Phase 3
N=421
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00482170 ↗Enrolled (actual)
421
Serious AEs
2.6%
Results posted
Mar 2012
Primary outcome: Primary: Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population — 8.9; 7.6 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Enbrel (etanercept) (Device); Etanercept (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population |
8.9; 7.6 | <0.001 sig |
| PRIMARY Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population |
9.0; 7.5 | <0.001 sig |
| SECONDARY Percentage of Participants Satisfied With Injection Device |
99.5; 92.5; 98.9; 90.0; 98.4; 88.8 | 0.008 sig |
| SECONDARY Influence of Age on Participant Satisfaction With Injection Device |
8.94; 7.18; 8.91; 7.41; 9.06; 7.93 | 0.045 sig |
| SECONDARY Influence of Gender on Participant Satisfaction With Injection Device |
9.07; 7.60; 8.70; 7.68 | 0.707 |
| SECONDARY Influence of Socio-educational Status on Participant Satisfaction With Injection Device |
9.22; 7.96; 8.80; 7.55; 8.89; 7.24 | 0.195 |
| SECONDARY Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device |
8.98; 7.83; 9.17; 7.49; 8.89; 7.42 | 0.493 |
| SECONDARY Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device |
8.73; 7.05; 9.41; 7.94; 8.28; 7.94 | 0.123 |
| SECONDARY Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device |
8.89; 7.53; 8.96; 7.66 | 0.359 |
| SECONDARY Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device |
9.09; 7.90; 8.74; 7.17; 9.12; 7.72 | 0.693 |
| SECONDARY Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device |
8.87; 7.51; 8.96; 7.79; 9.62; 7.83 | 0.170 |
| SECONDARY Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device |
8.41; 7.45; 9.17; 7.81; 9.11; 7.67 | 0.211 |
| SECONDARY Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device |
8.54; 7.06; 9.15; 7.79; 8.70; 7.72 | 0.045 sig |
| SECONDARY Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device |
8.79; 7.96; 9.02; 7.51; 8.71; 7.70 | 0.913 |
| SECONDARY Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device |
8.82; 7.82; 8.94; 7.71; 8.81; 7.37 | 0.968 |
| SECONDARY Influence of Co-morbidities on Participant Satisfaction With Injection Device |
8.94; 7.40; 8.95; 7.76; 8.96; 8.06 | 0.531 |
| SECONDARY Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device |
8.95; 7.61; NA; 9.00 | 0.759 |
| SECONDARY Influence of Prior Injection Experience on Participant Satisfaction With Injection Device |
9.05; 7.70; 8.88; 7.56 | 0.713 |
| SECONDARY Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device |
134; 92; 50; 72; 15; 33 | <0.001 sig |
| SECONDARY Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device |
154; 132; 39; 57; 7; 13 | 0.004 sig |
| SECONDARY Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device |
158; 141; 25; 47; 12; 9 | 0.025 sig |
| SECONDARY Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete |
140; 129; 44; 62; 13; 10 | 0.210 |
| SECONDARY Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting |
134; 100; 48; 72; 15; 24 | <0.001 sig |
| SECONDARY Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting |
158; 131; 26; 44; 6; 20 | <0.001 sig |
| SECONDARY Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) |
132; 129; 43; 56; 12; 14 | 0.681 |
| SECONDARY Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity |
116; 134; 34; 37; 30; 20 | 0.072 |
| SECONDARY Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity |
134; 137; 45; 45; 14; 16 | 0.837 |
| SECONDARY Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling |
105; 98; 48; 55; 34; 32 | 0.356 |
| SECONDARY Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections |
6; 11; 13; 20; 30; 31 | 0.065 |
| SECONDARY Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time |
5; 2; 4; 7; 19; 15 | 0.098 |
| SECONDARY Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device |
