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AzTrials

Rheumatoid ArthritisPhase 3NCT00459706

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

A Phase 3 study testing Enbrel 50 mg Prefilled Syringe and Enbrel 50 mg Autoinjector in people with Rheumatoid Arthritis, run by Pfizer at 113 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Enbrel 50 mg Prefilled Syringe and Enbrel 50 mg Autoinjector
Could I receive a placebo?
No, everyone receives an active treatment
How many people
640 participants
Where
113 sitesin 9 countries
Study dates
Sep 2007to Sep 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

113 sites in 9 countries.

113 sites in 9 countries

Italy29 sites
  • Study site

    Alessandria, 15100

  • Study site

    Ariano Irpino, Avellino, 83031

  • Study site

    Bologna, 40133

  • Study site

    Cagliari, 09042

  • Study site

    Cinisello Balsamo, 20099

  • Study site

    Como, 22100

  • Study site

    Coppito, 67010

  • Study site

    Fano, 61032

  • Study site

    Ferrara, 44100

  • Study site

    Foggia, 71100

  • Study site

    Massa, 54100

  • Study site

    Milan, 20124

  • Study site

    Naples, 80137

  • Study site

    Naples, 80144

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90100

  • Study site

    Parma, 43100

  • Study site

    Reggio Calabria, 89133

  • Study site

    Rieti, 02100

  • Study site

    Roma, 00165

  • Study site

    Roma, 00189

  • Study site

    S. Dona Di Piave, 30027

  • Study site

    S. Pietro Vernotico, Brescia, 72027

  • Study site

    San Cesario di Lecce, Lecce, 73016

  • Study site

    Terni, 05100

  • Study site

    Torino, 10128

  • Study site

    Torrette Di Ancona, 60020

  • Study site

    Verona, 37134

  • Study site

    Vimercate, 20059

Other trials in Italy

Germany24 sites
  • Study site

    Bad Abbach, 93077

  • Study site

    Bad Nauheim, 61231

  • Study site

    Berlin, 10777

  • Study site

    Berlin, 13125

  • Study site

    Cologne, 50924

  • Study site

    Düsseldorf, 40211

  • Study site

    Erlangen, Bay, 91054

  • Study site

    Erlangen, 91056

  • Study site

    Essen, 45326

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Göttingen, 37075

  • Study site

    Hanover, 30159

  • Study site

    Hanover, 30161

  • Study site

    Hofheim/Taunus, 65719

  • Study site

    Leipzig, 04103

  • Study site

    München, 80336

  • Study site

    Nienburg, 31582

  • Study site

    Oberammergau, 82487

  • Study site

    Osnabrück, 49074

  • Study site

    Pirna, Saxony, 01796

  • Study site

    Tübingen, 72076

  • Study site

    Villingen-Schwenningen, 78034

  • Study site

    Würzburg, 97080

  • Study site

    Zeven, 27404

Other trials in Germany

France22 sites
  • Study site

    Amiens, 80054

  • Study site

    Aulnay-sous-Bois, 93602

  • Study site

    Avignon, 84000

  • Study site

    Boulogne-Billancourt, 92104

  • Study site

    Brest, 29609

  • Study site

    Cahors, 49000

  • Study site

    Corbeilles-Essonnes, 91100

  • Study site

    Grenoble, 38043

  • Study site

    Lille, 59037

  • Study site

    Lyon, 69091

  • Study site

    Marseille, 13008

  • Study site

    Montpellier, 34000

  • Study site

    Montpellier, 34059

  • Study site

    Niort, 79021

  • Study site

    Orléans, 45032

  • Study site

    Paris, 75013

  • Study site

    Paris, 75018

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Reims, 51092

  • Study site

    Rouen, 76031

  • Study site

    Toulouse, 31054

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United Kingdom13 sites
  • Study site

    Ashford, TW15 3AA

  • Study site

    Basingstoke, RG24 9NA

  • Study site

    Cambridge, CB2 2QQ

  • Study site

    Chertsey, KT16 0PZ

  • Study site

    London, E1 4DG

  • Study site

    London, SE1 9RT

  • Study site

    Manchester, M13 9WL

  • Study site

    Portsmouth, PO6 3LY

  • Study site

    Southampton, SO16 6YD

  • Study site

    Stoke-on-Trent

  • Study site

    Truro, TR1 3LJ

  • Study site

    Westcliff-on-Sea, SS0 0RY

  • Study site

    Wigan, WN6 9EP

Other trials in United Kingdom

Norway7 sites
  • Study site

    Gjettum, 01346

  • Study site

    Harstad, 09480

  • Study site

    Kristiansand, 04615

  • Study site

    Lillehammer, 02609

  • Study site

    Skien, 03722

  • Study site

    Tønsberg, 03118

  • Study site

    Trondheim, NO-7030

Other trials in Norway

Sweden7 sites
  • Study site

    Danderyd, 182 88

  • Study site

    Malmö, SE-205 02

  • Study site

    Stockholm, 11152

  • Study site

    Sundsvall, 851 86

  • Study site

    Uppsala, 75185

  • Study site

    Vasterås, 721 89

  • Study site

    Västerås, 72189

Other trials in Sweden

Denmark4 sites
  • Study site

    Frederiksberg, 02000

  • Study site

    Hjørring, 09800

  • Study site

    Holbæk, 04300

  • Study site

    Silkeborg, DK-8600

Other trials in Denmark

Finland4 sites
  • Study site

    Helsinki, 00130

  • Study site

    Hyvinkää, 05800

  • Study site

    Joensuu, 802 10

  • Study site

    Lohja, 08200

Other trials in Finland

Netherlands3 sites
  • Study site

    Arnhem, 6815 AD

  • Study site

    Eindhoven, 5631 BM

  • Study site

    Rotterdam, 3078 HT

Other trials in Netherlands

About this study

Official title: 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).

Read the detailed description

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).

Being tested
Enbrel 50 mg Prefilled Syringe, Enbrel 50 mg Autoinjector
Keywords
Rheumatoid Arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enbrel 50 mg Prefilled SyringeDevice

    Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe

  • Enbrel 50 mg AutoinjectorDevice

    Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector

Study groups in NCT00459706
Study groupRoleWhat they receive
Enbrel 50 mg Prefilled SyringeExperimentalEnbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
Receives: Device: Enbrel 50 mg Prefilled Syringe
Enbrel 50 mg AutoinjectorExperimentalEnbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector
Receives: Device: Enbrel 50 mg Autoinjector

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population

    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.

    Measured: Day 84

  2. Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population

    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.

    Measured: Day 84

Secondary outcomes (66)
  1. Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept

    Percentage of participants answering "Yes" to the question "Are you satisfied with your injection device?"

    Measured: Day 28

  2. Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept

    Percentage of participants answering "Yes" to the question "Are you satisfied with your injection device?"

    Measured: Day 84

  3. Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  4. Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  5. Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  6. Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  7. Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  8. Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  9. Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  10. Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  11. Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  12. Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  13. Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  14. Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  15. Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  16. Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept

    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.

    Measured: Day 84

  17. Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score

    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.

    Measured: Day 84

  18. Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?

    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.

    Measured: Day 84

  19. Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?

    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.

    Measured: Day 84

  20. Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?

    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.

    Measured: Day 84

  21. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, 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.

    Measured: Day 84

  22. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, 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.

    Measured: Day 84

  23. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, 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.

    Measured: Day 84

  24. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, 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.

    Measured: Day 84

  25. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, 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.

    Measured: Day 84

  26. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, 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.

    Measured: Day 84

  27. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, 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.

    Measured: Day 84

  28. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, 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.

    Measured: Day 84

  29. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, 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.

    Measured: Day 84

  30. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, 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.

    Measured: Day 84

  31. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, 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.

    Measured: Day 84

  32. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, 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.

    Measured: Day 84

  33. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, 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.

    Measured: Day 84

  34. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, 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.

    Measured: Day 84

  35. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, 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.

    Measured: Day 84

  36. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, 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.

    Measured: Day 84

  37. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, 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.

    Measured: Day 84

  38. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, 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.

    Measured: Day 84

  39. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, 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.

    Measured: Day 84

  40. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, 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.

    Measured: Day 84

  41. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, 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.

    Measured: Day 84

  42. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, 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.

    Measured: Day 84

  43. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, 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.

    Measured: Day 84

  44. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, 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.

    Measured: Day 84

  45. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, 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.

    Measured: Day 84

  46. Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, 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.

    Measured: Day 84

  47. Age Associated With Participant Perception

    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.

    Measured: Day 84

  48. Percentage of Male Participants Associated With Participant Perception

    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.

    Measured: Day 84

  49. Percentage of Female Participants Associated With Participant Perception

    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.

    Measured: Day 84

  50. Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception

    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.

    Measured: Day 84

  51. Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception

    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.

    Measured: Day 84

  52. Percentage of Participants at University Level Associated With Participant Perception

    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.

    Measured: Day 84

  53. HAD Anxiety Subscale Score Associated With Participant Perception

    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.

    Measured: Day 84

  54. HAD Depression Subscale Score Associated With Participant Perception

    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.

    Measured: Day 84

  55. PAM Score Associated With Participant Perception

    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.

    Measured: Day 84

  56. Percentage of Participants With Prior Injection Experience Associated With Participant Perception

    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.

    Measured: Day 84

  57. Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception

    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.

    Measured: Day 84

  58. RA Duration Associated With Participant Perception

    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.

    Measured: Day 84

  59. DAS28 Score Associated With Participant Perception

    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.

    Measured: Day 84

  60. Participant's Global Assessment of RA Activity Associated With Participant Perception

    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).

    Measured: Day 84

  61. Physician's Global Assessment of RA Activity Associated With Participant Perception

    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).

    Measured: Day 84

  62. HAQ-DI Score Associated With Participant Perception

    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.

    Measured: Day 84

  63. Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception

    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.

    Measured: Day 84

  64. Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception

    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.

    Measured: Day 84

  65. Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception

    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.

    Measured: Day 84

  66. Participant Satisfaction at Endpoint Associated With Participant Perception

    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.

    Measured: Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionApr 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
640 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00459706
Sponsor's protocol ID
0881K1-6000
Other IDs
B1801017
Status last verified
Feb 2013
First submitted
11 Apr 2007
Last updated
28 Mar 2013

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enbrel 50 mg Prefilled Syringe and Enbrel 50 mg Autoinjector in people with Rheumatoid Arthritis, run by Pfizer at 113 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in Italy, Germany, France, United Kingdom, Norway and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population (time frame: Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.

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