Phase 3
Completed N=640
Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Source: ClinicalTrials.gov NCT00459706 ↗Enrolled (actual)
640
Serious AEs
4.2%
Results posted
Mar 2013
Primary outcomePrimary: Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population — 8.3; 7.2 units on a scale — p=<0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population |
8.3; 7.2 | <0.001 sig |
| PRIMARY Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population |
8.4; 7.2 | <0.001 sig |
| SECONDARY Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept |
92.7; 88.6 | 0.058 |
| SECONDARY Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept |
93.3; 87.7 | 0.019 sig |
| SECONDARY Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept |
8.18; 6.58; 8.81; 7.01; 8.31; 7.56 | 0.160 |
| SECONDARY Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept |
8.45; 8.13; 8.21; 6.89 | 0.001 sig |
| SECONDARY Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept |
8.11; 7.53; 8.32; 6.90; 8.44; 7.09 | 0.676 |
| SECONDARY Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept |
8.56; 7.67; 8.13; 7.32; 7.87; 6.93 | 0.020 sig |
| SECONDARY Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept |
8.75; 7.70; 7.97; 7.35; 8.28; 7.17 | 0.008 sig |
| SECONDARY Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept |
7.91; 7.06; 8.48; 7.42; 8.02; 6.97 | 0.030 sig |
| SECONDARY Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept |
8.10; 6.57; 8.34; 7.49 | 0.006 sig |
| SECONDARY Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept |
7.99; 7.32; 8.39; 6.68; 8.52; 7.24 | 0.278 |
| SECONDARY Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept |
8.24; 7.01; 8.11; 7.36; 8.45; 7.58 | 0.749 |
| SECONDARY Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept |
8.45; 7.55; 8.41; 7.31; 8.07; 7.11 | 0.105 |
| SECONDARY Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept |
8.23; 7.40; 8.36; 6.92; 8.03; 7.14 | 0.819 |
| SECONDARY Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept |
8.61; 7.67; 8.27; 7.40; 8.33; 7.03 | 0.012 sig |
| SECONDARY Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept |
8.29; 7.23; 8.18; 7.19; 8.94; 6.85 | 0.541 |
| SECONDARY Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept |
8.29; 7.05; 8.24; 7.37 | 0.465 |
| SECONDARY Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score |
10.0; 10.5 | 0.154 |
| SECONDARY Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole? |
7.3; 7.1 | 0.212 |
| SECONDARY Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health? |
6.1; 6.1 | 0.965 |
| SECONDARY Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA? |
7.4; 7.3 | 0.519 |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84 |
69.5; 54.2; 17.1; 26.1; 7.0; 12.5 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84 |
75.3; 62.9; 15.9; 30.6; 5.4; 5.1 | 0.007 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84 |
85.4; 74.9; 10.4; 19.2; 2.4; 4.8 | 0.002 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84 |
81.1; 63.4; 13.1; 26.1; 2.7; 7.8 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84 |
63.7; 47.3; 23.3; 26.9; 7.9; 16.0 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84 |
69.0; 54.3; 18.5; 19.9; 7.7; 15.1 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84 |
64.7; 57.6; 22.0; 30.8; 6.8; 6.8 | 0.184 |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84 |
71.1; 64.3; 14.3; 17.7; 7.0; 11.3 | 0.106 |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84 |
78.8; 73.2; 12.3; 15.7; 5.6; 5.7 | 0.112 |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84 |
60.5; 48.0; 20.6; 23.0; 9.3; 17.7 | 0.002 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84 |
2.3; 2.0; 1.6; 5.4; 6.2; 8.4 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84 |
1.3; 1.3; 2.3; 5.0; 5.6; 7.3 | 0.022 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84 |
3.0; 1.7; 3.0; 6.0; 5.9; 8.4 | 0.009 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84 |
2.3; 1.7; 2.6; 4.0; 5.6; 7.7 | 0.007 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84 |
2.6; 1.0; 2.0; 3.7; 4.9; 8.7 | 0.014 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84 |
66.7; 49.0; 19.3; 25.3; 8.8; 15.0 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84 |
64.3; 45.8; 21.3; 27.8; 6.9; 12.4 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84 |
70.8; 46.0; 17.4; 22.0; 6.6; 14.3 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84 |
70.6; 57.2; 18.0; 22.7; 7.2; 8.7 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84 |
1.6; 10.4; 3.6; 10.1; 19.4; 35.9 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84 |
3.0; 9.5; 3.0; 10.8; 20.1; 35.1 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84 |
4.0; 12.1; 3.6; 8.8; 18.2; 31.6 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84 |
36.2; 39.6; 28.0; 29.9; 20.4; 17.8 | 0.196 |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84 |
48.8; 28.4; 8.8; 21.1; 20.8; 22.8 | 0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84 |
3.3; 4.4; 2.3; 5.4; 7.6; 24.7 | <0.001 sig |
| SECONDARY Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84 |
3.0; 3.7; 3.0; 7.7; 9.3; 17.8 | <0.001 sig |
| SECONDARY Age Associated With Participant Perception |
54.3; 56.0; 55.1; 54.1; 54.0; 52.7 | 0.896 |
| SECONDARY Percentage of Male Participants Associated With Participant Perception |
30.9; 30.1; 23.5; 29.6; 14.9; 14.1 | 0.069 |
| SECONDARY Percentage of Female Participants Associated With Participant Perception |
69.1; 69.9; 76.5; 70.4; 85.1; 85.9 | 0.069 |
| SECONDARY Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception |
35.0; 44.7; 45.1; 42.9; 36.2; 33.7 | 0.652 |
| SECONDARY Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception |
48.8; 43.2; 37.3; 41.4; 48.9; 47.8 | 0.652 |
| SECONDARY Percentage of Participants at University Level Associated With Participant Perception |
16.3; 12.1; 17.6; 15.7; 14.9; 18.5 | 0.652 |
| SECONDARY HAD Anxiety Subscale Score Associated With Participant Perception |
6.8; 6.4; 7.9; 7.4; 8.3; 8.7 | 0.023 sig |
| SECONDARY HAD Depression Subscale Score Associated With Participant Perception |
5.8; 5.0; 6.6; 5.2; 7.3; 6.7 | 0.038 sig |
| SECONDARY PAM Score Associated With Participant Perception |
61.6; 60.1; 56.6; 56.5; 57.4; 55.3 | 0.018 sig |
| SECONDARY Percentage of Participants With Prior Injection Experience Associated With Participant Perception |
52.9; 54.9; 47.1; 54.9; 70.2; 59.8 | 0.049 sig |
| SECONDARY Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception |
31.9; 31.6; 15.7; 36.6; 38.3; 31.5 | 0.033 sig |
| SECONDARY RA Duration Associated With Participant Perception |
8.6; 9.7; 9.4; 8.6; 8.9; 10.3 | 0.838 |
| SECONDARY DAS28 Score Associated With Participant Perception |
5.3; 5.5; 5.4; 5.0; 5.5; 5.5 | 0.466 |
| SECONDARY Participant's Global Assessment of RA Activity Associated With Participant Perception |
63.5; 62.5; 64.7; 57.5; 65.7; 68.2 | 0.784 |
| SECONDARY Physician's Global Assessment of RA Activity Associated With Participant Perception |
58.8; 60.8; 58.3; 57.4; 60.3; 60.1 | 0.843 |
| SECONDARY HAQ-DI Score Associated With Participant Perception |
1.4; 1.3; 1.5; 1.3; 1.5; 1.6 | 0.150 |
| SECONDARY Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception |
55.4; 55.3; 52.0; 53.5; 54.3; 48.4 | 0.934 |
| SECONDARY Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception |
38.1; 37.1; 42.0; 36.6; 41.3; 44.0 | 0.934 |
| SECONDARY Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception |
4.5; 7.6; 6.0; 9.9; 4.3; 7.7 | 0.934 |
| SECONDARY Participant Satisfaction at Endpoint Associated With Participant Perception |
9.0; 8.0; 8.1; 8.2; 5.5; 5.3 | <0.001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00459706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.