4; 2; 3; 7; 12; 27 | 0.494 |
| SECONDARY Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process |
4; 2; 2; 10; 11; 21 | 0.628 |
| SECONDARY Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection |
3; 1; 2; 8; 16; 22 | 0.914 |
| SECONDARY Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections |
92; 80; 59; 54; 29; 39 | 0.090 |
| SECONDARY Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin |
102; 82; 44; 49; 32; 38 | 0.022 sig |
| SECONDARY Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device |
129; 103; 43; 40; 22; 29 | <0.001 sig |
| SECONDARY Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection |
124; 105; 45; 57; 28; 26 | 0.057 |
| SECONDARY Device Characteristics Based on Response to Question Concerning Look of Device |
4; 18; 10; 21; 62; 90 | <0.001 sig |
| SECONDARY Device Characteristics Based on Response to Question Concerning Feel of Device |
1; 9; 9; 24; 69; 92 | <0.001 sig |
| SECONDARY Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks |
7; 32; 11; 26; 68; 76 | <0.001 sig |
| SECONDARY Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection |
98; 109; 65; 54; 24; 31 | 0.470 |
| SECONDARY Short Form State-Trait Anxiety Inventory (SF STAI) Global Score |
11.0; 11.2; 9.9; 10.0; 10.1; 10.1 | 0.515 |
| SECONDARY Influence of Age on Participant Perception |
47.9; 49.1; 42.8; 43.9; 42.7; 42.5 | 0.030 sig |
| SECONDARY Influence of Gender on Participant Perception |
77; 67; 42; 25; 37; 45 | 0.984 |
| SECONDARY Influence of Socio-educational Status on Participant Perception |
41; 32; 56; 43; 22; 17 | 0.158 |
| SECONDARY Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception |
7.0; 6.0; 5.0; 4.0; 7.0; 7.0 | 0.029 sig |
| SECONDARY Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception |
58.0; 60.5; 53.0; 57.5; 60.0; 52.4 | 0.039 sig |
| SECONDARY Influence of Prior Injection Experience on Participant Perception |
47; 43; 72; 49; 20; 28 | 0.752 |
| SECONDARY Influence of Prior Self-injection Experience on Participant Perception |
23; 33; 96; 59; 13; 16 | 0.697 |
| SECONDARY Influence of Duration of Psoriasis on Participant Perception |
23.3; 22.9; 17.8; 20.6; 16.1; 17.1 | 0.004 sig |
| SECONDARY Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception |
3.0; 3.0; 3.0; 3.0; 3.0; 3.0 | 0.652 |
| SECONDARY Influence of Psoriasis Area Severity Index (PASI) on Participant Perception |
17.2; 17.9; 18.6; 17.5; 17.1; 15.9 | 0.560 |
| SECONDARY Influence of Participant's Assessment of General Health on Participant Perception |
64.9; 63.8; 59.3; 70.7; 48.8; 60.5 | 0.023 sig |
| SECONDARY Influence of Participant's Global Assessment of Psoriasis on Participant Perception |
73.5; 73.4; 69.9; 73.3; 72.6; 70.8 | 0.494 |
| SECONDARY Influence of Dermatology Life Quality Index (DLQI) on Participant Perception |
13.4; 13.1; 12.4; 12.8; 14.6; 13.1 | 0.444 |
| SECONDARY Influence of Co-morbidities on Participant Perception |
49; 31; 70; 61; 59; 38 | 0.787 |
| SECONDARY Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception |
119; 92; 0; 0; 56; 64 | 0.535 |
Summary
Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.
Eligibility Criteria
Inclusion Criteria
- Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
- Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
- Aged 18 years or more
- Willing and able to self-inject etanercept.
- Able to store test drug at 2-8oC.
- Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.
Exclusion Criteria
- Prior experience of biologics and anti-TNF treatment for their Psoriasis including etanercept.
- Sepsis or risk of sepsis.
- Current or recent infections, including chronic or localized.
- Latex sensitivity.
- Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.
Data sourced from ClinicalTrials.gov (NCT00482170). 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.