AzTrials
AzTrials

Psoriatic ArthritisNCT01111240

Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice

An observational study of Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott) at 509 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
How many people
4,635 participants
Where
509 sitesGermany
Study dates
Aug 2005to Dec 2013
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Clinical routine patients with psoriatic arthritis

Who may be able to join

  • 18 years of age or older (younger patients may be enrolled at the discretion of physician)
  • Diagnosis of Psoriatic Arthritis (or any indication at the discretion of physician) and initiating adalimumab therapy
  • Signed/dated Informed Consent

Who cannot join

  • -None

Trial locations and contacts

509 sites in 1 country.

300 sites in 1 country

Germany300 sites

  • Site Reference ID/Investigator# 35035

    Aachen, 52062

  • Site Reference ID/Investigator# 64288

    Aachen, 52062

  • Site Reference ID/Investigator# 35509

    Ahlen, 59227

  • Site Reference ID/Investigator# 53118

    Ahrensburg, 22926

  • Site Reference ID/Investigator# 35042

    Altenburg, 04600

  • Site Reference ID/Investigator# 35045

    Altenholz, 24161

  • Site Reference ID/Investigator# 35048

    Amberg, 92224

  • Site Reference ID/Investigator# 96243

    Annaberg-Buchholz, 9456

  • Site Reference ID/Investigator# 53205

    Arnstadt, 99310

  • Site Reference ID/Investigator# 53091

    Artern, 06556

  • Site Reference ID/Investigator# 33348

    Augsburg, 86150

  • Site Reference ID/Investigator# 33357

    Bad Abbach, 93077

  • Site Reference ID/Investigator# 35085

    Bad Aibling, 83043

  • Site Reference ID/Investigator# 57895

    Bad Aibling, 83043

  • Site Reference ID/Investigator# 91097

    Bad Bentheim, 48455

  • Site Reference ID/Investigator# 35524

    Bad Bentheim, D-48455

  • Site Reference ID/Investigator# 35572

    Bad Bramstedt, 24576

  • Site Reference ID/Investigator# 64304

    Bad Bramstedt, 24576

  • Site Reference ID/Investigator# 33371

    Bad Endbach, 35080

  • Site Reference ID/Investigator# 53278

    Bad Endbach, 63065

  • Site Reference ID/Investigator# 91084

    Bad Homburg, 61348

  • Site Reference ID/Investigator# 33377

    Bad Iburg, 49186

  • Site Reference ID/Investigator# 33381

    Bad Iburg, 49186

  • Site Reference ID/Investigator# 53068

    Bad Kissingen, 97688

  • Site Reference ID/Investigator# 33386

    Bad Kreuznach, 55543

  • Site Reference ID/Investigator# 35574

    Bad Kreuznach, 55543

  • Site Reference ID/Investigator# 33390

    Bad Liebenwerda, 04924

  • Site Reference ID/Investigator# 33395

    Bad Münder am Deister, 31848

  • Site Reference ID/Investigator# 96245

    Bad Münder am Deister, 31848

  • Site Reference ID/Investigator# 91094

    Bad Nauheim, 61231

  • Site Reference ID/Investigator# 35577

    Bad Neuenahr, 53474

  • Site Reference ID/Investigator# 53181

    Bad Neuenahr, 53474

  • Site Reference ID/Investigator# 57885

    Bad Oeynhausen, 32545

  • Site Reference ID/Investigator# 33403

    Bad Rappenau, 74906

  • Site Reference ID/Investigator# 53060

    Bad Salzungen, 36433

  • Site Reference ID/Investigator# 91079

    Bad Salzungen, 36433

  • Site Reference ID/Investigator# 53254

    Bad Schlema, 8301

  • Site Reference ID/Investigator# 33416

    Bad Staffelstein, 96231

