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.
ADEQUATE
A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL 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 WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT
2 other identifiers
observational
1,534
1 country
180
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,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Typical duration for all trials
180 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2015
CompletedFirst Submitted
Initial submission to the registry
June 28, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2017
CompletedResults Posted
Study results publicly available
June 24, 2019
CompletedJune 24, 2019
March 1, 2019
2.7 years
June 28, 2015
November 12, 2018
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (10)
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12
Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Week 12
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Week 24
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Week 12 up to Week 52
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks
DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Week 24 up to Week 52
Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Week 12
Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Week 12
Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12
DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1.
Week 12
Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24
PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
Week 24
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS.
Week 24
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24
DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1.
Week 24
Secondary Outcomes (33)
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS)
Baseline up to Weeks 12, 24, 36, 52
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set
Baseline up to Weeks 12, 24, 36, 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set
Baseline up to Weeks 12, 24, 36, 52
Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set
Baseline up to Weeks 12, 24, 36, 52
Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52
Weeks 12, 24, 36, 52
- +28 more secondary outcomes
Other Outcomes (9)
Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52
Weeks 12, 24, 36, 52
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52
Weeks 12, 24, 36, 52
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52
Weeks 12, 24, 36, 52
- +6 more other outcomes
Study Arms (1)
Observation Group
Interventions
Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.
Eligibility Criteria
Ambulatory and Hospital care patients treated for Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriasis Arthritis or Plaque Psoriasis in Germany
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (180)
Rheumatologisches MVZ Dresden GmbH im Gesundheitszentrum Dresden - Klotzsche (GZDK)
Dresden, Saxony, 01109, Germany
private practise Hemmerich
Aachen, 52062, Germany
private practise Kurthen
Aachen, 52064, Germany
Gesundheits- und Pflegezentrum Alsfeld gGmbH
Alsfeld, 36304, Germany
private practise Kupka
Altenburg, 4600, Germany
Private Practise Boehm
Altenholz, 24161, Germany
Private Practise Marycz
Amberg, 92224, Germany
Klinikum Bad Bramstedt
Bad Bramstedt, 24576, Germany
private practise Gause
Bad Bramstedt, 24576, Germany
private practise Messis
Bad Homburg, 61348, Germany
ACURA Rheumazentrum Bad Kreuznach
Bad Kreuznach, 55543, Germany
private practise Hesse
Bad Kreuznach, 55543, Germany
private practise Manger
Bamberg, 96047, Germany
private practise Balzer
Bautzen, 2625, Germany
private practise Winkler
Bautzen, 2625, Germany
private practise Ochs
Bayreuth, 95444, Germany
private practise Schmitt-Haendle
Bayreuth, 95444, Germany
Charité Berlin Rheumatologie und Klinische Immunologie
Berlin, 10117, Germany
Med. Versorgungszentrum Ambulantes Gesundheitszentrum Charite Campus Mitte
Berlin, 10117, Germany
private practise Hasert
Berlin, 10117, Germany
Praxis Roßbacher
Berlin, 10247, Germany
private practise Bozorg
Berlin, 10713, Germany
private practise Brandt-Jürgens
Berlin, 12161, Germany
private practise Herzberg
Berlin, 12435, Germany
private practise Remstedt
Berlin, 12435, Germany
private practise Seifert
