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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01875991
Recruitment Status : Completed
First Posted : June 12, 2013
Results First Posted : May 20, 2015
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE June 10, 2013
First Posted Date  ICMJE June 12, 2013
Results First Submitted Date  ICMJE March 3, 2015
Results First Posted Date  ICMJE May 20, 2015
Last Update Posted Date September 4, 2018
Actual Study Start Date  ICMJE June 5, 2013
Actual Primary Completion Date March 4, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B [ Time Frame: Week 8 ]
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?"
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
Preference for autoinjector A versus autoinjector B assessed by the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at week 8. [ Time Frame: At week 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
  • Change From Baseline in Needle Apprehension at Week 4 [ Time Frame: Baseline and 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).
  • Ease of Use [ Time Frame: At the end of each treatment period; Week 4 and Week 8 ]
    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.
  • Certainty of Completing the Injection With the Autoinjector [ Time Frame: At the end of each treatment period; Week 4 and Week 8 ]
    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.
  • Convenience [ Time Frame: At the end of each treatment period; Week 4 and Week 8 ]
    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.
  • Discomfort [ Time Frame: At the end of each treatment period; Week 4 and Week 8 ]
    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.
  • Satisfaction [ Time Frame: At the end of each treatment period; Week 4 and Week 8 ]
    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.
  • Pain Associated With Use of the Autoinjector [ Time Frame: At the end of each treatment period; Week 4 and Week 8 ]
    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.
  • Strength of Preference for Autoinjector A and Autoinjector B [ Time Frame: Week 8 ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
  • Using the Subject's Perception of Self-injecting Questionnaire the following secondary endpoint will be evaluated at baseline and at week 4 prior to training with the autoinjector [ Time Frame: At baseline and Week 4 ]
    Change from baseline in needle apprehension at week 4
  • Using the Subject's Experience with the Autoinjector Questionnaire, the following secondary endpoints will be evaluated after the completion of each 4-week treatment period [ Time Frame: At week 4 and week 8 ]
    Ease of use
  • Certainty of Completing the Injection With the Autoinjector [ Time Frame: At week 4 and week 8 ]
    Certainty of completing the injection with the autoinjector
  • Convenience [ Time Frame: At week 4 and week 8 ]
    Convenience
  • Discomfort [ Time Frame: At week 4 and week 8 ]
    Discomfort
  • Satisfaction [ Time Frame: at week 4 and week 8 ]
    Satisfaction
  • Pain Associated With Use of the Autoinjector [ Time Frame: At week 4 and week 8 ]
    Pain associated with use of the autoinjector
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 10, 2013)
Adverse Events and Adverse Device Effects [ Time Frame: Ongoing from randomization through week 8 ]
 
Descriptive Information
Brief Title  ICMJE Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rheumatoid Arthritis
  • Plaque Psoriasis
Intervention  ICMJE
  • 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.
  • 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 Name: Enbrel® SureClick®
Study Arms  ICMJE
  • Experimental: Autoinjector A
    Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
    Intervention: Drug: Etanercept via Autoinjector A
  • Experimental: Autoinjector B
    Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
    Intervention: Drug: Etanercept via Autoinjector B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2014)
217
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2013)
210
Actual Study Completion Date  ICMJE March 4, 2014
Actual Primary Completion Date March 4, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01875991
Other Study ID Numbers  ICMJE 20090176
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP