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

NCT01077258 | Completed Results

• 1 other identifier: P10-448
• Study Type: observational
• Target: 4,208
• Locations: 1 country
• Sites: 303

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Safety; Long-term observation; Routine Clinical Setting; Rheumatoid Arthritis; Effectiveness

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Disease Activity Score (DAS) 28

  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.

  Baseline and Months 3, 6, 9, 12, 18, and 24

• Percentage of Participants in DAS28 Remission

  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.

  Months 3, 6, 9, 12, 18, and 24

Secondary Outcomes (14)

• Percentage of Participants With a Significant Therapeutic Response

  Baseline and Months 3, 6, 9, 12, 18, and 24

• Percentage of Participants With Low, Moderate and High Disease Activity

  Baseline and Months 3, 6, 9, 12, 18, and 24

• Erythrocyte Sedimentation Rate (ESR) Over Time

  Baseline and Months 3, 6, 9, 12, 18, and 24

• C-Reactive Protein (CRP) Levels Over Time

  Baseline and Months 3, 6, 9, 12, 18, and 24

• Tender Joint Count (TJC) Over Time

  Baseline and Months 3, 6, 9, 12, 18, and 24

Study Arms (1)

Rheumatoid arthritis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (303)

Site Reference ID/Investigator# 35036

Aachen, 52062, Germany

Location

Site Reference ID/Investigator# 35510

Ahlen, 59227, Germany

Location

Site Reference ID/Investigator# 35040

Ahrensburg, 22926, Germany

Location

Site Reference ID/Investigator# 35043

Altenburg, 04600, Germany

Location

Site Reference ID/Investigator# 35046

Altenholz, 24161, Germany

Location

Site Reference ID/Investigator# 35049

Amberg, 92224, Germany

Location

Site Reference ID/Investigator# 35057

Arnstadt, 99310, Germany

Location

Site Reference ID/Investigator# 35520

Attendorn, 57439, Germany

Location

Site Reference ID/Investigator# 33349

Augsburg, 86150, Germany

Location

Site Reference ID/Investigator# 33358

Bad Abbach, 93077, Germany

Location

Site Reference ID/Investigator# 33361

Bad Abbach, 93077, Germany

Location

Site Reference ID/Investigator# 35142

Bad Aibling, 83043, Germany

Location

Site Reference ID/Investigator# 35570

Bad Brambach, 8648, Germany

Location

Site Reference ID/Investigator# 35573

Bad Bramstedt, 24576, Germany

Location

Site Reference ID/Investigator# 33372

Bad Endbach, 35080, Germany

Location

Site Reference ID/Investigator# 33378

Bad Iburg, 49186, Germany

Location

Site Reference ID/Investigator# 33382

Bad Iburg, 49186, Germany

Location

Site Reference ID/Investigator# 33387

Bad Kreuznach, 55543, Germany

Location

Site Reference ID/Investigator# 35575

Bad Kreuznach, 55543, Germany

Location

Site Reference ID/Investigator# 33391

Bad Liebenwerda, 04924, Germany

Location

Site Reference ID/Investigator# 33396

Bad Münder am Deister, 31848, Germany

Location

Site Reference ID/Investigator# 102216

Bad Nauheim, 61231, Germany

Location

Site Reference ID/Investigator# 35578

Bad Neuenahr, 53474, Germany

Location

Site Reference ID/Investigator# 33404

Bad Rappenau, 74906, Germany

Location

Site Reference ID/Investigator# 51883

Bad Salzungen, 36433, Germany

Location

Site Reference ID/Investigator# 33412

Bad Soden-Salmünster, 63628, Germany

Location

Site Reference ID/Investigator# 33425

Baden-Baden, 76530, Germany

Location

Site Reference ID/Investigator# 33429

Bamberg, 96047, Germany

Location

Site Reference ID/Investigator# 33438

