A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

NCT ID: NCT02486302

Last Updated: 2019-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1534 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-24
• Study Completion Date: 2017-12-11

Brief Summary

The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis; Plaque Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation Group

Etanercept

Intervention Type: DRUG

Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.

Interventions

Etanercept

Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of RA, axSpA, PsA or PsO
• No prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics.

Exclusion Criteria

• The contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply.
• The additional documentation of the patient in another post-marketing study with etanercept is not permitted.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Rheumatologisches MVZ Dresden GmbH im Gesundheitszentrum Dresden - Klotzsche (GZDK)

Dresden, Saxony, Germany

private practise Hemmerich

Aachen, , Germany

private practise Kurthen

Aachen, , Germany

Gesundheits- und Pflegezentrum Alsfeld gGmbH

Alsfeld, , Germany

private practise Kupka

Altenburg, , Germany

Private Practise Boehm

Altenholz, , Germany

Private Practise Marycz

Amberg, , Germany

Klinikum Bad Bramstedt

Bad Bramstedt, , Germany

private practise Gause

Bad Bramstedt, , Germany

private practise Messis

Bad Homburg, , Germany

ACURA Rheumazentrum Bad Kreuznach

Bad Kreuznach, , Germany

private practise Hesse

Bad Kreuznach, , Germany

private practise Manger

Bamberg, , Germany

private practise Balzer

Bautzen, , Germany

private practise Winkler

Bautzen, , Germany

private practise Ochs

Bayreuth, , Germany

private practise Schmitt-Haendle

Bayreuth, , Germany

Charité Berlin Rheumatologie und Klinische Immunologie

Berlin, , Germany

Med. Versorgungszentrum Ambulantes Gesundheitszentrum Charite Campus Mitte

Berlin, , Germany

private practise Hasert

Berlin, , Germany

Praxis Roßbacher

Berlin, , Germany

private practise Bozorg

Berlin, , Germany

private practise Brandt-Jürgens

Berlin, , Germany

private practise Herzberg

Berlin, , Germany

private practise Remstedt

Berlin, , Germany

private practise Seifert

Berlin, , Germany

private practise Zinke

Berlin, , Germany

private practise Kors

Berlin, , Germany

Rheumaklinik Berlin-Buch

Berlin, , Germany

private practise Miehe

Berlin, , Germany

private practise Schnorfeil

Berlin, , Germany

private practise Koelnberger

Bogen, , Germany

private practise Barth

Borna, , Germany

private practise Eisterhues

Braunschweig, , Germany

Private Practise Ramaker-Brunke

Braunschweig, , Germany

private practise Mall

Bremen, , Germany

private practise Schwichtenberg

Bremen, , Germany

Private Practise Wagener

Bruchhausen-Vilsen, , Germany

private practise Feuchtenberger

Burghausen, , Germany

private practise Budde

Bückeburg, , Germany

Mvz Agliomed

Chemnitz, , Germany

private practise Schneider

Chemnitz, , Germany

private practise Wilden

Cologne, , Germany

Office of Parysa Alborz, MD

Cologne, , Germany

private practise Geißler

Cottbus, , Germany

private practise Kirrstetter

Deggendorf, , Germany

Kreiskrankenhaus Demmin GmbH

Demmin, , Germany

private practise Heidlas

Dessau, , Germany

private practise Bebnowski

Dortmund, , Germany

private practise Gerlach

Dresden, , Germany

private practise Lüthke

Dresden, , Germany

private practise Fischer

Dresden, , Germany

private practise Oppers

Dresden, , Germany

private practise Roch

Dresden, , Germany

private practise Fendler

Duisburg, , Germany

private practise Riesopp

Duisburg, , Germany

private practise Strothmeyer

Düsseldorf, , Germany

Bezirksklinikum Obermain

Ebensfeld, , Germany

private practise Berendt

Eberswalde, , Germany

private practise Pech

Eberswalde, , Germany

Asklepios MVZ Nord SH GmbH, c/o AK St. Georg

Elmshorn, , Germany

Elbe Elster MVZ GmbH

Elsterwerda, , Germany

MVZ Kaestner + Kaestner GbR

Erfurt, , Germany

private practise Koch

Erfurt, , Germany

Universitaetsklinikum Essen, Klinik fuer Dermatologie

Essen, , Germany

private practise Freitag

Falkensee, , Germany

private practise Häckel

Frankenberg, , Germany

private practise Fritzsch

Frankfurt, , Germany

Klinikum der J.W. Goethe-Universität, Klinik für Dermatologie, Klinische Forschung

Frankfurt am Main, , Germany

private practise Höhne

Fraureuth, , Germany

private practise Müller

Freiberg, , Germany

private practise Behringer

Fulda, , Germany

private practise Bussmann

Geilenkirchen, , Germany

private practise Zeh

Geislingen A.d. Steige, , Germany

Private Practice Abahji

Germering, , Germany

Private Practise

Giessen, , Germany

Praxis Dres. Dr.Brinkmann, Schult, Samimi-Fard

Gladbeck, , Germany

private practise Schumann

Groß Reken, , Germany

private practise Kühne

Haldensleben I, , Germany

private practise Liebhaber

Halle, , Germany

MVZ Rheumatologie und Autoimmunmedizin GmbH

Hamburg, , Germany

MVZ Nord GmbH

Hamburg, , Germany

Katholisches Marienkrankenhaus Geriatrische Klinik

Hamburg, , Germany

Private Practise Höhle

Hamburg, , Germany

private practise Dahmen

Hamburg, , Germany

private practise Weinhardt

Hamburg, , Germany

private practise Aries

Hamburg, , Germany

Praxis Praxis Dr. Szabo & Kollegen

Hamm, , Germany

Private Practise Stille

Hanover, , Germany

private practise Stein

Hanover, , Germany

private practise Heilig

Heidelberg, , Germany

private practise Lassak-Siedl

Heidelberg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

private Practise Pawlak

Heilbad Heiligenstadt, , Germany

private practise Schleußner

Heilbad Heiligenstadt, , Germany

private practise Thies

Herrsching am Ammersee, , Germany

private practise Meier

Hofheim, , Germany

private practise Wernicke

Hohen Neuendorf, , Germany

Private Practice Streibl

Holzkirchen, , Germany

private practise Kapelle

Hoyerswerda, , Germany

Uniklinik Jena

Jena, , Germany

Private Practise Kremers

Jülich, , Germany

private practise Bräunig

Kahla, , Germany

Praxis Mauer

Kamenz, , Germany

Private Practise Turin

Karlstadt am Main, , Germany

private practise Schwab

Kiel, , Germany

private practise Merkel

Königs Wusterhausen, , Germany

private practise Straub

Kronach, , Germany

Kreiskrankenhaus Langenau

Langenau, , Germany

Boche-Hamann-Teich

Leipzig, , Germany

private practise Schwarze

Leipzig, , Germany

private practise Zeiger

Leipzig, , Germany

private practise Wiemers

Leipzig, , Germany

private practise Weiß

Lichtenstein, , Germany

private practise Holst

Ludwigslust, , Germany

Private Practise Legler

Lübeck, , Germany

private practise Kudela

Magdeburg, , Germany

private practise Raschke

Magdeburg, , Germany

private practise Sieburg

Magdeburg, , Germany

private practise Weimann

Magdeburg, , Germany

Hautklinik der Universitätsmedizin Mainz KöR,Clinical Research Center

Mainz, , Germany

private practise Zimmermann

Malchow, , Germany

Praxis Roßbach

Mansfeld OT Großörner, , Germany

private practise Harmuth

Marktredwitz, , Germany

Private Practise Bödekker

Marl, , Germany

private practise Reck

Mittelherwigsdorf, , Germany

private practise Vollmer

Mönchengladbach, , Germany

private practise Krüger

München, , Germany

Stadt Klinikum Muenchen

München, , Germany

private practise Raub

Münster, , Germany

private practise Berger

Naunhof, , Germany

private practise Klopsch

Neubrandenburg, , Germany

Rheumazentrum SH Mitte GbR

Neumünster, , Germany

private practise Scholz

Neustadt-Glewe, , Germany

private practise Kloos

Neuwied, , Germany

Private Practise Hein

Nienburg, , Germany

Private Practise Vogel

Nuremberg, , Germany

private practise Albert

Offenburg, , Germany

private practise Voglau

Oldenburg, , Germany

private practise Gräßler

Pirna, , Germany

private practise Welcker

Planegg, , Germany

private practise Baumann

Plauen, , Germany

Private Practise Petersen

Potsdam, , Germany

Rheumahaus Potsdam GbR

Potsdam, , Germany

Knappschaftskrankenhaus Püttlingen

Püttlingen, , Germany

private practise Wassenberg

Ratingen, , Germany

private practise Schwokowski

Ratzeburg, , Germany

private practise Rumpel

Regensburg, , Germany

Private Practise Walter

Rendburg, , Germany

Private Practise Kotterik

Reutlingen, , Germany

Private Practise Hoene

Rostock, , Germany

private practise Richter

Rostock, , Germany

private practise Lankow

Rostock, , Germany

private practise Biewer

Saarbrücken, , Germany

Private Practise Mobius

Schwerin, , Germany

private practise Möbius

Schwerin, , Germany

private practise Ständer

Schwerin, , Germany

private practise Melzer

Seesen, , Germany

Company for Medical Study&Service Selters

Selters/Ww, , Germany

Private Practise Hoese

Stadthagen, , Germany

private practise Steinborn

Straubing, , Germany

private practise Engel

Stuttgart, , Germany

ZIRS - Zentrum für Interdisziplinäre Rheumatologie Stuttgart

Stuttgart, , Germany

Private Practice Fahr

Suhl, , Germany

private practise Pyra

Torgelow, , Germany

MVZ der Johanniter

Treuenbrietzen, , Germany

Praxis Dr. Haas

Tübingen, , Germany

Private Practice Jacki

Tübingen, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Berufsausübungsgemeinschaft Dr. med Petra Roll und Dr. Margarete Kratzsch

Ulm / Donau, , Germany

private practise Rinaldi

Ulm / Donau, , Germany

Praxis Dres. Winkler-Gyulay, Moeller

Unna, , Germany

private practise Otte

Wesel, , Germany

private practise Schuart

Wissen/ Luhe, , Germany

private practise Metz

Wittstock, , Germany

private practise Senger

Wunstorf, , Germany

Klinikverbund St. Antonius und St. Josef GmbH, Krankenhaus St. Josef

Wuppertal, , Germany

Private Practise Sprekeler

Zeven, , Germany

private practise Fricke-Wagner

Zwickau, , Germany

private practise Alliger

Zwiesel, , Germany

Countries

Germany

References

Feist E, Baraliakos X, Behrens F, Thaci D, Plenske A, Klaus P, Meng T. Etanercept in Axial Spondyloarthritis, Psoriatic Arthritis, and Plaque Psoriasis: Real-World Outcome Data from German Non-interventional Study ADEQUATE. Rheumatol Ther. 2024 Apr;11(2):331-348. doi: 10.1007/s40744-023-00633-2. Epub 2024 Feb 3.

Reference Type: DERIVED

PMID: 38308727 (View on PubMed)

Feist E, Baraliakos X, Behrens F, Thaci D, Klopsch T, Plenske A, Blindzellner LK, Klaus P, Meng T, Loschmann PA. Effectiveness of Etanercept in Rheumatoid Arthritis: Real-World Data from the German Non-interventional Study ADEQUATE with Focus on Treat-to-Target and Patient-Reported Outcomes. Rheumatol Ther. 2022 Apr;9(2):621-635. doi: 10.1007/s40744-021-00418-5. Epub 2022 Feb 3.

Reference Type: DERIVED

PMID: 35113363 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801385&StudyName=A%20Prospective%2C%20Multicenter%20Non-interventional%20Study%20To%20Evaluate%20The%20Efficacy%20Of%20Enbrel%20%28registered%29%20%28etanercept%29%20Over%20A%20Period%20Of%2012%20Months%20In%20The%20Routine%20Treatment%20Of%20Patients%20With%20Rheumatoid%20Arthritis%2C%20Axial%20Spondyloarthritis%2C%20Psoriatic%20Arthritis%2C%20Or%20Plaque%20Psoriasis%20With%20Particular%20Focus%20On%20The%20Clinical%20Status%20Improvements%20Still%20Observable%20After%2012%20Weeks%20Of%20Treatment

To obtain contact information for a study center near you, click here.

Other Identifiers

ADEQUATE

Identifier Type: OTHER

Identifier Source: secondary_id

B1801385

Identifier Type: -

Identifier Source: org_study_id