Berlin, 12555, Germany
private practise Zinke
Berlin, 13055, Germany
private practise Kors
Berlin, 13086, Germany
Rheumaklinik Berlin-Buch
Berlin, 13125, Germany
private practise Miehe
Berlin, 13507, Germany
private practise Schnorfeil
Berlin, 14163, Germany
private practise Koelnberger
Bogen, 94327, Germany
private practise Barth
Borna, 4552, Germany
private practise Eisterhues
Braunschweig, 38100, Germany
Private Practise Ramaker-Brunke
Braunschweig, 38114, Germany
private practise Mall
Bremen, 28195, Germany
private practise Schwichtenberg
Bremen, 28779, Germany
Private Practise Wagener
Bruchhausen-Vilsen, 27305, Germany
private practise Feuchtenberger
Burghausen, 84489, Germany
private practise Budde
Bückeburg, 31675, Germany
Mvz Agliomed
Chemnitz, 09130, Germany
private practise Schneider
Chemnitz, 9116, Germany
private practise Wilden
Cologne, 50825, Germany
Office of Parysa Alborz, MD
Cologne, 50937, Germany
private practise Geißler
Cottbus, 3046, Germany
private practise Kirrstetter
Deggendorf, 94469, Germany
Kreiskrankenhaus Demmin GmbH
Demmin, 17109, Germany
private practise Heidlas
Dessau, 6842, Germany
private practise Bebnowski
Dortmund, 44309, Germany
private practise Gerlach
Dresden, 1097, Germany
private practise Lüthke
Dresden, 1097, Germany
private practise Fischer
Dresden, 1277, Germany
private practise Oppers
Dresden, 1277, Germany
private practise Roch
Dresden, 1277, Germany
private practise Fendler
Duisburg, 47057, Germany
private practise Riesopp
Duisburg, 47249, Germany
private practise Strothmeyer
Düsseldorf, 40211, Germany
Bezirksklinikum Obermain
Ebensfeld, 96250, Germany
private practise Berendt
Eberswalde, 16225, Germany
private practise Pech
Eberswalde, 16225, Germany
Asklepios MVZ Nord SH GmbH, c/o AK St. Georg
Elmshorn, 25335, Germany
Elbe Elster MVZ GmbH
Elsterwerda, 49110, Germany
MVZ Kaestner + Kaestner GbR
Erfurt, 99096, Germany
private practise Koch
Erfurt, 99096, Germany
Universitaetsklinikum Essen, Klinik fuer Dermatologie
Essen, 45147, Germany
private practise Freitag
Falkensee, 14612, Germany
private practise Häckel
Frankenberg, 9669, Germany
private practise Fritzsch
Frankfurt, 15230, Germany
Klinikum der J.W. Goethe-Universität, Klinik für Dermatologie, Klinische Forschung
Frankfurt am Main, 60590, Germany
private practise Höhne
Fraureuth, 8427, Germany
private practise Müller
Freiberg, 9588, Germany
private practise Behringer
Fulda, 36093, Germany
private practise Bussmann
Geilenkirchen, 52511, Germany
private practise Zeh
Geislingen A.d. Steige, 73312, Germany
Private Practice Abahji
Germering, 82110, Germany
Private Practise
Giessen, 35392, Germany
Praxis Dres. Dr.Brinkmann, Schult, Samimi-Fard
Gladbeck, 45964, Germany
private practise Schumann
Groß Reken, 48734, Germany
private practise Kühne
Haldensleben I, 39340, Germany
private practise Liebhaber
Halle, 6128, Germany
MVZ Rheumatologie und Autoimmunmedizin GmbH
Hamburg, 20095, Germany
MVZ Nord GmbH
Hamburg, 21073, Germany
Katholisches Marienkrankenhaus Geriatrische Klinik
Hamburg, 22087, Germany
Private Practise Höhle
Hamburg, 22147, Germany
private practise Dahmen
Hamburg, 22415, Germany
private practise Weinhardt
Hamburg, 22523, Germany
private practise Aries
Hamburg, 22767, Germany
Praxis Praxis Dr. Szabo & Kollegen
Hamm, 59065, Germany
Private Practise Stille
Hanover, 30161, Germany
private practise Stein
Hanover, 30167, Germany
private practise Heilig
Heidelberg, 69120, Germany
private practise Lassak-Siedl
Heidelberg, 69120, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
private Practise Pawlak
Heilbad Heiligenstadt, 37308, Germany
private practise Schleußner
Heilbad Heiligenstadt, 37308, Germany
private practise Thies
Herrsching am Ammersee, 82211, Germany
private practise Meier
Hofheim, 65719, Germany
private practise Wernicke
Hohen Neuendorf, 16540, Germany
Private Practice Streibl
Holzkirchen, 83607, Germany
private practise Kapelle
Hoyerswerda, 2977, Germany
Uniklinik Jena
Jena, 7747, Germany
Private Practise Kremers
Jülich, 52428, Germany
private practise Bräunig
Kahla, 7768, Germany
Praxis Mauer
Kamenz, 1917, Germany
Private Practise Turin
Karlstadt am Main, 97753, Germany
private practise Schwab
Kiel, 24105, Germany
private practise Merkel
Königs Wusterhausen, 15711, Germany
private practise Straub
Kronach, 96317, Germany
Kreiskrankenhaus Langenau
Langenau, 89129, Germany
Boche-Hamann-Teich
Leipzig, 4109, Germany
private practise Schwarze
Leipzig, 4129, Germany
private practise Zeiger
Leipzig, 4275, Germany
private practise Wiemers
Leipzig, 4317, Germany
private practise Weiß
Lichtenstein, 9350, Germany
private practise Holst
Ludwigslust, 19288, Germany
Private Practise Legler
Lübeck, 23564, Germany
private practise Kudela
Magdeburg, 39104, Germany
private practise Raschke
Magdeburg, 39104, Germany
private practise Sieburg
Magdeburg, 39104, Germany
private practise Weimann
Magdeburg, 39110, Germany
Hautklinik der Universitätsmedizin Mainz KöR,Clinical Research Center
Mainz, 55101, Germany
private practise Zimmermann
Malchow, 17213, Germany
Praxis Roßbach
Mansfeld OT Großörner, 06343, Germany
private practise Harmuth
Marktredwitz, 95615, Germany
Private Practise Bödekker
Marl, 45768, Germany
private practise Reck
Mittelherwigsdorf, 2763, Germany
private practise Vollmer
Mönchengladbach, 41061, Germany
private practise Krüger
München, 81541, Germany
Stadt Klinikum Muenchen
München, 81925, Germany
private practise Raub
Münster, 48143, Germany
private practise Berger
Naunhof, 4683, Germany
private practise Klopsch
Neubrandenburg, 17033, Germany
Rheumazentrum SH Mitte GbR
Neumünster, 24534, Germany
private practise Scholz
Neustadt-Glewe, 19306, Germany
private practise Kloos
Neuwied, 56564, Germany
Private Practise Hein
Nienburg, 31582, Germany
Private Practise Vogel
Nuremberg, 90482, Germany
private practise Albert
Offenburg, 77652, Germany
private practise Voglau
Oldenburg, 26123, Germany
private practise Gräßler
Pirna, 1796, Germany
private practise Welcker
Planegg, 82152, Germany
private practise Baumann
Plauen, 8523, Germany
Private Practise Petersen
Potsdam, 14469, Germany
Rheumahaus Potsdam GbR
Potsdam, 14469, Germany
Knappschaftskrankenhaus Püttlingen
Püttlingen, 66346, Germany
private practise Wassenberg
Ratingen, 40882, Germany
private practise Schwokowski
Ratzeburg, 23909, Germany
private practise Rumpel
Regensburg, 93051, Germany
Private Practise Walter
Rendburg, 24768, Germany
Private Practise Kotterik
Reutlingen, 72764, Germany
Private Practise Hoene
Rostock, 18059, Germany
private practise Richter
Rostock, 18059, Germany
private practise Lankow
Rostock, 18069, Germany
private practise Biewer
Saarbrücken, 66111, Germany
Private Practise Mobius
Schwerin, 19053, Germany
private practise Möbius
Schwerin, 19053, Germany
private practise Ständer
Schwerin, 19053, Germany
private practise Melzer
Seesen, 38723, Germany
Company for Medical Study&Service Selters
Selters/Ww, 56242, Germany
Private Practise Hoese
Stadthagen, 31655, Germany
private practise Steinborn
Straubing, 94315, Germany
private practise Engel
Stuttgart, 70178, Germany
ZIRS - Zentrum für Interdisziplinäre Rheumatologie Stuttgart
Stuttgart, 70372, Germany
Private Practice Fahr
Suhl, 98529, Germany
private practise Pyra
Torgelow, 17358, Germany
MVZ der Johanniter
Treuenbrietzen, 14929, Germany
Praxis Dr. Haas
Tübingen, 72072, Germany
Private Practice Jacki
Tübingen, 72072, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Berufsausübungsgemeinschaft Dr. med Petra Roll und Dr. Margarete Kratzsch
Ulm / Donau, 89073, Germany
private practise Rinaldi
Ulm / Donau, 89073, Germany
Praxis Dres. Winkler-Gyulay, Moeller
Unna, 59423, Germany
private practise Otte
Wesel, 46483, Germany
private practise Schuart
Wissen/ Luhe, 21423, Germany
private practise Metz
Wittstock, 16909, Germany
private practise Senger
Wunstorf, 31515, Germany
Klinikverbund St. Antonius und St. Josef GmbH, Krankenhaus St. Josef
Wuppertal, 42105, Germany
Private Practise Sprekeler
Zeven, 27404, Germany
private practise Fricke-Wagner
Zwickau, 8056, Germany
private practise Alliger
Zwiesel, 94227, Germany
Related Publications (2)
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.
PMID: 38308727DERIVEDFeist 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.
PMID: 35113363DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2015
First Posted
July 1, 2015
Study Start
March 24, 2015
Primary Completion
December 11, 2017
Study Completion
December 11, 2017
Last Updated
June 24, 2019
Results First Posted
June 24, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.