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Rheumatoid ArthritisPhase 4NCT01875991

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

A Phase 4 study testing Etanercept via Autoinjector A and Etanercept via Autoinjector B in people with Rheumatoid Arthritis and Plaque Psoriasis, run by Amgen at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis, Plaque Psoriasis
What is being tested?
Etanercept via Autoinjector A and Etanercept via Autoinjector B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
37 sitesin 2 countries
Study dates
5 Jun 2013to 4 Mar 2014
Phase
Phase 4
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

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.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States28 sites

  • Research Site

    Austin, Texas, 78731

  • Research Site

    Bismarck, North Dakota, 58502

  • Research Site

    Charleston, South Carolina, 29414

  • Research Site

    Clarksburg, West Virginia, 26301

  • Research Site

    Dallas, Texas, 75231

  • Research Site

    Dayton, Ohio, 45417

  • Research Site

    Denver, Colorado, 80230

  • Research Site

    Duncansville, Pennsylvania, 16635

  • Research Site

    Dunedin, Florida, 34698

  • Research Site

    Frederick, Maryland, 21702

  • Research Site

    Glendale, Arizona, 85304

  • Research Site

    Hixson, Tennessee, 37343

  • Research Site

    Hot Springs, Arkansas, 71913

  • Research Site

    Huntsville, Alabama, 35801

  • Research Site

    Lansing, Michigan, 48910

  • Research Site

    Lincoln, Nebraska, 68516

  • Research Site

    Louisville, Kentucky, 40217

  • Research Site

    Oklahoma City, Oklahoma, 73103

  • Research Site

    Orchard Park, New York, 14127

  • Research Site

    Overland Park, Kansas, 66215

  • Research Site

    San Diego, California, 92108

  • Research Site

    San Ramon, California, 94583

  • Research Site

    Santa Maria, California, 93454-6945

  • Research Site

    Scottsdale, Arizona, 85258

  • Research Site

    Tampa, Florida, 33614

  • Research Site

    Tuscaloosa, Alabama, 35406

  • Research Site

    Tustin, California, 92780

  • Research Site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada9 sites

  • Research Site

    Barrie, Ontario, L4M 7G1

  • Research Site

    Burlington, Ontario, L7R 1E2

  • Research Site

    Courtice, Ontario, L1E 3C3

  • Research Site

    Hamilton, Ontario, L8N 1Y2

  • Research Site

    Mississauga, Ontario, L5M 2V8

  • Research Site

    Oakville, Ontario, L6J 7W5

  • Research Site

    Peterborough, Ontario, K9J 1Z2

  • Research Site

    St. John's, Newfoundland and Labrador, A1C 5B8

  • Research Site

    Victoria, British Columbia, V8V 3P9

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Etanercept via Autoinjector A, Etanercept via Autoinjector B
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Etanercept via Autoinjector ADrug

    Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.

  • Etanercept via Autoinjector BDrug

    Also called Enbrel® SureClick®

    Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.

Study groups in NCT01875991
Study groupRoleWhat they receive
Autoinjector AExperimentalParticipants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
Receives: Drug: Etanercept via Autoinjector A
Autoinjector BExperimentalParticipants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
Receives: Drug: Etanercept via Autoinjector B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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?"

    Measured: Week 8

Secondary outcomes (8)

  1. 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).

    Measured: Baseline and Week 4

  2. 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.

    Measured: At the end of each treatment period; Week 4 and Week 8

  3. 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.

    Measured: At the end of each treatment period; Week 4 and Week 8

  4. 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.

    Measured: At the end of each treatment period; Week 4 and Week 8

  5. 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.

    Measured: At the end of each treatment period; Week 4 and Week 8

  6. 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.

    Measured: At the end of each treatment period; Week 4 and Week 8

  7. 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.

    Measured: At the end of each treatment period; Week 4 and Week 8

  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).

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2013 (estimated)
  2. Study start5 Jun 2013
  3. Primary completion4 Mar 2014
  4. Study completion4 Mar 2014

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01875991
Sponsor's protocol ID
20090176
Status last verified
Aug 2018
First submitted
10 Jun 2013
Last updated
4 Sep 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Etanercept via Autoinjector A and Etanercept via Autoinjector B in people with Rheumatoid Arthritis and Plaque Psoriasis, run by Amgen at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 20 May 2015). 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?

Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01875991.

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 4 Sep 2018.

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