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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00459706
First received: April 11, 2007
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Rheumatoid Arthritis
Device: Enbrel 50 mg Prefilled Syringe
Device: Enbrel 50 mg Autoinjector
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Percentage of participants answering "Yes" to the question "Are you satisfied with your injection device?"

  • Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    Percentage of participants answering "Yes" to the question "Are you satisfied with your injection device?"

  • Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole? [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health? [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA? [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Age Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Male Participants Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Female Participants Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants at University Level Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • HAD Anxiety Subscale Score Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • HAD Depression Subscale Score Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • PAM Score Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Prior Injection Experience Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • RA Duration Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • DAS28 Score Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant's Global Assessment of RA Activity Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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).

  • Physician's Global Assessment of RA Activity Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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).

  • HAQ-DI Score Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction at Endpoint Associated With Participant Perception [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
    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.


Enrollment: 640
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enbrel 50 mg Prefilled Syringe
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe
Device: 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
Device: Enbrel 50 mg Autoinjector
Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459706

  Show 113 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00459706     History of Changes
Obsolete Identifiers: NCT00595452
Other Study ID Numbers: 0881K1-6000, B1801017
Study First Received: April 11, 2007
Results First Received: September 7, 2011
Last Updated: February 20, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014