Bautzen, 02625, Germany

Location

Site Reference ID/Investigator# 33442

Bayreuth, 95445, Germany

Location

Site Reference ID/Investigator# 33446

Bayreuth, 95445, Germany

Location

Site Reference ID/Investigator# 33641

Berlin, 10117, Germany

Location

Site Reference ID/Investigator# 35089

Berlin, 10117, Germany

Location

Site Reference ID/Investigator# 33648

Berlin, 10178, Germany

Location

Site Reference ID/Investigator# 33693

Berlin, 10247, Germany

Location

Site Reference ID/Investigator# 33670

Berlin, 10369, Germany

Location

Site Reference ID/Investigator# 33658

Berlin, 10435, Germany

Location

Site Reference ID/Investigator# 33697

Berlin, 10711, Germany

Location

Site Reference ID/Investigator# 34246

Berlin, 10719, Germany

Location

Site Reference ID/Investigator# 33683

Berlin, 10777, Germany

Location

Site Reference ID/Investigator# 34269

Berlin, 10961, Germany

Location

Site Reference ID/Investigator# 35527

Berlin, 12161, Germany

Location

Site Reference ID/Investigator# 35597

Berlin, 12161, Germany

Location

Site Reference ID/Investigator# 33620

Berlin, 12207, Germany

Location

Site Reference ID/Investigator# 33690

Berlin, 12435, Germany

Location

Site Reference ID/Investigator# 33704

Berlin, 12435, Germany

Location

Site Reference ID/Investigator# 33687

Berlin, 13055, Germany

Location

Site Reference ID/Investigator# 33661

Berlin, 13437, Germany

Location

Site Reference ID/Investigator# 35550

Berlin, 13595, Germany

Location

Site Reference ID/Investigator# 33674

Berlin, 14109, Germany

Location

Site Reference ID/Investigator# 35551

Berlin, 14163, Germany

Location

Site Reference ID/Investigator# 34238

Berlin, 14199, Germany

Location

Site Reference ID/Investigator# 35556

Bernau, 16321, Germany

Location

Site Reference ID/Investigator# 34277

Biberach, 88400, Germany

Location

Site Reference ID/Investigator# 35562

Binzen, 79589, Germany

Location

Site Reference ID/Investigator# 34285

Blankenburg/Hart, 38889, Germany

Location

Site Reference ID/Investigator# 34288

Blaubeuren Abbey, 89143, Germany

Location

Site Reference ID/Investigator# 34291

Bocholt, 46399, Germany

Location

Site Reference ID/Investigator# 35566

Bocholt, 46399, Germany

Location

Site Reference ID/Investigator# 35641

Bochum, 44789, Germany

Location

Site Reference ID/Investigator# 35644

Bogen, 94327, Germany

Location

Site Reference ID/Investigator# 34302

Bonn, 53111, Germany

Location

Site Reference ID/Investigator# 35646

Bonn, 53129, Germany

Location

Site Reference ID/Investigator# 34296

Bonn, 53177, Germany

Location

Site Reference ID/Investigator# 35652

Bottrop, 46242, Germany

Location

Site Reference ID/Investigator# 34307

Braunschweig, 38100, Germany

Location

Site Reference ID/Investigator# 35603

Breitenbrunn, 08359, Germany

Location

Site Reference ID/Investigator# 35609

Bremen, 28209, Germany

Location

Site Reference ID/Investigator# 34266

Buch, 13125, Germany

Location

Site Reference ID/Investigator# 35611

Celle, 29223, Germany

Location

Site Reference ID/Investigator# 34699

Chemnitz, 09126, Germany

Location

Site Reference ID/Investigator# 35093

Chemnitz, D-09130, Germany

Location

Site Reference ID/Investigator# 35615

Coesfeld, 48653, Germany

Location

Site Reference ID/Investigator# 33989

Cologne, 50823, Germany

Location

Site Reference ID/Investigator# 35237

Cologne, 51067, Germany

Location

Site Reference ID/Investigator# 34708

Cottbus, 03042, Germany

Location

Site Reference ID/Investigator# 34711

Cottbus, 03046, Germany

Location

Site Reference ID/Investigator# 35621

Darmstadt, 64295, Germany

Location

Site Reference ID/Investigator# 34725

Deggendorf, 94469, Germany

Location

Site Reference ID/Investigator# 35631

Dessau, 6842, Germany

Location

Site Reference ID/Investigator# 34742

Dortmund, 44147, Germany

Location

Site Reference ID/Investigator# 35635

Dortmund, 44147, Germany

Location

Site Reference ID/Investigator# 35634

Dortmund, 44263, Germany

Location

Site Reference ID/Investigator# 35170

Dresden, 01097, Germany

Location

Site Reference ID/Investigator# 34754

Dresden, 01109, Germany

Location

Site Reference ID/Investigator# 34748

Dresden, 01277, Germany

Location

Site Reference ID/Investigator# 34751

Dresden, 01277, Germany

Location

Site Reference ID/Investigator# 34760

Dresden, 01277, Germany

Location

Site Reference ID/Investigator# 34778

Duisburg, 47055, Germany

Location

Site Reference ID/Investigator# 34773

Düsseldorf, 40211, Germany

Location

Site Reference ID/Investigator# 34768

Düsseldorf, 40217, Germany

Location

Site Reference ID/Investigator# 34784

Eberswalde, 16225, Germany

Location

Site Reference ID/Investigator# 35184

Elmshorn, 25336, Germany

Location

Site Reference ID/Investigator# 34809

Erfurt, 99096, Germany

Location

Site Reference ID/Investigator# 35096

Erfurt, 99096, Germany

Location

Site Reference ID/Investigator# 35191

Erfurt, 99096, Germany

Location

Site Reference ID/Investigator# 34821

Erlangen, 91056, Germany

Location

Site Reference ID/Investigator# 35196

Essen, 45326, Germany

Location

Site Reference ID/Investigator# 35199

Essen, 45356, Germany

Location

Site Reference ID/Investigator# 35202

Feldafing, 82340, Germany

Location

Site Reference ID/Investigator# 35205

Flensburg, 24937, Germany

Location

Site Reference ID/Investigator# 34833

Forchheim, 91301, Germany

Location

Site Reference ID/Investigator# 35210

Frankenberg, 09669, Germany

Location

Site Reference ID/Investigator# 34849

Frankfurt, 15230, Germany

Location

Site Reference ID/Investigator# 34840

Frankfurt, 60596, Germany

Location

Site Reference ID/Investigator# 34843

Frankfurt, 60596, Germany

Location

Site Reference ID/Investigator# 35213

Fraureuth, 08427, Germany

Location

Site Reference ID/Investigator# 35219

Freiberg, 09599, Germany

Location

Site Reference ID/Investigator# 34854

Freiburg im Breisgau, 79098, Germany

Location

Site Reference ID/Investigator# 35221

Freiburg im Breisgau, 79104, Germany

Location

Site Reference ID/Investigator# 34861

Freiburg im Breisgau, 79106, Germany

Location

Site Reference ID/Investigator# 35101

Freystadt, 92342, Germany

Location

Site Reference ID/Investigator# 35224

Friedrichroda, 99894, Germany

Location

Site Reference ID/Investigator# 34879

Gelsenkirchen, 45881, Germany

Location

Site Reference ID/Investigator# 34883

Gera, 07545, Germany

Location

Site Reference ID/Investigator# 34887

Giessen, 35392, Germany

Location

Site Reference ID/Investigator# 35491

Gosheim, 78559, Germany

Location

Site Reference ID/Investigator# 34896

Goslar, 38642, Germany

Location

Site Reference ID/Investigator# 34901

Greifswald, 17489, Germany

Location

Site Reference ID/Investigator# 35496

Greifswald, 17489, Germany

Location

Site Reference ID/Investigator# 34904

Greifswald, 17491, Germany

Location

Site Reference ID/Investigator# 102217

Groß Ammensleben, 39326, Germany

Location

Site Reference ID/Investigator# 33897

Groß Reken, 48734, Germany

