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)

March 29, 2019 updated by: Pfizer

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

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,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Etanercept

Study Type

Observational

Enrollment (Actual)

1534

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Aachen, Germany, 52062
    - private practise Hemmerich
  - Aachen, Germany, 52064
    - private practise Kurthen
  - Alsfeld, Germany, 36304
    - Gesundheits- und Pflegezentrum Alsfeld gGmbH
  - Altenburg, Germany, 4600
    - private practise Kupka
  - Altenholz, Germany, 24161
    - Private Practise Boehm
  - Amberg, Germany, 92224
    - Private Practise Marycz
  - Bad Bramstedt, Germany, 24576
    - Klinikum Bad Bramstedt
  - Bad Bramstedt, Germany, 24576
    - private practise Gause
  - Bad Homburg, Germany, 61348
    - private practise Messis
  - Bad Kreuznach, Germany, 55543
    - ACURA Rheumazentrum Bad Kreuznach
  - Bad Kreuznach, Germany, 55543
    - private practise Hesse
  - Bamberg, Germany, 96047
    - private practise Manger
  - Bautzen, Germany, 2625
    - private practise Balzer
  - Bautzen, Germany, 2625
    - private practise Winkler
  - Bayreuth, Germany, 95444
    - private practise Ochs
  - Bayreuth, Germany, 95444
    - private practise Schmitt-Haendle
  - Berlin, Germany, 10117
    - Charité Berlin Rheumatologie und Klinische Immunologie
  - Berlin, Germany, 10117
    - Med. Versorgungszentrum Ambulantes Gesundheitszentrum Charite Campus Mitte
  - Berlin, Germany, 10117
    - private practise Hasert
  - Berlin, Germany, 10247
    - Praxis Roßbacher
  - Berlin, Germany, 10713
    - private practise Bozorg
  - Berlin, Germany, 12161
    - private practise Brandt-Jürgens
  - Berlin, Germany, 12435
    - private practise Herzberg
  - Berlin, Germany, 12435
    - private practise Remstedt
  - Berlin, Germany, 12555
    - private practise Seifert
  - Berlin, Germany, 13055
    - private practise Zinke
  - Berlin, Germany, 13086
    - private practise Kors
  - Berlin, Germany, 13125
    - Rheumaklinik Berlin-Buch
  - Berlin, Germany, 13507
    - private practise Miehe
  - Berlin, Germany, 14163
    - private practise Schnorfeil
  - Bogen, Germany, 94327
    - private practise Koelnberger
  - Borna, Germany, 4552
    - private practise Barth
  - Braunschweig, Germany, 38100
    - private practise Eisterhues
  - Braunschweig, Germany, 38114
    - Private Practise Ramaker-Brunke
  - Bremen, Germany, 28195
    - private practise Mall
  - Bremen, Germany, 28779
    - private practise Schwichtenberg
  - Bruchhausen-Vilsen, Germany, 27305
    - Private Practise Wagener
  - Burghausen, Germany, 84489
    - private practise Feuchtenberger
  - Bückeburg, Germany, 31675
    - private practise Budde
  - Chemnitz, Germany, 09130
    - Mvz Agliomed
  - Chemnitz, Germany, 9116
    - private practise Schneider
  - Cottbus, Germany, 3046
    - private practise Geißler
  - Deggendorf, Germany, 94469
    - private practise Kirrstetter
  - Demmin, Germany, 17109
    - Kreiskrankenhaus Demmin GmbH
  - Dessau, Germany, 6842
    - private practise Heidlas
  - Dortmund, Germany, 44309
    - private practise Bebnowski
  - Dresden, Germany, 1097
    - private practise Gerlach
  - Dresden, Germany, 1097
    - private practise Lüthke
  - Dresden, Germany, 1277
    - private practise Fischer
  - Dresden, Germany, 1277
    - private practise Oppers
  - Dresden, Germany, 1277
    - private practise Roch
  - Duisburg, Germany, 47057
    - private practise Fendler
  - Duisburg, Germany, 47249
    - private practise Riesopp
  - Düsseldorf, Germany, 40211
    - private practise Strothmeyer
  - Ebensfeld, Germany, 96250
    - Bezirksklinikum Obermain
  - Eberswalde, Germany, 16225
    - private practise Berendt
  - Eberswalde, Germany, 16225
    - private practise Pech
  - Elmshorn, Germany, 25335
    - Asklepios MVZ Nord SH GmbH, c/o AK St. Georg
  - Elsterwerda, Germany, 49110
    - Elbe Elster MVZ GmbH
  - Erfurt, Germany, 99096
    - MVZ Kaestner + Kaestner GbR
  - Erfurt, Germany, 99096
    - private practise Koch
  - Essen, Germany, 45147
    - Universitaetsklinikum Essen, Klinik fuer Dermatologie
  - Falkensee, Germany, 14612
    - private practise Freitag
  - Frankenberg, Germany, 9669
    - private practise Häckel
  - Frankfurt, Germany, 15230
    - private practise Fritzsch
  - Frankfurt/Main, Germany, 60590
    - Klinikum der J.W. Goethe-Universität, Klinik für Dermatologie, Klinische Forschung
  - Fraureuth, Germany, 8427
    - private practise Höhne
  - Freiberg, Germany, 9588
    - private practise Müller
  - Fulda, Germany, 36093
    - private practise Behringer
  - Geilenkirchen, Germany, 52511
    - private practise Bussmann
  - Geislingen A.d. Steige, Germany, 73312
    - private practise Zeh
  - Germering, Germany, 82110
    - Private Practice Abahji
  - Giessen, Germany, 35392
    - Private Practise
  - Gladbeck, Germany, 45964
    - Praxis Dres. Dr.Brinkmann, Schult, Samimi-Fard
  - Haldensleben, Germany, 39340
    - private practise Kühne
  - Halle, Germany, 6128
    - private practise Liebhaber
  - Hamburg, Germany, 20095
    - MVZ Rheumatologie und Autoimmunmedizin GmbH
  - Hamburg, Germany, 21073
    - MVZ Nord GmbH
  - Hamburg, Germany, 22087
    - Katholisches Marienkrankenhaus Geriatrische Klinik
  - Hamburg, Germany, 22147
    - Private Practise Höhle
  - Hamburg, Germany, 22415
    - private practise Dahmen
  - Hamburg, Germany, 22523
    - private practise Weinhardt
  - Hamburg, Germany, 22767
    - private practise Aries
  - Hamm, Germany, 59065
    - Praxis Praxis Dr. Szabo & Kollegen
  - Hannover, Germany, 30161
    - Private Practise Stille
  - Hannover, Germany, 30167
    - private practise Stein
  - Heidelberg, Germany, 69120
    - UniversitatsKlinikum Heidelberg
  - Heidelberg, Germany, 69120
    - private practise Heilig
  - Heidelberg, Germany, 69120
    - private practise Lassak-Siedl
  - Heilbad Heiligenstadt, Germany, 37308
    - private Practise Pawlak
  - Heilbad Heiligenstadt, Germany, 37308
    - private practise Schleußner
  - Herrsching, Germany, 82211
    - private practise Thies
  - Hofheim, Germany, 65719
    - private practise Meier
  - Hohen Neuendorf, Germany, 16540
    - private practise Wernicke
  - Holzkirchen, Germany, 83607
    - Private Practice Streibl
  - Hoyerswerda, Germany, 2977
    - private practise Kapelle
  - Jena, Germany, 7747
    - Uniklinik Jena
  - Jülich, Germany, 52428
    - Private Practise Kremers
  - Kahla, Germany, 7768
    - private practise Bräunig
  - Kamenz, Germany, 1917
    - Praxis Mauer
  - Karlstadt, Germany, 97753
    - Private Practise Turin
  - Kiel, Germany, 24105
    - private practise Schwab
  - Koeln, Germany, 50937
    - Office of Parysa Alborz, MD
  - Kronach, Germany, 96317
    - private practise Straub
  - Köln, Germany, 50825
    - private practise Wilden
  - Königs Wusterhausen, Germany, 15711
    - private practise Merkel
  - Langenau, Germany, 89129
    - Kreiskrankenhaus Langenau
  - Leipzig, Germany, 4109
    - Boche-Hamann-Teich
  - Leipzig, Germany, 4129
    - private practise Schwarze
  - Leipzig, Germany, 4275
    - private practise Zeiger
  - Leipzig, Germany, 4317
    - private practise Wiemers
  - Lichtenstein, Germany, 9350
    - private practise Weiß
  - Ludwigslust, Germany, 19288
    - private practise Holst
  - Luebeck, Germany, 23564
    - Private Practise Legler
  - Magdeburg, Germany, 39104
    - private practise Kudela
  - Magdeburg, Germany, 39104
    - private practise Raschke
  - Magdeburg, Germany, 39104
    - private practise Sieburg
  - Magdeburg, Germany, 39110
    - private practise Weimann
  - Mainz, Germany, 55101
    - Hautklinik der Universitätsmedizin Mainz KöR,Clinical Research Center
  - Malchow, Germany, 17213
    - private practise Zimmermann
  - Mansfeld OT Großörner, Germany, 06343
    - Praxis Roßbach
  - Marktredwitz, Germany, 95615
    - private practise Harmuth
  - Marl, Germany, 45768
    - Private Practise Bödekker
  - Mittelherwigsdorf, Germany, 2763
    - private practise Reck
  - Monchengladbach, Germany, 41061
    - private practise Vollmer
  - Munchen, Germany, 81925
    - Stadt Klinikum Muenchen
  - München, Germany, 81541
    - private practise Krüger
  - Münster, Germany, 48143
    - private practise Raub
  - Naunhof, Germany, 4683
    - private practise Berger
  - Neubrandenburg, Germany, 17033
    - private practise Klopsch
  - Neumünster, Germany, 24534
    - Rheumazentrum SH Mitte GbR
  - Neustadt-Glewe, Germany, 19306
    - private practise Scholz
  - Neuwied, Germany, 56564
    - private practise Kloos
  - Nienburg, Germany, 31582
    - Private Practise Hein
  - Nürnberg, Germany, 90482
    - Private Practise Vogel
  - Offenburg, Germany, 77652
    - private practise Albert
  - Oldenburg, Germany, 26123
    - private practise Voglau
  - Pirna, Germany, 1796
    - private practise Gräßler
  - Planegg, Germany, 82152
    - private practise Welcker
  - Plauen, Germany, 8523
    - private practise Baumann
  - Potsdam, Germany, 14469
    - Private Practise Petersen
  - Potsdam, Germany, 14469
    - Rheumahaus Potsdam GbR
  - Püttlingen, Germany, 66346
    - Knappschaftskrankenhaus Püttlingen
  - Ratingen, Germany, 40882
    - private practise Wassenberg
  - Ratzeburg, Germany, 23909
    - private practise Schwokowski
  - Regensburg, Germany, 93051
    - private practise Rumpel
  - Reken, Germany, 48734
    - private practise Schumann
  - Rendburg, Germany, 24768
    - Private Practise Walter
  - Reutlingen, Germany, 72764
    - Private Practise Kotterik
  - Rostock, Germany, 18059
    - Private Practise Hoene
  - Rostock, Germany, 18059
    - private practise Richter
  - Rostock, Germany, 18069
    - private practise Lankow
  - Saarbrücken, Germany, 66111
    - private practise Biewer
  - Schwerin, Germany, 19053
    - private practise Möbius
  - Schwerin, Germany, 19053
    - private practise Ständer
  - Seesen, Germany, 38723
    - private practise Melzer
  - Selters/Ww, Germany, 56242
    - Company for Medical Study&Service Selters
  - Stadthagen, Germany, 31655
    - Private Practise Hoese
  - Straubing, Germany, 94315
    - private practise Steinborn
  - Stuttgart, Germany, 70178
    - private practise Engel
  - Stuttgart, Germany, 70372
    - ZIRS - Zentrum für Interdisziplinäre Rheumatologie Stuttgart
  - Suhl, Germany, 98529
    - Private Practice Fahr
  - Torgelow, Germany, 17358
    - private practise Pyra
  - Treuenbrietzen, Germany, 14929
    - MVZ der Johanniter
  - Tübingen, Germany, 72076
    - Universitatsklinikum Tubingen
  - Tübingen, Germany, 72072
    - Praxis Dr. Haas
  - Tübingen, Germany, 72072
    - Private Practice Jacki
  - Ulm / Donau, Germany, 89073
    - Berufsausübungsgemeinschaft Dr. med Petra Roll und Dr. Margarete Kratzsch
  - Ulm / Donau, Germany, 89073
    - private practise Rinaldi
  - Unna, Germany, 59423
    - Praxis Dres. Winkler-Gyulay, Moeller
  - Wesel, Germany, 46483
    - private practise Otte
  - Wissen/ Luhe, Germany, 21423
    - private practise Schuart
  - Wittstock, Germany, 16909
    - private practise Metz
  - Wunstorf, Germany, 31515
    - private practise Senger
  - Wuppertal, Germany, 42105
    - Klinikverbund St. Antonius und St. Josef GmbH, Krankenhaus St. Josef
  - Zeven, Germany, 27404
    - Private Practise Sprekeler
  - Zwickau, Germany, 8056
    - private practise Fricke-Wagner
  - Zwiesel, Germany, 94227
    - private practise Alliger
- Sachsen
  - Dresden, Sachsen, Germany, 01109
    - Rheumatologisches MVZ Dresden GmbH im Gesundheitszentrum Dresden - Klotzsche (GZDK)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ambulatory and Hospital care patients treated for Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriasis Arthritis or Plaque Psoriasis in Germany

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation Group	Drug: Etanercept Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 Time Frame: 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 Time Frame: 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 Time Frame: Week 12 up to Week 52	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 Time Frame: Week 24 up to Week 52	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 Time Frame: Week 12	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 sectionarea scoreweighing 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 sectionarea scoreweighing 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 Time Frame: 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 Time Frame: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) Time Frame: Baseline up to Weeks 12, 24, 36, 52		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 Time Frame: Baseline up to Weeks 12, 24, 36, 52		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 Time Frame: Baseline up to Weeks 12, 24, 36, 52	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.	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 Time Frame: Baseline up to Weeks 12, 24, 36, 52	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.	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 Time Frame: Weeks 12, 24, 36, 52	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. Participants who had DAS28 <= 2.6 were considered in remission.	Weeks 12, 24, 36, 52
Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.	Weeks 12, 24, 36, 52
Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.	Weeks 12, 24, 36, 52
Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).	Weeks 12, 24, 36, 52
Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.	Weeks 12, 24, 36, 52
Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).	Weeks 12, 24, 36, 52
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Time Frame: Weeks 12, 24, 36, 52	The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.	Weeks 12, 24, 36, 52
Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Time Frame: Weeks 12, 24, 36, 52	The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.	Weeks 12, 24, 36, 52
Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Time Frame: Weeks 12, 24, 36, 52	The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.	Weeks 12, 24, 36, 52
Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 Time Frame: Weeks 12, 24, 36, 52	The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.	Weeks 12, 24, 36, 52
Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Time Frame: Weeks 12, 24, 36, 52	FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).	Weeks 12, 24, 36, 52
Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Time Frame: Weeks 12, 24, 36, 52	FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).	Weeks 12, 24, 36, 52
Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 Time Frame: Weeks 12, 24, 36, 52	FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).	Weeks 12, 24, 36, 52
Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events Time Frame: Baseline up to Week 52	Percentage of participants who discontinued etanercept before completing the study, was reported.	Baseline up to Week 52
Number of Participants Who Switched to Other Therapy After Treatment Discontinuation Time Frame: Baseline up to Week 52	Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.	Baseline up to Week 52
Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 Time Frame: Weeks 12, 24, 36, 52	FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicated better daily activities.	Weeks 12, 24, 36, 52
Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.	Weeks 12, 24, 36, 52
Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.	Weeks 12, 24, 36, 52
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).	Weeks 12, 24, 36, 52
Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.	Weeks 12, 24, 36, 52
Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.	Weeks 12, 24, 36, 52
Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.	Weeks 12, 24, 36, 52
Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.	Weeks 12, 24, 36, 52
Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Time Frame: Baseline, Weeks 12, 24, 36, 52	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each sectionarea scoreweight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.	Baseline, Weeks 12, 24, 36, 52
Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) Time Frame: Baseline up to Week 24	PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & 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; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.	Baseline up to Week 24
Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) Time Frame: Weeks 12, 24, 36, 52	PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).	Weeks 12, 24, 36, 52
Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) Time Frame: Weeks 12, 24, 36, 52	PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & 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; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each sectionarea scoreweighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).	Weeks 12, 24, 36, 52
Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI < 2; small effect at 2 <=DLQI <= 5; moderate effect at 6 <=DLQI <= 10; very large effect at 11<=DLQI <= 20; extremely large effect at 21 <= DLQI <= 30.	Weeks 12, 24, 36, 52
Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus".	Weeks 12, 24, 36, 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.	Weeks 12, 24, 36, 52
C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Weeks 12, 24, 36, 52
Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.	Weeks 12, 24, 36, 52
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 Time Frame: Weeks 12, 24, 36, 52	To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.	Weeks 12, 24, 36, 52
Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) Time Frame: Baseline	Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.	Baseline
Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 Time Frame: Weeks 36, 52	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.	Weeks 36, 52
Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52 Time Frame: Weeks 36, 52	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.	Weeks 36, 52
Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of "Clear" or "Almost Clear" And DLQI Total Score of 0 or 1 at Weeks 36 and 52 Time Frame: Weeks 36, 52	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 sectionarea scoreweighing 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).	Weeks 36, 52
Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 Time Frame: Weeks 36, 52	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. Participants who had DAS28 <= 2.6 were considered in remission.	Weeks 36, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2015

Primary Completion (Actual)

December 11, 2017

Study Completion (Actual)

December 11, 2017

Study Registration Dates

First Submitted

June 28, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

B1801385
ADEQUATE (Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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mAbxience Research S.L.

Recruiting

A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis

Rheumatoid Arthritis (RA)

Moldova, Republic of, Bulgaria, Poland, Romania, Serbia, Georgia
Amgen

Completed

Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis

Arthritis, Rheumatoid; Arthritis, Psoriatic

United States, Puerto Rico
mAbxience Research S.L.

Completed

A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders (MB04-A-01-23)

Healthy Volunteers

Netherlands
Amgen

Completed

Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept

Rheumatoid Arthritis | Plaque Psoriasis

United States, Canada
Sun Yat-sen University

Completed

A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis

Spondyloarthropathy

China

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)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Etanercept

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations