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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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
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
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
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
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
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
Denmark4 sites
Study site
Frederiksberg, 02000
Study site
Hjørring, 09800
Study site
Holbæk, 04300
Study site
Silkeborg, DK-8600
Finland4 sites
Study site
Helsinki, 00130
Study site
Hyvinkää, 05800
Study site
Joensuu, 802 10
Study site
Lohja, 08200
Netherlands3 sites
Study site
Arnhem, 6815 AD
Study site
Eindhoven, 5631 BM
Study site
Rotterdam, 3078 HT
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).
- Conditions
- Rheumatoid Arthritis
- 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 group | Role | What they receive |
|---|---|---|
| Enbrel 50 mg Prefilled Syringe | Experimental | Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe Receives: Device: Enbrel 50 mg Prefilled Syringe |
| Enbrel 50 mg Autoinjector | Experimental | Enbrel 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.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted12 Apr 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
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
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00459706
- Acronym / sponsor ID
- 0881K1-6000
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 12 Apr 2007 (estimated)
- Results
- Posted 28 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enbrel 50 mg Prefilled Syringe | Experimental | Device: Enbrel 50 mg Prefilled SyringeEnbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe |
| Enbrel 50 mg Autoinjector | Experimental | Device: Enbrel 50 mg AutoinjectorEnbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enbrel 50 mg Prefilled SyringeEnbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe | Device | Enbrel 50 mg Prefilled Syringe |
| Enbrel 50 mg AutoinjectorEnbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector | Device | Enbrel 50 mg Autoinjector |
Primary outcome
Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population
Time frame: Day 84
Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.
Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population
Time frame: Day 84
Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.
66 secondary outcomes
Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept
Time frame: Day 28
Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept
Time frame: Day 84
Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score
Time frame: Day 84
Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?
Time frame: Day 84
Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?
Time frame: Day 84
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
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84
Time frame: Day 84
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84
Time frame: Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Rheumatoid Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
113 sites in 9 countries: see every site and its status.
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.