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

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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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Plaque Psoriasis Drug: Etanercept via Autoinjector A Drug: Etanercept via Autoinjector B Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 5, 2013
Actual Primary Completion Date : March 4, 2014
Actual Study Completion Date : March 4, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

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 Name: Enbrel® SureClick®




Primary Outcome Measures :
  1. 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?"


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875991


Locations
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United States, Alabama
Research Site
Huntsville, Alabama, United States, 35801
Research Site
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Research Site
Glendale, Arizona, United States, 85304
Research Site
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Research Site
Hot Springs, Arkansas, United States, 71913
United States, California
Research Site
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
United States, Colorado
Research Site
Denver, Colorado, United States, 80230
United States, Florida
Research Site
Dunedin, Florida, United States, 34698
Research Site
Tampa, Florida, United States, 33614
United States, Kansas
Research Site
Overland Park, Kansas, United States, 66215
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40217
United States, Maryland
Research Site
Frederick, Maryland, United States, 21702
United States, Michigan
Research Site
Lansing, Michigan, United States, 48910
United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68516
United States, New York
Research Site
Orchard Park, New York, United States, 14127
United States, North Dakota
Research Site
Bismarck, North Dakota, United States, 58502
United States, Ohio
Research Site
Dayton, Ohio, United States, 45417
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
Research Site
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29414
United States, Tennessee
Research Site
Hixson, Tennessee, United States, 37343
United States, Texas
Research Site
Austin, Texas, United States, 78731
Research Site
Dallas, Texas, United States, 75231
United States, West Virginia
Research Site
Clarksburg, West Virginia, United States, 26301
Canada, British Columbia
Research Site
Victoria, British Columbia, Canada, V8V 3P9
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1C 5B8
Canada, Ontario
Research Site
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
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01875991    
Other Study ID Numbers: 20090176
First Posted: June 12, 2013    Key Record Dates
Results First Posted: May 20, 2015
Last Update Posted: September 4, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors