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Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

20. Februar 2013 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

640

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Deutschland
      • Bad Abbach, Deutschland, 93077
      • Bad Nauheim, Deutschland, 61231
      • Berlin, Deutschland, 13125
      • Berlin, Deutschland, 10777
      • Duesseldorf, Deutschland, 40211
      • Erlangen, Deutschland, 91056
      • Essen, Deutschland, 45326
      • Goettingen, Deutschland, 37075
      • Hannover, Deutschland, 30159
      • Hannover, Deutschland, 30161
      • Hofheim/Taunus, Deutschland, 65719
      • Köln, Deutschland, 50924
      • Leipzig, Deutschland, 04103
      • Muenchen, Deutschland, 80336
      • Nienburg, Deutschland, 31582
      • Oberammergau, Deutschland, 82487
      • Osnabrueck, Deutschland, 49074
      • Tübingen, Deutschland, 72076
      • Villingen-Schwenningen, Deutschland, 78034
      • Wuerzburg, Deutschland, 97080
      • Zeven, Deutschland, 27404
    • Bay
      • Erlangen, Bay, Deutschland, 91054
    • Hessen
      • Frankfurt, Hessen, Deutschland, 60590
    • Sachsen
      • Pirna, Sachsen, Deutschland, 01796
  • Dänemark
      • Frederiksberg, Dänemark, 02000
      • Hjorring, Dänemark, 09800
      • Holbaek, Dänemark, 04300
      • Silkeborg, Dänemark, DK-8600
  • Finnland
      • Helsinki, Finnland, 00130
      • Hyvinkaa, Finnland, 05800
      • Joensuu, Finnland, 802 10
      • Lohja, Finnland, 08200
  • Frankreich
      • Amiens, Frankreich, 80054
      • Aulnay-sous-Bois, Frankreich, 93602
      • Avignon, Frankreich, 84000
      • Boulogne Billancourt, Frankreich, 92104
      • Brest, Frankreich, 29609
      • Cahors, Frankreich, 49000
      • Corbeilles-Essonnes, Frankreich, 91100
      • Grenoble, Frankreich, 38043
      • Lille, Frankreich, 59037
      • Lyon, Frankreich, 69091
      • Marseille, Frankreich, 13008
      • Montpellier, Frankreich, 34000
      • Montpellier, Frankreich, 34059
      • Niort, Frankreich, 79021
      • Orléans, Frankreich, 45032
      • Paris, Frankreich, 75013
      • Paris, Frankreich, 75018
      • Pierre-Bénite, Frankreich, 69495
      • Reims, Frankreich, 51092
      • Rouen, Frankreich, 76031
      • Toulouse, Frankreich, 31054
      • Vandoeuvre-les-Nancy, Frankreich, 54511
  • Italien
      • Alessandria, Italien, 15100
      • Bologna, Italien, 40133
      • Cagliari, Italien, 09042
      • Cinisello Balsamo, Italien, 20099
      • Como, Italien, 22100
      • Coppito, Italien, 67010
      • Fano, Italien, 61032
      • Ferrara, Italien, 44100
      • Foggia, Italien, 71100
      • Massa, Italien, 54100
      • Milano, Italien, 20124
      • Napoli, Italien, 80137
      • Napoli, Italien, 80144
      • Padova, Italien, 35128
      • Palermo, Italien, 90100
      • Parma, Italien, 43100
      • Reggio Calabria, Italien, 89133
      • Rieti, Italien, 02100
      • Roma, Italien, 00189
      • Roma, Italien, 00165
      • S. Dona di Piave, Italien, 30027
      • Terni, Italien, 05100
      • Torino, Italien, 10128
      • Torrette di Ancona, Italien, 60020
      • Verona, Italien, 37134
      • Vimercate, Italien, 20059
    • Avellino
      • Ariano Irpino, Avellino, Italien, 83031
    • Brescia
      • S. Pietro Vernotico, Brescia, Italien, 72027
    • Lecce
      • San Cesario di Lecce, Lecce, Italien, 73016
  • Niederlande
      • Arnhem, Niederlande, 6815 AD
      • Eindhoven, Niederlande, 5631 BM
      • Rotterdam, Niederlande, 3078 HT
  • Norwegen
      • Gjettum, Norwegen, 01346
      • Harstad, Norwegen, 09480
      • Kristiansand, Norwegen, 04615
      • Lillehammer, Norwegen, 02609
      • Skien, Norwegen, 03722
      • Trondheim, Norwegen, NO-7030
      • Tønsberg, Norwegen, 03118
  • Schweden
      • Danderyd, Schweden, 182 88
      • Malmö, Schweden, SE-205 02
      • Stockholm, Schweden, 11152
      • Sundsvall, Schweden, 851 86
      • Uppsala, Schweden, 75185
      • Vasterås, Schweden, 721 89
      • Västerås, Schweden, 72189
  • Vereinigtes Königreich
      • Ashford, Vereinigtes Königreich, TW15 3AA
      • Basingstoke, Vereinigtes Königreich, RG24 9NA
      • Cambridge, Vereinigtes Königreich, CB2 2QQ
      • Chertsey, Vereinigtes Königreich, KT16 0PZ
      • London, Vereinigtes Königreich, SE1 9RT
      • London, Vereinigtes Königreich, E1 4DG
      • Manchester, Vereinigtes Königreich, M13 9WL
      • Portsmouth, Vereinigtes Königreich, PO6 3LY
      • Southampton, Vereinigtes Königreich, SO16 6YD
      • Stoke on Trent, Vereinigtes Königreich
      • Truro, Vereinigtes Königreich, TR1 3LJ
      • Westcliff on Sea, Vereinigtes Königreich, SS0 0RY
      • Wigan, Vereinigtes Königreich, WN6 9EP

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Enbrel 50 mg Prefilled Syringe
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
Gerät: Enbrel 50 mg Prefilled Syringe
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
Experimental: Enbrel 50 mg Autoinjector
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
Gerät: Enbrel 50 mg Autoinjector
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population
Zeitfenster: Day 84
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.
Day 84

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 28
Percentage of participants answering "Yes" to the question "Are you satisfied with your injection device?"
Day 28
Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
Percentage of participants answering "Yes" to the question "Are you satisfied with your injection device?"
Day 84
Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept
Zeitfenster: Day 84
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.
Day 84
Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score
Zeitfenster: Day 84
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.
Day 84
Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?
Zeitfenster: Day 84
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.
Day 84
Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?
Zeitfenster: Day 84
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.
Day 84
Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84
Zeitfenster: Day 84
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.
Day 84
Age Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Male Participants Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Female Participants Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants at University Level Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
HAD Anxiety Subscale Score Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
HAD Depression Subscale Score Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
PAM Score Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants With Prior Injection Experience Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
RA Duration Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
DAS28 Score Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Participant's Global Assessment of RA Activity Associated With Participant Perception
Zeitfenster: Day 84
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).
Day 84
Physician's Global Assessment of RA Activity Associated With Participant Perception
Zeitfenster: Day 84
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).
Day 84
HAQ-DI Score Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84
Participant Satisfaction at Endpoint Associated With Participant Perception
Zeitfenster: Day 84
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.
Day 84

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2007

Primärer Abschluss (Tatsächlich)

1. April 2009

Studienabschluss (Tatsächlich)

1. September 2009

Studienanmeldedaten

Zuerst eingereicht

11. April 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. April 2007

Zuerst gepostet (Schätzen)

12. April 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

28. März 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Februar 2013

Zuletzt verifiziert

1. Februar 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 0881K1-6000
  • B1801017 (Andere Kennung: Pfizer)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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