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

• 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: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

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.

Study Design

• 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

Arms and Interventions

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®

Outcome Measures

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).

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01875991
• Other Study ID Numbers: 20090176
• First Posted: June 12, 2013
• Results First Posted: May 20, 2015
• Last Update Posted: September 4, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

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