Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
20 febbraio 2013 aggiornato da: Pfizer
A 3-Month, Randomised, Open-Label, Parallel-Group, Descriptive Study To Explore And Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis
The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study describes patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e.g. ease of use, convenience, confidence, presence or absence of fear, side effects related to administration) is captured using a questionnaire based on the outputs of patient interviews.
The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, self efficacy, expectations of treatment, perception of their illness) and RA characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
640
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Frederiksberg, Danimarca, 02000
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Hjorring, Danimarca, 09800
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Holbaek, Danimarca, 04300
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Silkeborg, Danimarca, DK-8600
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Helsinki, Finlandia, 00130
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Hyvinkaa, Finlandia, 05800
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Joensuu, Finlandia, 802 10
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Lohja, Finlandia, 08200
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Amiens, Francia, 80054
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Aulnay-sous-Bois, Francia, 93602
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Avignon, Francia, 84000
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Boulogne Billancourt, Francia, 92104
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Brest, Francia, 29609
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Cahors, Francia, 49000
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Corbeilles-Essonnes, Francia, 91100
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Grenoble, Francia, 38043
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Lille, Francia, 59037
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Lyon, Francia, 69091
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Marseille, Francia, 13008
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Montpellier, Francia, 34000
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Montpellier, Francia, 34059
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Niort, Francia, 79021
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Orléans, Francia, 45032
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Paris, Francia, 75013
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Paris, Francia, 75018
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Pierre-Bénite, Francia, 69495
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Reims, Francia, 51092
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Rouen, Francia, 76031
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Toulouse, Francia, 31054
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Vandoeuvre-les-Nancy, Francia, 54511
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Bad Abbach, Germania, 93077
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Bad Nauheim, Germania, 61231
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Berlin, Germania, 13125
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Berlin, Germania, 10777
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Duesseldorf, Germania, 40211
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Erlangen, Germania, 91056
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Essen, Germania, 45326
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Goettingen, Germania, 37075
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Hannover, Germania, 30159
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Hannover, Germania, 30161
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Hofheim/Taunus, Germania, 65719
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Köln, Germania, 50924
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Leipzig, Germania, 04103
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Muenchen, Germania, 80336
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Nienburg, Germania, 31582
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Oberammergau, Germania, 82487
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Osnabrueck, Germania, 49074
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Tübingen, Germania, 72076
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Villingen-Schwenningen, Germania, 78034
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Wuerzburg, Germania, 97080
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Zeven, Germania, 27404
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Bay
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Erlangen, Bay, Germania, 91054
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Hessen
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Frankfurt, Hessen, Germania, 60590
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Sachsen
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Pirna, Sachsen, Germania, 01796
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Alessandria, Italia, 15100
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Bologna, Italia, 40133
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Cagliari, Italia, 09042
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Cinisello Balsamo, Italia, 20099
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Como, Italia, 22100
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Coppito, Italia, 67010
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Fano, Italia, 61032
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Ferrara, Italia, 44100
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Foggia, Italia, 71100
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Massa, Italia, 54100
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Milano, Italia, 20124
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Napoli, Italia, 80137
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Napoli, Italia, 80144
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Padova, Italia, 35128
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Palermo, Italia, 90100
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Parma, Italia, 43100
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Reggio Calabria, Italia, 89133
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Rieti, Italia, 02100
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Roma, Italia, 00189
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Roma, Italia, 00165
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S. Dona di Piave, Italia, 30027
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Terni, Italia, 05100
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Torino, Italia, 10128
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Torrette di Ancona, Italia, 60020
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Verona, Italia, 37134
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Vimercate, Italia, 20059
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Avellino
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Ariano Irpino, Avellino, Italia, 83031
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Brescia
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S. Pietro Vernotico, Brescia, Italia, 72027
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Lecce
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San Cesario di Lecce, Lecce, Italia, 73016
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Gjettum, Norvegia, 01346
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Harstad, Norvegia, 09480
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Kristiansand, Norvegia, 04615
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Lillehammer, Norvegia, 02609
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Skien, Norvegia, 03722
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Trondheim, Norvegia, NO-7030
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Tønsberg, Norvegia, 03118
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Arnhem, Olanda, 6815 AD
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Eindhoven, Olanda, 5631 BM
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Rotterdam, Olanda, 3078 HT
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Ashford, Regno Unito, TW15 3AA
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Basingstoke, Regno Unito, RG24 9NA
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Cambridge, Regno Unito, CB2 2QQ
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Chertsey, Regno Unito, KT16 0PZ
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London, Regno Unito, SE1 9RT
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London, Regno Unito, E1 4DG
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Manchester, Regno Unito, M13 9WL
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Portsmouth, Regno Unito, PO6 3LY
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Southampton, Regno Unito, SO16 6YD
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Stoke on Trent, Regno Unito
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Truro, Regno Unito, TR1 3LJ
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Westcliff on Sea, Regno Unito, SS0 0RY
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Wigan, Regno Unito, WN6 9EP
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Danderyd, Svezia, 182 88
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Malmö, Svezia, SE-205 02
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Stockholm, Svezia, 11152
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Sundsvall, Svezia, 851 86
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Uppsala, Svezia, 75185
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Vasterås, Svezia, 721 89
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Västerås, Svezia, 72189
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion:
- Diagnosis of RA according to the ACR-Criteria.
- Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
- Willing and able to self-inject etanercept.
Exclusion:
- Prior experience of biologics and anti-TNF treatment for their RA including etanercept.
- Sepsis or risk of sepsis.
- Current or recent infections, including chronic or localized.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Enbrel 50 mg Prefilled Syringe
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
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Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
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Sperimentale: Enbrel 50 mg Autoinjector
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
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Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population
Lasso di tempo: Day 84
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Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher score indicated greater satisfaction with the delivery mechanism.
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Day 84
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Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population
Lasso di tempo: Day 84
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Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher score indicated greater satisfaction with the delivery mechanism.
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Day 84
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 28
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Percentage of participants answering "Yes" to the question "Are you satisfied with your injection device?"
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Day 28
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Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Percentage of participants answering "Yes" to the question "Are you satisfied with your injection device?"
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Day 84
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Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction with the delivery mechanism.
Results are reported by age categories: <=46 years, >46-55 years, >55-65 years, >65 years.
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Day 84
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Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction with the delivery mechanism.
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Day 84
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Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction with the delivery mechanism.
Participants were categorized into those having only reading/writing capacity, those at the high-school/baccalaureate level, and those at the university level.
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Day 84
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Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction with the delivery mechanism.
The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, odd-numbered questions related to anxiety.
Responses scored on a 4-point scale; each question was graded in a different way.
Anxiety subscale scores ranged from 0 to 21. Lower HAD Anxiety subscale scores indicated better health.
Categories are anxiety subscale scores.
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Day 84
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Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction with the delivery mechanism.
The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, even-numbered questions related to depression.
Responses scored on a 4-point scale; each question was graded in a different way.
Depression subscale scores ranged from 0 to 21. Lower HAD Depression subscale scores indicated better health.
Categories are depression subscale scores.
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Day 84
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Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction for the delivery mechanism.
The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100.
Higher scores indicated more confidence in managing participants' condition and lifestyle.
Results reported by PAM score: <=49.9, >49.9-56.4,
>56.4-66, >66.
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Day 84
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Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Participants were grouped into 2 categories: those who did and did not have prior self-injection experience.
Higher scores indicated greater satisfaction in the delivery mechanism.
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Day 84
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Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction for the delivery mechanism.
Results are reported by duration of RA: <=3 years, >3-6 years, >6-13 years, >13 years.
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Day 84
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Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction for the delivery mechanism.
DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale.
Score ranged from 0 to 9.4.
Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1,
or high when score >5.1, remission when score <2.6.
Results are reported by categories of DAS28 score: <=4.7, >4.7-5.4,
>5.4-6.2, >6.2.
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Day 84
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Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction for the delivery mechanism.
Participants' global assessment of disease activity was measured on a visual analog scale (VAS) ranging from 0 (inactive) to 100 millimeter (mm) (extremely active).
Results are reported by VAS scores observed for the participant's global assessment of RA activity: <=50 mm, >50-67 mm, >67-79 mm, >79 mm.
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Day 84
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Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction with the delivery mechanism.
Physicians' global assessment of disease activity was measured on a VAS ranging from 0 (inactive) to 100 mm (extremely active).
Results are reported by VAS scores observed for physician's global assessment of RA activity: <=47 mm, >47-61 mm, >61-72 mm, >72 mm.
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Day 84
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Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction with the delivery mechanism.
The 20-item HAQ-DI assessed the extent of participants' functional ability.
Calculation yielded a single disability score from 0=normal or no difficulty to 3=unable to do.
Lower HAQ-DI scores indicated better health.
Results are reported by categories of HAQ-DI scores observed: <=0.9, >0.9-1.4,
>1.4-1.9, >1.9.
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Day 84
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Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction for the delivery mechanism.
Participants were categorized into those who received only 1 DMARD, only 2 DMARDs, only 3 DMARDs, and at least 3 DMARDs.
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Day 84
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Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept
Lasso di tempo: Day 84
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Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied.
Participants were grouped into 2 categories: those who did and did not have prior injection experience.
Higher scores indicated greater satisfaction with the delivery mechanism.
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Day 84
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Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score
Lasso di tempo: Day 84
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The SF-STAI consisted of 6 questions, each scored from 1 to 4. Total score ranged from 6=less anxiety to 24=more anxiety.
Higher score indicated that the participant was more anxious.
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Day 84
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Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?
Lasso di tempo: Day 84
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Score indicated satisfaction in response to the question "Thinking about your own life and personal circumstances, how satisfied are you with your life as a whole?"
Score ranged from 0=completely dissatisfied to 10=completely satisfied.
Higher scores indicated greater satisfaction.
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Day 84
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Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?
Lasso di tempo: Day 84
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Score indicated satisfaction in response to the question "How satisfied are you with your health?"
Score ranged from 0=completely dissatisfied to 10=completely satisfied.
Higher scores indicated greater satisfaction.
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Day 84
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Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?
Lasso di tempo: Day 84
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Score indicated satisfaction in response to the question "How satisfied are you with all the treatments you are currently receiving for your rheumatoid arthritis?"
Score ranged from 0=completely dissatisfied to 10=completely satisfied.
Higher scores indicated greater satisfaction.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q1: Overall, How Easy Was It to Perform an Injection with this Device?
Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q2: How Easy Was It to Learn to Use the Device?
Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q3: How Easy Is It to Dispose Of the Device?
Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q4: How Easy Is It to Know When the Injection Is Completed?
Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q5: How Easy Is It to Hold the Device Whilst Injecting?
Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q6: Did You Feel any Hand Discomfort Whilst Using the Device?
Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q7: How Long Does It Take to Perform the Injection, Including any Preparation and Disposal?
Participants specified their responses on a 5-point Likert scale: 0=<5 minutes to 4=>30 minutes.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q8: How Much Do You Think Injecting Etanercept Will Interfere with Your Ability to Enjoy Social or Leisure Activities?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q9: Do You Think Injecting Etanercept Will Interfere with Your Usual Daily Activities?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q10: How Much Do You Think Injecting Etanercept Will Interfere with Travelling on Holiday/ Business/Visiting?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q11: Overall, How Confident Are You in Your Management of Your Weekly Injections?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q12: How Confident Are You That You Inject the Right Amount of Medicine Every Time?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q13: How Confident Are You That You Can Inject Yourself Properly with the Device?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q14: Are You Confident That You Have Good Control over the Injection Process?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q15: How Confident Are You That You Injected Yourself Successfully?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q16: Overall, How Nervous Do You Feel about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q17: Overall, How Nervous Do You Feel about Inserting the Needle into Your Skin? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q18: Do You Dislike Injecting Yourself with this Device?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q19: Overall, Are You Emotionally Distressed or Anxious about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q20: How Much Do You Like the Look of the Device?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q21: How Much Do You Like the Feel of the Device?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q22: How Much Does the Device Look Like Something You Would Feel Comfortable to Use? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: Side Effects from Using the Device - Q23: Do You Experience Pain During or Immediately After the Injection?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q24: To What Extent Would You Consider Alternative Devices If You Were to Continue on Etanercept?
