AzTrials
AzTrials

Moderate to Severe Plaque PsoriasisLOTOSNCT01077232

Documentation of Humira in Psoriasis Patients in Routine Clinical Practice

An observational study of Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 641 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

Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Moderate to Severe Plaque Psoriasis
How many people
5,442 participants
Where
641 sitesGermany
Study dates
4 Jan 2008to 30 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Community Sample: Patients with Plaque Psoriasis

Who may be able to join

  • Moderate to severe plaque psoriasis in adults with no response to other systemic therapy (e.g. cyclosporine, methotrexate or PUVA (photochemical therapy)) or patients with a contraindication or hypersensitivity to such a therapy

Who cannot join

  • 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

Trial locations and contacts

641 sites in 1 country.

300 sites in 1 country

Germany300 sites

  • Praxis M. Vilic /ID# 210108

    Aachen, North Rhine-Westphalia, 52062

  • Universitaetsklinikum Aachen /ID# 35037

    Aachen, North Rhine-Westphalia, 52074

  • Hoeller-Obrigkeit, Aachen, DE /ID# 60599

    Aachen, 52064

  • Petri, Ahaus, DE /ID# 53712

    Ahaus, 48683

  • Gewiss, Ahrensburg, DE /ID# 33431

    Ahrensburg, 22926

  • Praxis Dr. Schuessler /ID# 149404

    Alsfeld, 36304

  • Oster-Schmidt, Altenkirchen, D /ID# 126022

    Altenkirchen, 57610

  • Weiss, Amberg, DE /ID# 60613

    Amberg, 92224

  • Dietz, Ampfing, DE /ID# 50790

    Ampfing, 84539

  • Bell, Andernach, DE /ID# 99815

    Andernach, 56626

  • Schulz, Angermuende, DE /ID# 53719

    Angermünde, 16278

  • Rebbien, Annaberg-Buchholz, DE /ID# 35052

    Annaberg-Buchholz, 9456

  • Thieme, Artern, DE /ID# 35518

    Artern, 06556

  • Dr. Szlava Fuezesi, Achaffenbu /ID# 118537

    Aschaffenburg, 63739

  • Theuring, Aschersleben, DE /ID# 35058

    Aschersleben, 06449

  • Hums, Aue, DE /ID# 60601

    Aue, 08280

  • Gerloff-Steiner, Aue, DE /ID# 53694

    Aue, 8280

  • Schneider & Sedlmayr, Augsburg /ID# 33351

    Augsburg, 86167

  • Lechner/Stuebich, Aurich, DE /ID# 33355

    Aurich, 26603

  • Lechner/Stuebich, Aurich, DE /ID# 67967

    Aurich, 26603

  • Brautzsch, Bad Berka, DE /ID# 33365

    Bad Berka, 99438

  • Broschewitz/Hammer Bad Doberan /ID# 60596

    Bad Doberan, 19209

  • Broschewitz/Hammer Bad Doberan /ID# 67948

    Bad Doberan, 19209

  • Mauer, Bad Kreuznach, DE /ID# 126019

    Bad Kreuznach, 55543

  • Schulz, Bad Muender, DE /ID# 48469

    Bad Münder am Deister, 31848

  • SALUS-Klinik /ID# 33405

    Bad Reichenhall, 83435

  • Praxis Dr. Bock /ID# 166127

    Bad Rothenfelde, 49214

  • Houda, Bad Schlema, DE /ID# 35584

    Bad Schlema, 8301

  • Moerstedt, Bad Woerishofen, DE /ID# 99844

    Bad Wörishofen, 86825

  • Sozialstiftung Bamberg /ID# 33430

    Bamberg, 96049

  • Stephan-Dahm, Bargteheide, DE /ID# 50861

    Bargteheide, 22941

  • Dr. Roxana Homolka, Baunatal, /ID# 118539

    Baunatal, 34225

  • Mirtschink, Bautzen, DE /ID# 50851

    Bautzen, 02625

  • Graessel, Bayreuth, DE /ID# 35587

    Bayreuth, 95444

  • Kinateder, Bayreuth, DE /ID# 33439

    Bayreuth, 95444

  • Blaese & Walther, Bendorf, DE /ID# 50787