  • Site Reference ID/Investigator# 33420

    Bad Sülze, 18334

  • Site Reference ID/Investigator# 57890

    Bad Tölz, 83646

  • Site Reference ID/Investigator# 33424

    Baden-Baden, 76530

  • Site Reference ID/Investigator# 33428

    Bamberg, 96047

  • Site Reference ID/Investigator# 33434

    Bautzen, 02625

  • Site Reference ID/Investigator# 33437

    Bautzen, 02625

  • Site Reference ID/Investigator# 53231

    Bayreuth, 95444

  • Site Reference ID/Investigator# 33441

    Bayreuth, 95445

  • Site Reference ID/Investigator# 33445

    Bayreuth, 95445

  • Site Reference ID/Investigator# 68595

    Bergen, 18528

  • Site Reference ID/Investigator# 33459

    Berlin, 10117

  • Site Reference ID/Investigator# 35087

    Berlin, 10117

  • Site Reference ID/Investigator# 53058

    Berlin, 10117

  • Site Reference ID/Investigator# 53241

    Berlin, 10117

  • Site Reference ID/Investigator# 53242

    Berlin, 10117

  • Site Reference ID/Investigator# 33647

    Berlin, 10178

  • Site Reference ID/Investigator# 57909

    Berlin, 10178

  • Site Reference ID/Investigator# 53061

    Berlin, 10243

  • Site Reference ID/Investigator# 53059

    Berlin, 10369

  • Site Reference ID/Investigator# 68842

    Berlin, 10369

  • Site Reference ID/Investigator# 33657

    Berlin, 10435

  • Site Reference ID/Investigator# 53105

    Berlin, 10709

  • Site Reference ID/Investigator# 98535

    Berlin, 10713

  • Site Reference ID/Investigator# 34245

    Berlin, 10719

  • Site Reference ID/Investigator# 33682

    Berlin, 10777

  • Site Reference ID/Investigator# 68594

    Berlin, 10827

  • Site Reference ID/Investigator# 34268

    Berlin, 10961

  • Site Reference ID/Investigator# 33654

    Berlin, 12159

  • Site Reference ID/Investigator# 64284

    Berlin, 12159

  • Site Reference ID/Investigator# 35596

    Berlin, 12161

  • Site Reference ID/Investigator# 35600

    Berlin, 12161

  • Site Reference ID/Investigator# 53081

    Berlin, 12353

  • Site Reference ID/Investigator# 53244

    Berlin, 12435

  • Site Reference ID/Investigator# 91075

    Berlin, 12435

  • Site Reference ID/Investigator# 64287

    Berlin, 12437

  • Site Reference ID/Investigator# 34261

    Berlin, 12681

  • Site Reference ID/Investigator# 33686

    Berlin, 13055

  • Site Reference ID/Investigator# 64286

    Berlin, 13407

  • Site Reference ID/Investigator# 52990

    Berlin, 13507

  • Site Reference ID/Investigator# 52995

    Berlin, 13507

  • Site Reference ID/Investigator# 35549

    Berlin, 13595

  • Site Reference ID/Investigator# 53090

    Berlin, 14129

  • Site Reference ID/Investigator# 35553

    Berlin, 14163

  • Site Reference ID/Investigator# 57893

    Berlin-Weissensee, 13086

  • Site Reference ID/Investigator# 35555

    Bernau, 16321

  • Site Reference ID/Investigator# 53213

    Bernsbach, 8315

  • Site Reference ID/Investigator# 34274

    Beverungen, 37688

  • Site Reference ID/Investigator# 53085

    Bietigheim-Bissingen, 74321

  • Site Reference ID/Investigator# 53268

    Bietigheim-Bissingen, 74321

  • Site Reference ID/Investigator# 34284

    Blankenburg/Hart, 38889

  • Site Reference ID/Investigator# 34287

    Blaubeuren Abbey, 89143

  • Site Reference ID/Investigator# 34290

    Bocholt, 46399

  • Site Reference ID/Investigator# 35640

    Bochum, 44789

  • Site Reference ID/Investigator# 53196

    Bochum, 44789

  • Site Reference ID/Investigator# 53179

    Bochum, 44791

  • Site Reference ID/Investigator# 57908

    Bochum, 44803

  • Site Reference ID/Investigator# 35643

    Bogen, 94327

  • Site Reference ID/Investigator# 34301

    Bonn, 53111

  • Site Reference ID/Investigator# 34295

    Bonn, 53177

  • Site Reference ID/Investigator# 34306

    Braunschweig, 38100

  • Site Reference ID/Investigator# 53234

    Breitenbrunn, 08359

  • Site Reference ID/Investigator# 35608

    Bremen, 28209

  • Site Reference ID/Investigator# 52987

    Bremen, 28209

  • Site Reference ID/Investigator# 53107

    Bremen, 28209

  • Site Reference ID/Investigator# 53247

    Bremen, 28239

  • Site Reference ID/Investigator# 91073

    Bremerhaven, 27572

  • Site Reference ID/Investigator# 34265

    Buch, 13125

  • Site Reference ID/Investigator# 64291

    Buch, 13125

  • Site Reference ID/Investigator# 68584

    Burgstädt, 09217

  • Site Reference ID/Investigator# 81599

    Chemnitz, 09119

  • Site Reference ID/Investigator# 34698

    Chemnitz, 09126

  • Site Reference ID/Investigator# 57902

    Chemnitz, 9116

  • Site Reference ID/Investigator# 35094

    Chemnitz, D-09130

  • Site Reference ID/Investigator# 53262

    Cologne, 50679

  • Site Reference ID/Investigator# 64298

    Cologne, 50679

  • Site Reference ID/Investigator# 64293

    Cologne, 50733

  • Site Reference ID/Investigator# 33988

    Cologne, 50823

  • Site Reference ID/Investigator# 53193

    Cologne, 50931

  • Site Reference ID/Investigator# 53071

    Cologne, 50937

  • Site Reference ID/Investigator# 35236

    Cologne, 51067

  • Site Reference ID/Investigator# 64300

    Cologne, 51103

  • Site Reference ID/Investigator# 72857

    Cologne, 51109

  • Site Reference ID/Investigator# 34710

    Cottbus, 03046

  • Site Reference ID/Investigator# 53184

    Cottbus, 3048

  • Site Reference ID/Investigator# 64303

    Darmstadt, 64283

  • Site Reference ID/Investigator# 35620

    Darmstadt, 64295

  • Site Reference ID/Investigator# 34724

    Deggendorf, 94469

  • Site Reference ID/Investigator# 53209

    Delmenhorst, 27749

  • Site Reference ID/Investigator# 53089

    Delmenhorst, 27753

  • Site Reference ID/Investigator# 91077

    Dinslaken, 46535

  • Site Reference ID/Investigator# 34741

    Dortmund, 44147

  • Site Reference ID/Investigator# 35637

    Dortmund, 44147

  • Site Reference ID/Investigator# 35633

    Dortmund, 44263

  • Site Reference ID/Investigator# 57899

    Dresden, 01067

  • Site Reference ID/Investigator# 35172

    Dresden, 01097

  • Site Reference ID/Investigator# 34753

    Dresden, 01109

  • Site Reference ID/Investigator# 53069

    Dresden, 01219

  • Site Reference ID/Investigator# 34747

    Dresden, 01277

  • Site Reference ID/Investigator# 34750

    Dresden, 01277

  • Site Reference ID/Investigator# 34759

    Dresden, 01277

  • Site Reference ID/Investigator# 68590

    Dresden, 01277

  • Site Reference ID/Investigator# 53182

    Dresden, 01307

  • Site Reference ID/Investigator# 91081

    Dresden, 1109

  • Site Reference ID/Investigator# 68592

    Dresden, 1217

  • Site Reference ID/Investigator# 57904

    Dresden, 1309

  • Site Reference ID/Investigator# 34777

    Duisburg, 47055

  • Site Reference ID/Investigator# 53072

    Duisburg, 47249

  • Site Reference ID/Investigator# 98537

    Duisburg, 47249

  • Site Reference ID/Investigator# 53266

    Düren, 52349

  • Site Reference ID/Investigator# 34772

    Düsseldorf, 40211

  • Site Reference ID/Investigator# 64302

    Düsseldorf, 40225

  • Site Reference ID/Investigator# 34783

    Eberswalde, 16225

  • Site Reference ID/Investigator# 53194

    Eberswalde, 16225

  • Site Reference ID/Investigator# 53065

    Eisenach, 99817

  • Site Reference ID/Investigator# 72856

    Eisenach, 99817

  • Site Reference ID/Investigator# 53000

    Eisleben Lutherstadt, 06295

  • Site Reference ID/Investigator# 35181

    Elmshorn, 25335

  • Site Reference ID/Investigator# 53114

    Eppstein, 65817

  • Site Reference ID/Investigator# 53221

    Erftstadt, 50374

  • Site Reference ID/Investigator# 53070

    Erfurt, 99084

  • Site Reference ID/Investigator# 53258

    Erfurt, 99084

  • Site Reference ID/Investigator# 53259

    Erfurt, 99084

  • Site Reference ID/Investigator# 57900

    Erfurt, 99084

  • Site Reference ID/Investigator# 34808

    Erfurt, 99096

  • Site Reference ID/Investigator# 35095

    Erfurt, 99096

  • Site Reference ID/Investigator# 57901

    Erkrath, 40699

  • Site Reference ID/Investigator# 34820

    Erlangen, 91056

  • Site Reference ID/Investigator# 57896

    Erlangen, D-91054

  • Site Reference ID/Investigator# 35195

    Essen, 45326

  • Site Reference ID/Investigator# 35198

    Essen, 45356

  • Site Reference ID/Investigator# 53219

    Esslingen am Neckar, 73732

  • Site Reference ID/Investigator# 35201

    Feldafing, 82340

  • Site Reference ID/Investigator# 35204

    Flensburg, 24937

  • Site Reference ID/Investigator# 34832

    Forchheim, 91301

  • Site Reference ID/Investigator# 35209

    Frankenberg, 09669

  • Site Reference ID/Investigator# 64283

    Frankfurt, 60590

  • Site Reference ID/Investigator# 34839

    Frankfurt, 60596

  • Site Reference ID/Investigator# 35212

    Fraureuth, 08427

  • Site Reference ID/Investigator# 91078

    Frechen, 50226

  • Site Reference ID/Investigator# 35218

    Freiberg, 09599

  • Site Reference ID/Investigator# 34853

    Freiburg im Breisgau, 79098

  • Site Reference ID/Investigator# 34856

    Freiburg im Breisgau, 79098

  • Site Reference ID/Investigator# 34860

    Freiburg im Breisgau, 79106

  • Site Reference ID/Investigator# 35100

    Freystadt, 92342

  • Site Reference ID/Investigator# 35223

    Friedrichroda, 99894

  • Site Reference ID/Investigator# 68843

    Garching, 85748

  • Site Reference ID/Investigator# 34878

    Gelsenkirchen, 45881

  • Site Reference ID/Investigator# 68591

    Gelsenkirchen, 45897

  • Site Reference ID/Investigator# 34882

    Gera, 07545

  • Site Reference ID/Investigator# 57907

    Gera, 07545

  • Site Reference ID/Investigator# 64285

    Gera, 07545

  • Site Reference ID/Investigator# 64294

    Gera, 07545

  • Site Reference ID/Investigator# 57897

    Gera, 07548

  • Site Reference ID/Investigator# 53222

    Gera, 7546

  • Site Reference ID/Investigator# 34886

    Giessen, 35392

  • Site Reference ID/Investigator# 53116

    Gornau, 09405

  • Site Reference ID/Investigator# 34895

    Goslar, 38642

  • Site Reference ID/Investigator# 68589

    Gotha, 99867

  • Site Reference ID/Investigator# 52998

    Göttingen, 37075

  • Site Reference ID/Investigator# 35493

    Gräfelfing, 82166