Location

Site Reference ID/Investigator# 35498

Guben, 3172, Germany

Location

Site Reference ID/Investigator# 34912

Güstrow, 18273, Germany

Location

Site Reference ID/Investigator# 35503

Hagen, 58089, Germany

Location

Site Reference ID/Investigator# 34937

Halle, 06108, Germany

Location

Site Reference ID/Investigator# 34940

Halle, 06108, Germany

Location

Site Reference ID/Investigator# 34922

Halle, 06112, Germany

Location

Site Reference ID/Investigator# 34944

Halle, 06120, Germany

Location

Site Reference ID/Investigator# 34932

Halle, 06128, Germany

Location

Site Reference ID/Investigator# 35444

Hamburg, 20144, Germany

Location

Site Reference ID/Investigator# 35441

Hamburg, 20148, Germany

Location

Site Reference ID/Investigator# 34970

Hamburg, 20251, Germany

Location

Site Reference ID/Investigator# 34952

Hamburg, 20355, Germany

Location

Site Reference ID/Investigator# 34958

Hamburg, 21075, Germany

Location

Site Reference ID/Investigator# 35452

Hamburg, 22081, Germany

Location

Site Reference ID/Investigator# 35007

Hamburg, 22089, Germany

Location

Site Reference ID/Investigator# 35000

Hamburg, 22119, Germany

Location

Site Reference ID/Investigator# 34961

Hamburg, 22147, Germany

Location

Site Reference ID/Investigator# 35449

Hamburg, 22179, Germany

Location

Site Reference ID/Investigator# 34955

Hamburg, 22415, Germany

Location

Site Reference ID/Investigator# 34998

Hamburg, 22459, Germany

Location

Site Reference ID/Investigator# 34994

Hamburg, 22523, Germany

Location

Site Reference ID/Investigator# 34983

Hamburg, 22609, Germany

Location

Site Reference ID/Investigator# 34986

Hamburg, 22609, Germany

Location

Site Reference ID/Investigator# 35111

Hamburg, 22609, Germany

Location

Site Reference ID/Investigator# 34974

Hamburg, 22767, Germany

Location

Site Reference ID/Investigator# 35019

Hanau, 63450, Germany

Location

Site Reference ID/Investigator# 33712

Hanover, 30159, Germany

Location

Site Reference ID/Investigator# 35025

Hanover, 30159, Germany

Location

Site Reference ID/Investigator# 33792

Harrislee, 24955, Germany

Location

Site Reference ID/Investigator# 35459

Haselünne, 49740, Germany

Location

Site Reference ID/Investigator# 102215

Heidelberg, 69120, Germany

Location

Site Reference ID/Investigator# 33798

Heidelberg, 69120, Germany

Location

Site Reference ID/Investigator# 35119

Heidelberg, 69120, Germany

Location

Site Reference ID/Investigator# 33801

Heidelberg, 69121, Germany

Location

Site Reference ID/Investigator# 33808

Heidelberg, 69121, Germany

Location

Site Reference ID/Investigator# 35464

Heidenheim, 89520, Germany

Location

Site Reference ID/Investigator# 33818

Heilbad Heiligenstadt, 37308, Germany

Location

Site Reference ID/Investigator# 33825

Herrsching am Ammersee, 82211, Germany

Location

Site Reference ID/Investigator# 33834

Hof, 95028, Germany

Location

Site Reference ID/Investigator# 33842

Hofheim, 65719, Germany

Location

Site Reference ID/Investigator# 33845

Hohenfelde, 18209, Germany

Location

Site Reference ID/Investigator# 33855

Illertissen, 89257, Germany

Location

Site Reference ID/Investigator# 33858

Immenstadt im Allgäu, 87509, Germany

Location

Site Reference ID/Investigator# 35479

Ingolstadt, 85049, Germany

Location

Site Reference ID/Investigator# 51882

Jena, 07743, Germany

Location

Site Reference ID/Investigator# 33942

Jülich, 52428, Germany

Location

Site Reference ID/Investigator# 33946

Kahla, 07768, Germany

Location

Site Reference ID/Investigator# 35125

Kahla, 07768, Germany

Location

Site Reference ID/Investigator# 33950

Kaiserslautern, 67655, Germany

Location

Site Reference ID/Investigator# 33956

Karlsruhe, 76133, Germany

Location

Site Reference ID/Investigator# 33961

Karlsruhe, 76133, Germany

Location

Site Reference ID/Investigator# 33964

Kassel, 34131, Germany

Location

Site Reference ID/Investigator# 34002

Königs Wusterhausen, 15711, Germany

Location

Site Reference ID/Investigator# 34008

Kressbronn, 88079, Germany

Location

Site Reference ID/Investigator# 34084

Kronach, 96317, Germany

Location

Site Reference ID/Investigator# 34005

Lahr, 77933, Germany

Location

Site Reference ID/Investigator# 35245

Landau, 76829, Germany

Location

Site Reference ID/Investigator# 34112

Leipzig, 04109, Germany

Location

Site Reference ID/Investigator# 34106

Leipzig, 04129, Germany

Location

Site Reference ID/Investigator# 34109

Leipzig, 04207, Germany

Location

Site Reference ID/Investigator# 34100

Leipzig, 04299, Germany

Location

Site Reference ID/Investigator# 35254

Lippstadt, 59555, Germany

Location

Site Reference ID/Investigator# 35306

Ludwigsfelde, 14974, Germany

Location

Site Reference ID/Investigator# 35262

Ludwigshafen, 67069, Germany

Location

Site Reference ID/Investigator# 34136

Lübeck, 23564, Germany

Location

Site Reference ID/Investigator# 34139

Lüneburg, 21335, Germany

Location

Site Reference ID/Investigator# 34147

Magdeburg, 39104, Germany

Location

Site Reference ID/Investigator# 34150

Magdeburg, 39104, Germany

Location

Site Reference ID/Investigator# 35276

Mainz, 55116, Germany

Location

Site Reference ID/Investigator# 34192

Marktredwitz, 95615, Germany

Location

Site Reference ID/Investigator# 34196

Marl, 45768, Germany

Location

Site Reference ID/Investigator# 34200

Meissen, 01662, Germany

Location

Site Reference ID/Investigator# 35285

Menz, 39175, Germany

Location

Site Reference ID/Investigator# 35287

Minden, 32429, Germany

Location

Site Reference ID/Investigator# 34208

Mittelherwigsdorf, 02763, Germany

Location

Site Reference ID/Investigator# 34221

Moenkeberg, 24248, Germany

Location

Site Reference ID/Investigator# 34218

Mönchengladbach, 41061, Germany

Location

Site Reference ID/Investigator# 34213

Mönchengladbach, 41199, Germany

Location

Site Reference ID/Investigator# 34040

Munich, 80639, Germany

Location

Site Reference ID/Investigator# 35295

Munich, 81377, Germany

Location

Site Reference ID/Investigator# 34232

Munich, 81547, Germany

Location

Site Reference ID/Investigator# 34235

Munich, 81547, Germany

Location

Site Reference ID/Investigator# 35298

Munich, 81667, Germany

Location

Site Reference ID/Investigator# 34043

Munich, 81925, Germany

Location

Site Reference ID/Investigator# 34224

Mühlhausen, 99974, Germany

Location

Site Reference ID/Investigator# 35292

Mülheim, 45468, Germany

Location

Site Reference ID/Investigator# 34229

Müllheim, 79379, Germany

Location

Site Reference ID/Investigator# 34048

Münster, 48149, Germany

Location

Site Reference ID/Investigator# 34052

Naunhof, 04683, Germany

Location

Site Reference ID/Investigator# 34061

Neubrandenburg, 17033, Germany

Location

Site Reference ID/Investigator# 34064

Neuburg am Inn, 86633, Germany

Location

Site Reference ID/Investigator# 34071

Neumünster, 24534, Germany

Location

Site Reference ID/Investigator# 35313

Neuss, 41460, Germany

Location

Site Reference ID/Investigator# 34076

Neustadt, 67434, Germany

Location

Site Reference ID/Investigator# 35321

Niederbrombach, 55767, Germany

Location

Site Reference ID/Investigator# 34080

Niefern-Öschelbronn, 75223, Germany

Location

Site Reference ID/Investigator# 34158

Nienburg, 31582, Germany

Location

Site Reference ID/Investigator# 34173

Oelsnitz, 09376, Germany

Location

Site Reference ID/Investigator# 34176

Offenburg, 77652, Germany

Location

Site Reference ID/Investigator# 33492

Oldenburg, 26121, Germany

Location

Site Reference ID/Investigator# 34718

Ostseebad Damp, 24351, Germany

Location

Site Reference ID/Investigator# 35335

Paderborn, 33098, Germany

Location

Site Reference ID/Investigator# 33508

Parchim, 19370, Germany

Location

Site Reference ID/Investigator# 35340

Passau, 94032, Germany

Location

Site Reference ID/Investigator# 33517

Pfullendorf, 88630, Germany

Location

Site Reference ID/Investigator# 67482

Pirna, 01796, Germany

Location

Site Reference ID/Investigator# 33523

Planegg, 82152, Germany

Location

Site Reference ID/Investigator# 33528

Plauen, 08523, Germany

Location

Site Reference ID/Investigator# 33470

Potsdam, 14467, Germany

Location

Site Reference ID/Investigator# 33466

Potsdam, 14469, Germany

Location

Site Reference ID/Investigator# 33476

Prüm, 54595, Germany

Location

Site Reference ID/Investigator# 33479

Püttlingen, 66346, Germany

Location

Site Reference ID/Investigator# 33484

Radebeul, 01445, Germany

Location

Site Reference ID/Investigator# 35347

Radebeul, 01445, Germany

Location

Site Reference ID/Investigator# 35136

Ratingen, 40882, Germany

Location

Site Reference ID/Investigator# 33488

Ratzeburg, 23909, Germany

Location

Site Reference ID/Investigator# 33890

Regensburg, 93049, Germany

Location

Site Reference ID/Investigator# 33883

Regensburg, 93051, Germany

Location

Site Reference ID/Investigator# 33886

Regensburg, 93051, Germany

Location

Site Reference ID/Investigator# 33902

Rendsburg, 24768, Germany

Location

Site Reference ID/Investigator# 33907

Rheine, 48431, Germany

Location

Site Reference ID/Investigator# 35355

Rickenbach, 79736, Germany

Location

Site Reference ID/Investigator# 33911

Riesa, 01589, Germany

Location

Site Reference ID/Investigator# 33914

Rinteln, 31737, Germany

Location

Site Reference ID/Investigator# 33923

Rostock, 18059, Germany

Location

Site Reference ID/Investigator# 33927

Rostock, 18059, Germany

Location

Site Reference ID/Investigator# 33931

Rothenburg, 02929, Germany

Location

Site Reference ID/Investigator# 35362

Rüdersdorf, 15562, Germany

Location

Site Reference ID/Investigator# 34016

Saarbrücken, 66111, Germany

Location

Site Reference ID/Investigator# 35383

Saint Martin, 67487, Germany

Location

Site Reference ID/Investigator# 34023

Salzwedel, 29410, Germany

Location

Site Reference ID/Investigator# 34027

Sande, 26452, Germany

Location

Site Reference ID/Investigator# 33534

Schneeberg, 08289, Germany

Location

Site Reference ID/Investigator# 33539

Schramberg, 78713, Germany

Location

Site Reference ID/Investigator# 33542

Schutterwald, 77746, Germany

Location

Site Reference ID/Investigator# 35371

Schwandorf in Bayern, 92421, Germany

Location

Site Reference ID/Investigator# 33549

Schwerin, 19053, Germany

Location

Site Reference ID/Investigator# 35376

Schwerin, 19053, Germany

Location

Site Reference ID/Investigator# 33555

Schwerte, 58239, Germany

Location

Site Reference ID/Investigator# 33559

Seesen, 38723, Germany

Location

