# 33718

Würzburg, , Germany

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Site Reference ID/Investigator# 33864

Zerbst, , Germany

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Site Reference ID/Investigator# 33867

Zeven, , Germany

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Site Reference ID/Investigator# 33873

Zwickau, , Germany

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Site Reference ID/Investigator# 33876

Zwickau, , Germany

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Site Reference ID/Investigator# 33880

Zwiesel, , Germany

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Countries

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Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31311386 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26990995 (View on PubMed)

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Other Identifiers

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P10-448

Identifier Type: -

Identifier Source: org_study_id

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