  • Site Reference ID/Investigator# 53224

    Greifswald, 17489

  • Site Reference ID/Investigator# 57889

    Greifswald, 17489

  • Site Reference ID/Investigator# 64289

    Greifswald, 17489

  • Site Reference ID/Investigator# 34903

    Greifswald, 17491

  • Site Reference ID/Investigator# 58122

    Greifswald, 17491

  • Site Reference ID/Investigator# 53106

    Gronau, 48599

  • Site Reference ID/Investigator# 91070

    Großenhain, 01558

  • Site Reference ID/Investigator# 34911

    Güstrow, 18273

  • Site Reference ID/Investigator# 34936

    Halle, 06108

  • Site Reference ID/Investigator# 34939

    Halle, 06108

  • Site Reference ID/Investigator# 53067

    Halle, 06108

  • Site Reference ID/Investigator# 53236

    Halle, 06108

  • Site Reference ID/Investigator# 81601

    Halle, 06108

  • Site Reference ID/Investigator# 34921

    Halle, 06112

  • Site Reference ID/Investigator# 34943

    Halle, 06120

  • Site Reference ID/Investigator# 34931

    Halle, 06128

  • Site Reference ID/Investigator# 53063

    Hamburg, 20144

  • Site Reference ID/Investigator# 53183

    Hamburg, 20246

  • Site Reference ID/Investigator# 96237

    Hamburg, 20246

  • Site Reference ID/Investigator# 34969

    Hamburg, 20251

  • Site Reference ID/Investigator# 53073

    Hamburg, 20354

  • Site Reference ID/Investigator# 34951

    Hamburg, 20355

  • Site Reference ID/Investigator# 53276

    Hamburg, 21031

  • Site Reference ID/Investigator# 34957

    Hamburg, 21075

  • Site Reference ID/Investigator# 96242

    Hamburg, 21109

  • Site Reference ID/Investigator# 35451

    Hamburg, 22081

  • Site Reference ID/Investigator# 53198

    Hamburg, 22081

  • Site Reference ID/Investigator# 35113

    Hamburg, 22087

  • Site Reference ID/Investigator# 35006

    Hamburg, 22089

  • Site Reference ID/Investigator# 53186

    Hamburg, 22089

  • Site Reference ID/Investigator# 53212

    Hamburg, 22111

  • Site Reference ID/Investigator# 53206

    Hamburg, 22119

  • Site Reference ID/Investigator# 34960

    Hamburg, 22147

  • Site Reference ID/Investigator# 53199

    Hamburg, 22147

  • Site Reference ID/Investigator# 35448

    Hamburg, 22179

  • Site Reference ID/Investigator# 34954

    Hamburg, 22415

  • Site Reference ID/Investigator# 34997

    Hamburg, 22459

  • Site Reference ID/Investigator# 34993

    Hamburg, 22523

  • Site Reference ID/Investigator# 53098

    Hamburg, 22529

  • Site Reference ID/Investigator# 53279

    Hamburg, 22529

  • Site Reference ID/Investigator# 72854

    Hamburg, 22607

  • Site Reference ID/Investigator# 34982

    Hamburg, 22609

  • Site Reference ID/Investigator# 34985

    Hamburg, 22609

  • Site Reference ID/Investigator# 35110

    Hamburg, 22609

  • Site Reference ID/Investigator# 53066

    Hamburg, 22609

  • Site Reference ID/Investigator# 53248

    Hamburg, 22761

  • Site Reference ID/Investigator# 34973

    Hamburg, 22767

  • Site Reference ID/Investigator# 35018

    Hanau, 63450

  • Site Reference ID/Investigator# 33711

    Hanover, 30159

  • Site Reference ID/Investigator# 53100

    Hanover, 30159

  • Site Reference ID/Investigator# 68582

    Hanover, 30159

  • Site Reference ID/Investigator# 53083

    Hanover, 30161

  • Site Reference ID/Investigator# 64301

    Hanover, 30625

  • Site Reference ID/Investigator# 34022

    Hansestadt Salzwedel, 29410

  • Site Reference ID/Investigator# 53256

    Harrislee, 24955

  • Site Reference ID/Investigator# 33797

    Heidelberg, 69120

  • Site Reference ID/Investigator# 33804

    Heidelberg, 69120

  • Site Reference ID/Investigator# 35118

    Heidelberg, 69120

  • Site Reference ID/Investigator# 91083

    Heidelberg, 69120

  • Site Reference ID/Investigator# 33800

    Heidelberg, 69121

  • Site Reference ID/Investigator# 33807

    Heidelberg, 69121

  • Site Reference ID/Investigator# 33817

    Heilbad Heiligenstadt, 37308

  • Site Reference ID/Investigator# 53057

    Heilbad Heiligenstadt, 37308

  • Site Reference ID/Investigator# 64297

    Herne, 44623

  • Site Reference ID/Investigator# 57894

    Herrsching am Ammersee, 82211

  • Site Reference ID/Investigator# 68586

    Herten, 45699

  • Site Reference ID/Investigator# 53272

    Hildburghausen, 98646

  • Site Reference ID/Investigator# 53080

    Hilden, 40721

  • Site Reference ID/Investigator# 53097

    Hildesheim, 31124

  • Site Reference ID/Investigator# 33833

    Hof, 95028

  • Site Reference ID/Investigator# 33841

    Hofheim, 65719

  • Site Reference ID/Investigator# 114015

    Hohen Neuendorf, 16540

  • Site Reference ID/Investigator# 33844

    Hohenfelde, 18209

  • Site Reference ID/Investigator# 53084

    Holzkirchen, 83607

  • Site Reference ID/Investigator# 53092

    Homburg, 66424

  • Site Reference ID/Investigator# 91085

    Homburg, 66424

  • Site Reference ID/Investigator# 53109

    Hoyerswerda, 02977

  • Site Reference ID/Investigator# 33857

    Immenstadt im Allgäu, 87509

  • Site Reference ID/Investigator# 98538

    Ingoldstadt, 85049

  • Site Reference ID/Investigator# 33934

    Ingolstadt, 85049

  • Site Reference ID/Investigator# 53111

    Ingolstadt, 85049

  • Site Reference ID/Investigator# 53053

    Jena, 07740

  • Site Reference ID/Investigator# 53055

    Jena, 07743

  • Site Reference ID/Investigator# 5305

    Jena, 07745

  • Site Reference ID/Investigator# 33941

    Jülich, 52428

  • Site Reference ID/Investigator# 33945

    Kahla, 07768

  • Site Reference ID/Investigator# 35123

    Kahla, 07768

  • Site Reference ID/Investigator# 33949

    Kaiserslautern, 67655

  • Site Reference ID/Investigator# 52992

    Kamenz, 01917

  • Site Reference ID/Investigator# 33960

    Karlsruhe, 76133

  • Site Reference ID/Investigator# 35483

    Karlstadt am Main, 97753

  • Site Reference ID/Investigator# 53192

    Kassel, 34117

  • Site Reference ID/Investigator# 33963

    Kassel, 34131

  • Site Reference ID/Investigator# 33967

    Katzhütte, 98746

  • Site Reference ID/Investigator# 53229

    Kiel, 24105

  • Site Reference ID/Investigator# 72859

    Kleinmachnow, 14532

  • Site Reference ID/Investigator# 53233

    Koblenz, 56068

  • Site Reference ID/Investigator# 34001

    Königs Wusterhausen, 15711

  • Site Reference ID/Investigator# 91076

    Krefeld, 47798

  • Site Reference ID/Investigator# 91093

    Krefeld, 47798

  • Site Reference ID/Investigator# 53108

    Krefeld, 47802

  • Site Reference ID/Investigator# 34007

    Kressbronn, 88079

Other trials in Germany

About this study

Official title: A Long Term Documentation to Demonstrate Long Term Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis Under Conditions of Daily Practice

This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.

Read the detailed description

Psoriatic Arthritis participants receiving adalimumab are evaluated in a prospective, non-interventional study (NIS) for 2 years. Patients receive adalimumab 40 mg every other week (eow), per its label. Efficacy and safety parameters are measured routinely at baseline and after 3, 6, 9, 12, 18 and 24 months.

Keywords
Humira, Long-term safety and effectiveness, Psoriatic Arthritis
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01111240
Study groupRoleWhat they receive
Psoriatic ArthritisParticipants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Disease Activity Score (DAS)28

    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

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

  2. Mean Tender Joint Count (TJC) Over Time

    Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.

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

  3. Mean Swollen Joint Count (SJC) Over Time

    Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.

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

  4. Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time

    Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient's hand was equal to 1% BSA.

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

  5. Mean Target Lesion Score (TLS) Over Time

    The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity).

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

  6. Number of Participants With Adverse Events (AEs)

    Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion.

    Measured: Baseline up to 24 months

Secondary outcomes (13)

  1. Number of Participants by Severity of Enthesitis Over Time

    Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.

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

  2. Number of Participants by Severity of Dactylitis Over Time

    Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to "sausage digit," involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.

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

  3. Number of Participants by Severity of Nail Psoriasis Levels Over Time

    Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.

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

  4. Mean Erythrocyte Sedimentation Rate (ESR) Over Time

    The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.

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

  5. Mean C-Reactive Protein (CRP) Levels Over Time

    The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.

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

  6. Patients Global Assessment of Disease Activity Over Time

    Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

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

  7. Participants Assessment of Fatigue Over Time

    Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

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

  8. Participants Assessment of Pain Over Time

    Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

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

  9. Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time

    A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function.

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

  10. Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit

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

  11. Mean Number of Days Missed From Work Due to Psoriatic Arthritis

    Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).

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

  12. Percentage of Participants With In-Patient Hospitalization

    Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).

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

  13. Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication

    Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs

    Measured: Baseline, and Months 6 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2010 (estimated)
  2. Study startAug 2005
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
4,635 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01111240
Sponsor's protocol ID
HUM 05-3
Status last verified
Dec 2014
First submitted
26 Feb 2010
Last updated
30 Dec 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 31311386

  • Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Gnann H, Greger G, Tony HP, Burkhardt H. Minimal disease activity is a stable measure of therapeutic response in psoriatic arthritis patients receiving treatment with adalimumab. Rheumatology (Oxford). 2018 Nov 1;57(11):1938-1946. doi: 10.1093/rheumatology/key203.

    PubMed 30010891

  • Behrens F, Koehm M, Thaci D, Gnann H, Greger G, Maria Wittig B, Burkhardt H. Anti-citrullinated protein antibodies are linked to erosive disease in an observational study of patients with psoriatic arthritis. Rheumatology (Oxford). 2016 Oct;55(10):1791-5. doi: 10.1093/rheumatology/kew229. Epub 2016 Jun 21.

    PubMed 27330166

  • Behrens F, Koehm M, Arndt U, Wittig BM, Greger G, Thaci D, Scharbatke E, Tony HP, Burkhardt H. Does Concomitant Methotrexate with Adalimumab Influence Treatment Outcomes in Patients with Psoriatic Arthritis? Data from a Large Observational Study. J Rheumatol. 2016 Mar;43(3):632-9. doi: 10.3899/jrheum.141596. Epub 2015 Dec 15.

    PubMed 26669916

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott) at 509 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 509 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Disease Activity Score (DAS)28 (time frame: Baseline and Months 3, 6, 9, 12, 18, and 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01111240, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.

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