Participants specified their responses on a 5-point Likert scale: 0=very little to 4=very much.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q25: Would You Recommend this Device to Someone Else Who Needed to Self Inject?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=yes definitely.
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Day 84
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Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84
Lasso di tempo: Day 84
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Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q26: If Your Doctor Advised You to, How Likely Would You to Be Continue Injecting Regularly With this Device?
Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very likely.
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Day 84
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Age Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The mean age was determined for each cluster of participants.
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Day 84
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Percentage of Male Participants Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The percentage of participants who were male was determined for each cluster of participants.
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Day 84
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Percentage of Female Participants Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Percentage of participants who were female was determined for each cluster of participants.
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Day 84
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Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Percentage of participants with only reading/writing capacity was determined for each cluster of participants.
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Day 84
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Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Percentage of participants at high school/baccalaureate level was determined for each cluster of participants.
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Day 84
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Percentage of Participants at University Level Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Percentage of participants at the university level was determined for each cluster of participants.
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Day 84
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HAD Anxiety Subscale Score Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The mean HAD Anxiety Subscale Score was determined for each cluster of participants.
Score ranged from 0 to 21. Lower scores indicated better health.
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Day 84
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HAD Depression Subscale Score Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The mean HAD Depression Subscale Score was determined for each cluster of participants.
Score ranged from 0 to 21. Lower scores indicated better health.
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Day 84
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PAM Score Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The mean PAM Score was determined for each cluster of participants.
Calibrated PAM scale score ranged from 0 to 100.Higher scores indicated more confidence in managing participants' condition and lifestyle.
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Day 84
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Percentage of Participants With Prior Injection Experience Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The percentage of participants with prior injection experience was determined for each cluster of participants.
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Day 84
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Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using a multiple correspondence analysis and an ascending hierarchical classification.
The percentage of participants with prior self-injection experience was determined for each cluster of participants.
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Day 84
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RA Duration Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The mean RA Duration was determined for each cluster of participants.
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Day 84
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DAS28 Score Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The mean DAS28 Score was determined for each cluster of participants.
Score ranged from 0 to 9.4.
Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1,
or high when score >5.1, remission when score <2.6.
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Day 84
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Participant's Global Assessment of RA Activity Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Participants' mean Global Assessment of RA Activity was determined for each cluster of participants.
VAS scores ranged from 0 (inactive) to 100 mm (extremely active).
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Day 84
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Physician's Global Assessment of RA Activity Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Mean Physician's Global Assessment of RA Activity was determined for each cluster of participants.
VAS scores ranged from 0 (inactive) to 100 mm (extremely active).
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Day 84
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HAQ-DI Score Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
The mean HAQ-DI Score, assessing the extent of functional ability, was determined for each cluster of participants.
Disability score ranged from 0=normal or no difficulty to 3=unable to do.
Lower HAQ-DI scores indicated better health.
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Day 84
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Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Percentage of participants receiving only 1 DMARD was determined for each cluster of participants.
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Day 84
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Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Percentage of participants receiving only 2 DMARDs was determined for each cluster of participants.
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Day 84
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Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Percentage of participants receiving only 3 DMARDs was determined for each cluster of participants.
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Day 84
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Participant Satisfaction at Endpoint Associated With Participant Perception
Lasso di tempo: Day 84
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Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire.
Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification.
Mean participant satisfaction was determined for each cluster of participants.
Satisfaction was scored on a 10-point scale: 0=totally dissatisfied to 10=totally satisfied.
Higher scores indicated greater satisfaction.
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Day 84
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2007
Completamento primario (Effettivo)
1 aprile 2009
Completamento dello studio (Effettivo)
1 settembre 2009
Date di iscrizione allo studio
Primo inviato
11 aprile 2007
Primo inviato che soddisfa i criteri di controllo qualità
11 aprile 2007
Primo Inserito (Stima)
12 aprile 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
28 marzo 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 febbraio 2013
Ultimo verificato
1 febbraio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie articolari
- Malattie muscoloscheletriche
- Malattie reumatiche
- Malattie del tessuto connettivo
- Artrite
- Artrite, reumatoide
- Effetti fisiologici delle droghe
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti gastrointestinali
- Etanercept
Altri numeri di identificazione dello studio
- 0881K1-6000
- B1801017 (Altro identificatore: Pfizer)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .