Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autoinjector A | Experimental | Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks. |
|
| Autoinjector B | Experimental | Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept via Autoinjector A | Drug | Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe. |
| 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 |
| 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 |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Huntsville | Alabama | 35801 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Randomization was stratified by disease state (RA and PsO). Each participant served as his or her own control in this crossover study.
Adults (≥ 18 years) with moderate to severe rheumatoid arthritis (RA) or plaque psoriasis (PsO) and candidates for treatment with etanercept (Enbrel) in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept.
First patient enrolled on 05 June 2013; last patient enrolled 03 January 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Autoinjector A / Autoinjector B | Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment. |
| FG001 | Autoinjector B / Autoinjector A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Etanercept via Autoinjector B | Drug | Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe. |
|
|
| 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 |
| Tuscaloosa |
| Alabama |
| 35406 |
| United States |
| Research Site | Glendale | Arizona | 85304 | United States |
| Research Site | Scottsdale | Arizona | 85258 | United States |
| Research Site | Hot Springs | Arkansas | 71913 | United States |
| Research Site | San Diego | California | 92108 | United States |
| Research Site | San Ramon | California | 94583 | United States |
| Research Site | Santa Maria | California | 93454-6945 | United States |
| Research Site | Tustin | California | 92780 | United States |
| Research Site | Denver | Colorado | 80230 | United States |
| Research Site | Dunedin | Florida | 34698 | United States |
| Research Site | Tampa | Florida | 33614 | United States |
| Research Site | Overland Park | Kansas | 66215 | United States |
| Research Site | Louisville | Kentucky | 40217 | United States |
| Research Site | Frederick | Maryland | 21702 | United States |
| Research Site | Lansing | Michigan | 48910 | United States |
| Research Site | Lincoln | Nebraska | 68516 | United States |
| Research Site | Orchard Park | New York | 14127 | United States |
| Research Site | Bismarck | North Dakota | 58502 | United States |
| Research Site | Dayton | Ohio | 45417 | United States |
| Research Site | Oklahoma City | Oklahoma | 73103 | United States |
| Research Site | Duncansville | Pennsylvania | 16635 | United States |
| Research Site | Wyomissing | Pennsylvania | 19610 | United States |
| Research Site | Charleston | South Carolina | 29414 | United States |
| Research Site | Hixson | Tennessee | 37343 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Clarksburg | West Virginia | 26301 | United States |
| Research Site | Victoria | British Columbia | V8V 3P9 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1C 5B8 | Canada |
| Research Site | Barrie | Ontario | L4M 7G1 | Canada |
| Research Site | Burlington | Ontario | L7R 1E2 | Canada |
| Research Site | Courtice | Ontario | L1E 3C3 | Canada |
| Research Site | Hamilton | Ontario | L8N 1Y2 | Canada |
| Research Site | Mississauga | Ontario | L5M 2V8 | Canada |
| Research Site | Oakville | Ontario | L6J 7W5 | Canada |
| Research Site | Peterborough | Ontario | K9J 1Z2 | Canada |
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment. |
| Received Etanercept in Period 1 |
|
| Received Etanercept in Period 2 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Autoinjector A / Autoinjector B | Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment. |
| BG001 | Autoinjector B / Autoinjector A | Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Disease State | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?" | The primary analysis set consisted of all randomized participants who received at least 1 injection of Eetanercept with each autoinjector and indicated a preference for an autoinjector in the Subject Preference Questionnaire. N = number of participants with RA and PsO respectively. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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). | Full analysis set, which included all randomized participants. "n" indicates the number of participants with available data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set with available data | Posted | Number | percentage of participants | At the end of each treatment period; Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set with available data | Posted | Number | percentage of participants | At the end of each treatment period; Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set with available data | Posted | Number | percentage of participants | At the end of each treatment period; Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set with available data | Posted | Number | percentage of participants | At the end of each treatment period; Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set with available data | Posted | Number | percentage of participants | At the end of each treatment period; Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set with available data | Posted | Number | percentage of participants | At the end of each treatment period; Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Primary Analysis Set | Posted | Number | percentage of participants | Week 8 |
|
|
12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autoinjector A | Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks. | 9 | 211 | 12 | 211 | ||
| EG001 | Autoinjector B | Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks. | 2 | 210 | 6 | 210 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Other |
|
| Not Hispanic or Latino |
|
| Plaque Psoriasis |
|
| Title | Measurements |
|---|---|
|
|
|
| Participants |
|
|
|
|
|
|
|
|