    Bendorf, 56170

  • Pflieger-Bruss, Benndorf, DE /ID# 53713

    Benndorf, 56170

  • Timmel/Timm/Vorwerk, Bergen /ID# 33451

    Bergen, 18528

  • Wirtler, Bergisch Gladbach, DE /ID# 33452

    Bergisch Gladbach, 51465

  • Charité Universitätsmedizin Campus Mitte /ID# 33457

    Berlin, 10117

  • Hasert & Hasert, Berlin, DE /ID# 35531

    Berlin, 10117

  • Kindler, Berlin, Germany /ID# 60604

    Berlin, 10117

  • Klusmann, Berlin, DE /ID# 90974

    Berlin, 10117

  • Spickermann, Berlin, DE /ID# 33675

    Berlin, 10247

  • Praxis Dermatologie am Savigny /ID# 145783

    Berlin, 10623

  • Herzler & Reupke, Berlin, DE /ID# 33705

    Berlin, 10627

  • Boodstein, Berlin, Germany /ID# 48417

    Berlin, 10783

  • Rothhaar, Berlin, DE /ID# 33644

    Berlin, 10783

  • Simon, Berlin, DE /ID# 33678

    Berlin, 10827

  • Steinhoff-Georgieva, Berlin,DE /ID# 60612

    Berlin, 10827

  • Struss, Berlin, DE /ID# 33680

    Berlin, 10967

  • Miller/Nerenheim, Berlin, DE /ID# 99842

    Berlin, 12157

  • Praxis Dr. med. Meljanac /ID# 151477

    Berlin, 12159

  • Praxis Dr. med. Meljanac /ID# 35594

    Berlin, 12159

  • Jacob, Berlin, DE /ID# 48438

    Berlin, 12163

  • Vivantes Klinikum Neukolln /ID# 34270

    Berlin, 12351

  • Weihe/Stavermann, Berlin, DE /ID# 35547

    Berlin, 12353

  • Gellrich, Berlin, DE /ID# 33691

    Berlin, 12437

  • Schirmer, Berlin, DE /ID# 35534

    Berlin, 12489

  • Skarabis/Skarabis, Berlin, DE /ID# 34241

    Berlin, 12587

  • Kv Be /Id# 34253

    Berlin, 12689

  • Praxis Dres. Eicholtz/Boerner /ID# 167676

    Berlin, 13051

  • Wildfeuer, Berlin, DE /ID# 33694

    Berlin, 13055

  • Kors, Berlin, DE /ID# 33649

    Berlin, 13086

  • Zahn, Berlin, DE /ID# 35592

    Berlin, 13187

  • Praxis Dr. Uhl /ID# 171308

    Berlin, 13439

  • Dues/Manasterski, Berlin, DE /ID# 35538

    Berlin, 13507

  • Miehe & Partner, Berlin, DE /ID# 166125

    Berlin, 13507

  • Miehe & Partner, Berlin, DE /ID# 35544

    Berlin, 13507

  • Baumann, Berlin, DE /ID# 60584

    Berlin, 13593

  • Groene, Berlin, DE /ID# 60594

    Berlin, 14052

  • Neumann, Bernau, DE /ID# 34271

    Bernau, 16321

  • Praxis Dr. Duhn /ID# 167672

    Bernau bei Berlin, 16321

  • Biel, Bielefeld, DE /ID# 60586

    Bielefeld, 33602

  • MVZ Otto-Brenner-Straße /ID# 167677

    Bielefeld, 33607

  • Staedt Kliniken Bielefeld /ID# 35558

    Bielefeld, 33647

  • Dabour & Dabour, Birkenwerder /ID# 34280

    Birkenwerder, 16547

  • Wege & Kuehnast, Bitterfeld /ID# 34282

    Bitterfeld-Wolfen, 6749

  • Praxis fuer Innere Medizin/Rhe /ID# 35564

    Blaubeuren Abbey, 89143

  • Ruppert, Bocholt, DE /ID# 108918

    Bocholt, 46397

  • Klinikum Ruhr Univ Bochum /ID# 35091

    Bochum, 44791

  • GP Dr. Niesman & Dr. Othlingha /ID# 169694

    Bochum, 44793

  • Ardabili/Niesmann, Bochum, DE /ID# 50784

    Bochum, 44803

  • Universitaetsklinikum Bonn /ID# 34299

    Bonn, 53113

  • Praxis Dr. Schift /ID# 141549

    Borken, 46325

  • Barth, Borna, DE /ID# 35650

    Borna, 04552

  • Barth, Borna, DE /ID# 67946

    Borna, 04552

  • Alte Apotheke /ID# 48530

    Bottrop, 46236

  • Flont-Schmeling, Bottrop, DE /ID# 48423

    Bottrop, 46236

  • Karpinski, Bottrop, DE /ID# 34303

    Bottrop, 46236

  • Tolzin, Brake, DE /ID# 50866

    Brake, 26919

  • Klee/Wolff, Brandenburg, DE /ID# 67960

    Brandenburg, 14776

  • Praxis S. Osadtschy /ID# 161167

    Brandenburg an der Havel, 14770

  • Atugoda, Braunschweig, DE /ID# 48509

    Braunschweig, 38100

  • Gaedt, Braunschweig, DE /ID# 67954

    Braunschweig, 38100

  • Koehn & Ramaker-Brunke, DE /ID# 34309

    Braunschweig, 38114

  • Klinikverbund Bremen /ID# 171306

    Bremen, 28205

  • Elsner, Bremen, DE /ID# 48422

    Bremen, 28209

  • Derma am Diako /ID# 166131

    Bremen, 28239

  • Hermann/Teichelmann, Bremen,DE /ID# 35605

    Bremen, 28239

  • Altvater/Tauschke, Bremen, DE /ID# 34311

    Bremen, 28259

  • Schwichtenberg, Bremen, DE /ID# 34312

    Bremen, 28779

  • Friedmann, Bremerhaven, DE /ID# 67952

    Bremerhaven, 27570

  • Heitmann, Bremerhaven, DE /ID# 148410

    Bremerhaven, 27572

  • Bessle, Buchholz, DE /ID# 60585

    Buchholz, 21244

  • Streit, Buchholz, DE /ID# 53723

    Buchholz I.D. Nordheide, 21244

  • Arensmeier-Gottschalkson, Burg /ID# 48508

    Burg, 39288

  • Praxis K. Neubert /ID# 149400

    Burgstädt, 09217

  • Wagenpfeil, Burscheid, DE /ID# 99856

    Burscheid, 51399

  • Elbe Klinikum Buxtehude /ID# 34694

    Buxtehude, 21614

  • Praxis B. Jaeckel /ID# 145768

    Chemnitz, 09116

  • Jaeckel & Partner, Chemnitz, D /ID# 34703

    Chemnitz, 09119

  • Kuehn/Stengel, Chemnitz, DE /ID# 90978

    Chemnitz, 09123

  • Praxis P. Hausler-Mehlhorn /ID# 149285

    Chemnitz, 09130

  • Schneider, Chemnitz, DE /ID# 35613

    Chemnitz, 9116

  • Hoffmann, Coburg, DE /ID# 34704

    Coburg, 96450

  • Pappai, Coesfeld, DE /ID# 108917

    Coesfeld, 48653

  • Uniklinik Koln /ID# 166128

    Cologne, North Rhine-Westphalia, 50937

  • Karger/Rezazadegan, Cologne DE /ID# 60608

    Cologne, 50679

  • Menge & Franckson, Cologne, DE /ID# 53708

    Cologne, 50733

  • Haitas-Haase, Cologne, DE /ID# 53696

    Cologne, 50935

  • Haase & Partner, Cologne, DE /ID# 53724

    Cologne, 50969

  • Praxis Dres. Neuhaus/Sacha /ID# 149403

    Cologne, 51103

  • Matias-Bako/Krickeberg,Cologne /ID# 90975

    Cologne, 51109

  • Eichhorn, Cologne, DE /ID# 99818

    Cologne, 51143

  • Krebs, Coswig, DE /ID# 48519

    Coswig, 01640

  • Praxis S.-K. Strenzke /ID# 145781

    Cottbus, 03046

  • Dr. Bernd Jantsch, Cottbus, DE /ID# 35618

    Cottbus, 3046

  • Loessner, Cottbus, DE /ID# 34712

    Cottbus, 3046

  • Dr. Susanne Jantsch,Cottbus,DE /ID# 35619

    Cottbus, 3048

  • Klinikum Darmstadt GmbH /ID# 34720

    Darmstadt, 64297

  • Buelow, Delmenhorst, DE /ID# 35626

    Delmenhorst, 27749

  • Thelen, Delmenhorst, DE /ID# 35628

    Delmenhorst, 27753

  • Heidlas, Dessau-Rosslau, DE /ID# 34730

    Dessau, 6842

  • Klinikum Lippe Detmold GmbH /ID# 34731

    Detmold, 32756

  • Friedrich, Dieburg, DE /ID# 53693

    Dieburg, 64807

  • Gerharz, Diez, DE /ID# 48432

    Diez, 65582

  • Winter, Dinkelsbuehl, DE /ID# 34734

    Dinkelsbühl, 91550

  • Ghassem-Zadeh/Farashahi /ID# 138188

    Dormagen, 41539

  • Thomas, Dorsten, DE /ID# 34736

    Dorsten, 46282

  • Brinkmeier & Partner, Dortmund /ID# 138259

    Dortmund, 44137

  • Brinkmeier & Partner, Dortmund /ID# 99847

    Dortmund, 44137

  • Hautklinik Dortmund /ID# 72019

    Dortmund, 44137

  • Hirschmueller, Dortmund, DE /ID# 34737

    Dortmund, 44287

  • Bebnowski, Dortmund, DE /ID# 53684

    Dortmund, 44309

  • Dick/Hubert/Mirkin, Dortmund /ID# 99843

    Dortmund, 44369

  • Frolova, Dortmund, DE /ID# 51022

    Dortmund, 44388

  • Praxis Dr. Büchner /ID# 204352

    Dresden, Saxony, 01307

  • Frach/Hohaus, Dresden, DE /ID# 35166

    Dresden, 01067

  • Frach/Hohaus, Dresden, DE /ID# 60600

    Dresden, 01067

  • Gerlach, Dresden, DE /ID# 48433

    Dresden, 01097

  • Praxis Dres. Pollack Schramm /ID# 149286

    Dresden, 01097

  • Kuehn, Dresden, DE /ID# 34752

    Dresden, 01109

  • Schamfuss, Dresden, DE /ID# 48468

    Dresden, 01159

  • Richter-Huhn, Dresden, DE /ID# 35164

    Dresden, 01219

  • Hass, Dresden, Germany /ID# 60597

    Dresden, 01279

  • Meier, Dresden, DE /ID# 48452

    Dresden, 01307

  • Universitaetklinikum Dresden /ID# 34764

    Dresden, 01307

  • University Clinic Carl Gustav /ID# 99820

    Dresden, 01307

  • Praxis Dr. Mayer /ID# 148243

    Dresden, 01309

  • Scheibner, Dresden, DE /ID# 35162

    Dresden, 1217

  • Oppers, Dresden, DE /ID# 126021

    Dresden, 1277

  • Siebert, Duisburg, DE /ID# 34775

    Duisburg, 47166

  • St. Barbara-Hospital /ID# 81302

    Duisburg, 47167

  • Praxis. Y. Teoman /ID# 142005

    Duisburg, 47179

  • Elsner, Duisburg, DE /ID# 99819

    Duisburg, 47239

  • Saget & Riesopp, Duisburg, DE /ID# 35175

    Duisburg, 47249

  • Praxis Dr. Lobert /ID# 145774

    Duisburg, 47259

  • Bockhorst & Dominicus, Duelmen /ID# 34765

    Dülmen, 48249

  • Korge, Dueren, DE /ID# 35174

    Düren, 52349

  • Evangelisches Krankenhaus Dues /ID# 48419

    Düsseldorf, 40217

  • Berendt, Eberswalde, DE /ID# 35178

    Eberswalde, 16225

  • Badura, Eilenburg, DE /ID# 35179

    Eilenburg, 4838

  • Praxis Dr. Kues /ID# 145771

    Einbeck, 37574

  • Dove, Eisenach, DE /ID# 48420

    Eisenach, 99817

  • Reinhardt, Eisenach, DE /ID# 48465

    Eisenach, 99817

  • Rast, Eisenhuettenstadt, DE /ID# 34789

    Eisenhüttenstadt, 15890

  • Richter/Cyw, Eisenhuettenstadt /ID# 34790

    Eisenhüttenstadt, 15890

  • Noack, Lutherstadt Eisleben,DE /ID# 48521

    Eisleben Lutherstadt, 06295

  • Schmid, Ellwangen, DE /ID# 34792

    Ellwangen, 73479

  • Praxis Dr. Fitz /ID# 145767

    Elmshorn, 25337

  • Hartl, Eltville, DE /ID# 34796

    Eltville, 65343

  • Med X Aerzteteam GmbH /ID# 90977

    Emden, 26721

  • Meinert, Emden, DE /ID# 34797

    Emden, 26721

  • Maurer & Krebs-Posingies /ID# 34800

    Emsdetten, 48282

  • Schurhammer-Fuhrmann, Endingen /ID# 67966

    Endingen, 79346

  • Koenig, Erfurg, DE /ID# 99838

    Erfurt, 99084

  • Nennstiel, Erfurt, DE /ID# 34804

    Erfurt, 99091

  • Universitaetsklinikum Erlangen /ID# 34816

    Erlangen, Bavaria, 91054

  • Lichtenstein, Eschweiler, DE /ID# 50842

    Eschweiler, 52249

  • Praxis Dres. Exner/Kanja /ID# 145769

    Essen, 45147

  • Universitaetsklinikum Essen /ID# 34827

    Essen, 45147

  • Universitaetsklinikum Essen /ID# 53718

    Essen, 45147

  • Klundt, Essen, DE /ID# 138195

    Essen, 45327

  • Praxis Dres. Beyer /ID# 141989

    Essen, 45329

  • Praxis Dres. Beyer /ID# 90957

    Essen, 45329

  • Praxis Dr. Porwollik /ID# 148244

    Essen, 45355

  • Praxis Dres. Renner/Sohl /ID# 149289

    Esslingen am Neckar, 73728

  • Huerkamp, Euskirchen, DE /ID# 48517

    Euskirchen, 53879

  • Swirski, Euskirchen, DE /ID# 81314

    Euskirchen, 53879

  • Praxis Dres. Freitag/Knoell /ID# 167675

    Falkensee, 14612

  • Jovic-Paris, Bad Neuenahr /ID# 48439

    Fitzroy, 3065

  • Godt, Flensburg, DE /ID# 67957

    Flensburg, 24939

  • Praxis T. Zimmermann /ID# 145784

    Flöha, 09557

  • Eichinger, Frankenberg, DE /ID# 138260

    Frankenberg, 09669

  • Schoengen/Schwarzenbach, Frank /ID# 60610

    Frankenthal, 67227

  • Schoengen/Schwarzenbach, Frank /ID# 60611

    Frankenthal, 67227

  • Kaufmann, Frankfurt, DE /ID# 35098

    Frankfurt, 60596

  • Universitätsklinikum Frankfurt /ID# 53725

    Frankfurt am Main, Hesse, 60590

  • Hundgeburth, Frechen, DE /ID# 138192

    Frechen, 50226

  • Kaemmerer, Freiberg, DE /ID# 138194

    Freiberg, 09599

  • Trefzer, Freiburg im Breisgau, /ID# 126028

    Freiburg im Breisgau, 79098

  • Kurzen, Freising, DE /ID# 67964

    Freising, 85354

  • Schmidt, Fuerstenwalde, DE /ID# 34868

    Fürstenwalde, 15517

  • Gall, Fuerth, DE /ID# 48431

    Fürth, 90762

  • Teichler, Gaggenau, DE /ID# 99855

    Gaggenau, 76571

  • Wolf, Garbsen, DE /ID# 99859

    Garbsen, 30823

  • Praxis Dr. Billmann-Krutmann /ID# 149399

    Geilenkirchen, 52511

  • Praxis Dres. Kobus / Wetz /ID# 169692

    Gelsenkirchen, 45886

  • Praxis K. R. Koerber & Partner /ID# 151715

    Gelsenkirchen, 45894

  • Wetz, Gelsenkirchen, DE /ID# 99858

    Gelsenkirchen, 45894

  • Rotterdam, Gelsenkirchen, DE /ID# 50856

    Gelsenkirchen, 45897

  • Praxis J. Teichmann & Partner /ID# 145775

    Gelsenkirchen, 45899

  • Lange, Dietrich & Beyer, Gera /ID# 48449

    Gera, 07545

  • Lange, Dietrich & Beyer, Gera /ID# 81274

    Gera, 07545

  • Paul/Meyer, Gera, DE /ID# 54379

    Gera, 07545

  • SRH Wald-Klinikum Gera GmbH /ID# 60602

    Gera, 07548

  • Schnee, Gera, DE /ID# 81313

    Gera, 07549

  • Estel, Gera, DE /ID# 35226

    Gera, 7546

  • Loth, Gernsbach, DE /ID# 50844

    Gernsbach, 76593

  • Gross/Braeu, Giessen, DE /ID# 34884

    Giessen, 35390

  • Kloevekorn & Tepe, Gilching /ID# 118541

    Gilching, 82205

  • Kloevekorn & Tepe, Gilching /ID# 48504

    Gilching, 82205

  • Kloevekorn & Tepe, Gilching /ID# 48506

    Gilching, 82205

  • Brinkmann & Partner, Gladbeck, /ID# 34889

    Gladbeck, 45964

  • Brinkmann & Partner, Gladbeck, /ID# 53688

    Gladbeck, 45964

  • Jahn, Glauchau, DE /ID# 35230

    Glauchau, 8371

  • Hille, Goerlitz, DE /ID# 60598

    Görlitz, 02826

  • Cleffmann/Ranke, Goettingen DE /ID# 53689

    Göttingen, 37073

  • Univ Medical Center Goettingen /ID# 35103

    Göttingen, 37075

  • Kisslinger/Kisslinger, Grafena /ID# 34897

    Grafenau, 94481

  • Kuckert, Graefenhainichen, DE /ID# 48520

    Gräfenhainichen, 06773

  • Herrmann, Greifswald, DE /ID# 72016

    Greifswald, 17489

  • Manke, Grevesmuehlen, DE /ID# 34907

    Grevesmühlen, 23936

  • Wigbels, Gronau, DE /ID# 48505

    Gronau, 48599

  • Grossmann, Grossenhain, DE /ID# 126016

    Großenhain, 01558

  • Westphal, Guestrow, DE /ID# 35500

    Güstrow, 18273

  • Busse-Misic, Hagen, DE /ID# 34914

    Hagen, 58095

  • Timtschenko, Hagen, DE /ID# 138203

    Hagen, 58095

  • Stehl, Haiger, DE /ID# 126027

    Haiger, 35708

  • Gstoettner, Halle, DE /ID# 48513

    Halle, 01632

  • Hamm, Halle, DE /ID# 72015

    Halle, 06108

  • Lutze, Halle, DE /ID# 34919

    Halle, 06108

  • Reiss, Halle, DE /ID# 35507

    Halle, 06108

  • Zarzour, Halle, DE /ID# 35505

    Halle, 06108

  • Hetschko, Halle, DE /ID# 48437

    Halle, 06114

  • Universitatsklinikum Halle /ID# 34941

    Halle, 6120

  • Gagu-Koll, Hamburg, DE /ID# 48424

    Hamburg, 20148

  • Univ Klinik Eppendorf Hamburg /ID# 35115

    Hamburg, 20246

  • Univ Klinik Eppendorf Hamburg /ID# 48453

    Hamburg, 20246

  • Dermatologikum Hamburg /ID# 35107

    Hamburg, 20354

  • Wagner, Hamburg, DE /ID# 99857

    Hamburg, 20354

  • Mengert/Nienstedt, Hamburg, DE /ID# 34995

    Hamburg, 21073

  • Luetten, Hamburg, DE /ID# 50847

    Hamburg, 21109

  • Kahle/Ohnemus, Hamburg, DE /ID# 148412

    Hamburg, 22041

  • Praxis Dres. Harms/Hartmann /ID# 148249

    Hamburg, 22049

  • Buerger, Hamburg, DE /ID# 34966

    Hamburg, 22111

  • Montag, Hamburg, DE /ID# 35438

    Hamburg, 22143

  • Buck, Hamburg, DE /ID# 34964

    Hamburg, 22305

  • Dermatologisches Ambulatorium /ID# 35435

    Hamburg, 22391

  • Dermatologisches Ambulatorium /ID# 35436

    Hamburg, 22391

  • Kunze, Hamburg, DE /ID# 34949

    Hamburg, 22457

  • Kuwert/Wendt/Schulz, Hamburg, /ID# 34991

    Hamburg, 22457

  • Hautarztpraxis am Tibarg /ID# 35004

    Hamburg, 22459

  • Schmolke, Hamburg, DE /ID# 67965

    Hamburg, 22523

  • Wrage-Brors, Hamburg, DE /ID# 126030

    Hamburg, 22587

  • Szabo, Hamm, DE /ID# 35015

    Hamm, 59065

  • Weitzel, Hamm, DE /ID# 90982

    Hamm, 59065

  • Klinikum Hanau gGmbH /ID# 35020

    Hanau, 63450

  • Praxis U. Stein /ID# 171307

    Hanover, 30159

  • Theuerkauf, Hanover, DE /ID# 35454

    Hanover, 30159

  • Stein, Hanover, DE /ID# 35029

    Hanover, 30167

  • Horstmann, Hanover, DE /ID# 35026

    Hanover, 30625

  • Universitaetsklinik Heidelberg /ID# 33810

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinik Heidelberg /ID# 50858

    Heidelberg, Baden-Wurttemberg, 69120

  • Durani & Durani, Heidelberg,DE /ID# 48421

    Heidelberg, 69115

  • Alheit, Heidenau, DE /ID# 50782

    Heidenau, 01809

  • Pawlak, Heilbad Heiligenstadt, /ID# 138191

    Heilbad Heiligenstadt, 37308

  • Pawlak, Heilbad Heiligenstadt, /ID# 35466

    Heilbad Heiligenstadt, 37308

  • Arnold/Kaschubowski/Salzer/Wur /ID# 67971

    Heilbronn, 74072

  • Arnold/Kaschubowski/Salzer/Wur /ID# 99837

    Heilbronn, 74072

  • Schulte/Mainusch, Heiligenhaus /ID# 138202

    Heiligenhaus, 42579

  • Postrach, Hennigsdorf, DE /ID# 35468

    Hennigsdorf, 16761

  • Praxis G. Taesler /ID# 145782

    Herrnhut, 02747

  • Allmacher, Hersbruck, DE /ID# 125998

    Hersbruck, 91217

  • PsoriSol Hautklinik GmbH /ID# 169690

    Hersbruck, 91217

  • Kroemer, Herten, DE /ID# 48448

    Herten, 45699

  • Badacz, Heusenstamm, DE /ID# 125999

    Heusenstamm, 63150

  • Biedenkapp, Heusenstamm, DE /ID# 81275

    Heusenstamm, 63150

  • Stark & Stark, Hilden, DE /ID# 35470

    Hilden, 40721

Other trials in Germany

About this study

Official title: Long Term Documentation of the Safety and Efficacy as Well as the Effects on Work Productivity in Patients With Moderate to Severe Plaque Psoriasis Treated With HUMIRA (Adalimumab) in Routine Clinical Practice (LOTOS)

Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.

Read the detailed description

Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice. The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of:

  • the number of missed working days
  • the number of visits to doctor's office
  • the number and duration of hospitalizations
  • work ability to assess efficacy for different subgroups by
  • the number of patients achieving a PASI 75 response to evaluate safety by
  • the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease
Keywords
Moderate to Severe Plaque Psoriasis, Humira, Safety, Efficacy, Work Productivity

What participants receive

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

Study groups in NCT01077232
Study groupRoleWhat they receive
Psoriasis PatientsPatients with moderate to severe plaque psoriasis

What is being measured

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

  1. Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction.

    Measured: At 24, 48 and 60 months

  2. Changes in healthcare parameters: number of missed working days due to psoriasis; number of visits at the doctor's office; number and duration of hospitalizations, self-assessed workability.

    Measured: At 24, 48 and 60 months

  3. Safety and tolerability assessed by analyzing serious and non-serous adverse events.

    Measured: At 24, 48 and 60 months

Secondary outcomes (7)

  1. Global physician's assessment on Humira treatment.

    Measured: At 24, 48 and 60 months

  2. Target Nail Psoriasis Severity Index (target NAPSI).

    Measured: At 24 months

  3. Itch Visual Analogue Scale (Itch VAS).

    Measured: At 24 months

  4. Safety and tolerability of Humira - treatment for patient groups with frequent concommitant diseases, especially diabetes type I and II, cardio-vascular and liver and kidney functional impairment and respective concommitant medication.

    Measured: At 24, 48 and 60 months

  5. Palmoplantar Psoriasis Area Severity Index (pPASI).

    Measured: At 24 months

  6. Influence of body mass index and weight on efficacy measurement.

    Measured: At 24, 48 and 60 months

  7. Patients' assessment on Humira treatment.

    Measured: At 24, 48 and 60 months

Timeline

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

  1. First posted1 Mar 2010 (estimated)
  2. Study start4 Jan 2008
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

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
5,442 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01077232
Sponsor's protocol ID
P10-446
Acronym
LOTOS
Status last verified
Jun 2020
First submitted
25 Feb 2010
Last updated
12 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 641 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 1 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 641 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction. (time frame: At 24, 48 and 60 months). The study lists 3 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 NCT01077232.

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 12 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in