Site Reference ID/Investigator# 33563

Senden, 48308, Germany

Location

Site Reference ID/Investigator# 35380

Singen, 78224, Germany

Location

Site Reference ID/Investigator# 33567

Sinsheim, 74889, Germany

Location

Site Reference ID/Investigator# 33572

Soltau, 29614, Germany

Location

Site Reference ID/Investigator# 33577

Spremberg, 03130, Germany

Location

Site Reference ID/Investigator# 33588

Stadthagen, 31655, Germany

Location

Site Reference ID/Investigator# 33592

Steinhagen, 33803, Germany

Location

Site Reference ID/Investigator# 33604

Stuttgart, 70178, Germany

Location

Site Reference ID/Investigator# 33607

Stuttgart, 70178, Germany

Location

Site Reference ID/Investigator# 33611

Stuttgart, 70199, Germany

Location

Site Reference ID/Investigator# 33598

Stuttgart, 70372, Germany

Location

Site Reference ID/Investigator# 35389

Suhl, 98529, Germany

Location

Site Reference ID/Investigator# 35391

Tegernau, 79692, Germany

Location

Site Reference ID/Investigator# 33625

Torgelow, 17358, Germany

Location

Site Reference ID/Investigator# 33637

Ueberlingen-Nussdorf, 88662, Germany

Location

Site Reference ID/Investigator# 35395

Uffenheim, 97215, Germany

Location

Site Reference ID/Investigator# 33721

Ulm, 89073, Germany

Location

Site Reference ID/Investigator# 33724

Ulm, 89073, Germany

Location

Site Reference ID/Investigator# 33734

Viersen, 41747, Germany

Location

Site Reference ID/Investigator# 33737

Villingen-Schwenningen, 78054, Germany

Location

Site Reference ID/Investigator# 35397

Vöhringen, 72189, Germany

Location

Site Reference ID/Investigator# 33742

Waltrop, 45731, Germany

Location

Site Reference ID/Investigator# 34252

Wannsee, 14109, Germany

Location

Site Reference ID/Investigator# 33749

Weener, 26826, Germany

Location

Site Reference ID/Investigator# 33751

Weißenfels, 06667, Germany

Location

Site Reference ID/Investigator# 33852

Welzow, 03119, Germany

Location

Site Reference ID/Investigator# 35404

Wiefelstede, 26215, Germany

Location

Site Reference ID/Investigator# 33761

Wiesbaden, 65189, Germany

Location

Site Reference ID/Investigator# 35408

Wiesbaden, 65189, Germany

Location

Site Reference ID/Investigator# 33765

Wiesbaden, 65191, Germany

Location

Site Reference ID/Investigator# 35413

Wiesbaden, 65191, Germany

Location

Site Reference ID/Investigator# 33772

Wilhelmshaven, 26382, Germany

Location

Site Reference ID/Investigator# 33780

Wittlich, 54516, Germany

Location

Site Reference ID/Investigator# 35420

Wuppertal, 42105, Germany

Location

Site Reference ID/Investigator# 33718

Würzburg, 97070, Germany

Location

Site Reference ID/Investigator# 33864

Zerbst, 39261, Germany

Location

Site Reference ID/Investigator# 33867

Zeven, 27404, Germany

Location

Site Reference ID/Investigator# 33873

Zwickau, 08056, Germany

Location

Site Reference ID/Investigator# 33876

Zwickau, 08060, Germany

Location

Site Reference ID/Investigator# 33880

Zwiesel, 94227, Germany

Location

Related Publications (2)

• 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.

  PMID: 31311386 DERIVED

• 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.

  PMID: 26990995 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Bianca Wittig, MD

  AbbVie Deutschland GmbH & Co. KG, Medical Department

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: April 1, 2004
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 25, 2014
• Results First Posted: April 8, 2014

Record last verified: 2014-04

Locations

DE (303)