Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept

An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept

The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Plaque Psoriasis
• Intervention / Treatment: Drug: Etanercept via Autoinjector A; Drug: Etanercept via Autoinjector B

Detailed Description

Candidates for treatment are those who in the determination of the investigator's standard of care and the caring physician's intent are to initiate treatment with etanercept. Participants must be naïve to etanercept and naïve to other autoinjector pens or prefilled syringes and be able to self-inject. The study will consist of a 30 day screening period, and 2 treatment periods of 4 weeks duration each (one treatment period using Autoinjector A and the other using Autoinjector B). At the end of the study, participants may continue treatment with commercially available etanercept at the physician's discretion.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 3P9
      • Research Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
      • Research Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Research Site
    • Burlington, Ontario, Canada, L7R 1E2
      • Research Site
    • Courtice, Ontario, Canada, L1E 3C3
      • Research Site
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Research Site
    • Mississauga, Ontario, Canada, L5M 2V8
      • Research Site
    • Oakville, Ontario, Canada, L6J 7W5
      • Research Site
    • Peterborough, Ontario, Canada, K9J 1Z2
      • Research Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Research Site
    • Tuscaloosa, Alabama, United States, 35406
      • Research Site
  • Arizona
    • Glendale, Arizona, United States, 85304
      • Research Site
    • Scottsdale, Arizona, United States, 85258
      • Research Site
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Research Site
  • California
    • San Diego, California, United States, 92108
      • Research Site
    • San Ramon, California, United States, 94583
      • Research Site
    • Santa Maria, California, United States, 93454-6945
      • Research Site
    • Tustin, California, United States, 92780
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80230
      • Research Site
  • Florida
    • Dunedin, Florida, United States, 34698
      • Research Site
    • Tampa, Florida, United States, 33614
      • Research Site
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Research Site
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Research Site
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Research Site
  • New York
    • Orchard Park, New York, United States, 14127
      • Research Site
  • North Dakota
    • Bismarck, North Dakota, United States, 58502
      • Research Site
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Research Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Research Site
    • Wyomissing, Pennsylvania, United States, 19610
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Research Site
  • Tennessee
    • Hixson, Tennessee, United States, 37343
      • Research Site
  • Texas
    • Austin, Texas, United States, 78731
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderate to severe Plaque Psoriasis (PsO) and a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept. - Naive to etanercept. - Naive to other autoinjector pens or prefilled syringes for Tumor Necrosis Factor (TNF)-inhibitor therapy or other subcutaneous biologics for RA. - Willing to self-inject per investigator judgement at screening and capable of self-injection using the autoinjector A or B as documented at baseline by the investigator. - Able to read and write in English. -

Exclusion Criteria: Latex allergy. - Subject has an active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept. - Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.

• Other criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autoinjector A; Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.	Drug: Etanercept via Autoinjector A; Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.
Experimental: Autoinjector B; Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.	Drug: Etanercept via Autoinjector B; Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.; Other Names: Enbrel® SureClick®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B	Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question "Which autoinjector do you prefer overall?"	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Needle Apprehension at Week 4	Participants' needle apprehension was assessed using the Subject's Perception of Self-Injecting Questionnaire. Participants answered the question "Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector" using a scale from 1 (extremely nervous) to 5 (not at all nervous).	Baseline and Week 4
Ease of Use	Ease of use was assessed based on responses to questions 1 to 6 of the Subject's Experience with the Autoinjector Questionnaire: 1. How easy was it to learn how to use the autoinjector? 2. How easy was it for you to press the button to start the injection? 3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection? 5. How easy was it for you to inject yourself using the autoinjector? 6. How easy was it to follow the progress of the injection? Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy). The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.	At the end of each treatment period; Week 4 and Week 8
Certainty of Completing the Injection With the Autoinjector	Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject's Experience with the Autoinjector Questionnaire: "How certain were you that you knew when the injection was finished?" Participants answered on a scale from 1 (Not at all) to 5 (Extremely). The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported.	At the end of each treatment period; Week 4 and Week 8
Convenience	Convenience was assessed based on responses to Question 8 of the Subject's Experience with the Autoinjector Questionnaire: "How convenient was the autoinjector to use?" Participants answered on a scale from 1 (Not at all) to 5 (Very much). The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported.	At the end of each treatment period; Week 4 and Week 8
Discomfort	Discomfort was assessed based on responses to Question 9 of the Subject's Experience with the Autoinjector Questionnaire: "How much discomfort did you experience when giving yourself the medicine using the autoinjector?" Participants answered on a scale from 1 (None) to 5 (Very much). The percentage of participants who scored a 1 (None) or 2 (A little) is reported.	At the end of each treatment period; Week 4 and Week 8
Satisfaction	Satisfaction was assessed based on responses to questions 11 and 12 of the Subject's Experience with the Autoinjector Questionnaire. Question 11: "How dependable (durable, sturdy, reliable) did you feel the autoinjector device was?" answered on a scale from 1 (Not at all) to 5 (Very much). Question 12: "Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept?" answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend). The percentage of participants who scored either a 4 or 5 on each question is reported.	At the end of each treatment period; Week 4 and Week 8
Pain Associated With Use of the Autoinjector	Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject's Experience with the Autoinjector Questionnaire: "Using this scale, select the circle that best describes how much it hurt when giving yourself an injection." Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst). The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported.	At the end of each treatment period; Week 4 and Week 8
Strength of Preference for Autoinjector A and Autoinjector B	Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8. After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).	Week 8

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2013
• Primary Completion (Actual): March 4, 2014
• Study Completion (Actual): March 4, 2014

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 12, 2013

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Arthritis; Arthritis, Rheumatoid; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 20090176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No