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Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01901185
First received: May 17, 2013
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept (Enbrel®).


Condition Intervention Phase
Rheumatoid Arthritis
Psoriatic Arthritis
Drug: Etanercept / Autoinjector A
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject Etanercept

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percentage of Successful Self-injections to Total Non-missed Injections [ Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: No ]
    The successful self-injection of etanercept using the Autoinjector A, as evaluated by the percentage of successful injections of the total nonmissed injections administered by participants in the non-health care setting during Weeks 1 to 5. Successful self-injection was assessed by Question 1 in the Participant Self-injection Questionnaire, which was completed by each participant after each self-injection. Successful injection is defined as the Autoinjector A signaling a complete injection and no liquid medication pooled on your skin.


Secondary Outcome Measures:
  • Percentage of Autoinjector A System Failures [ Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: No ]
    The autoinjector A and prefilled syringe (PFS)/cassettes used by the participants were examined at the end of the study by device engineers. System failure was defined as the failure of the Autoinjector A or PFS/cassette to meet the device design requirements during Weeks 1 to 5. The percentage of system failures is reported out of the total number of injection attempts during the study, including multiple attempts per week.

  • Percentage of Errors in Each Step of the Self-injection Process [ Time Frame: Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: No ]
    For all the nonmissed injections recorded on the Participant Self-injection Questionnaire, the percentage of the following steps in the self-injection process that were not successfully completed out of the total nonmissed injections during Weeks 1 to 5 are reported. If multiple attempts were recorded, all the recorded attempts were considered, regardless whether it was a successful attempt or not. • Error Icon lit up (Question 2) • Could not load cassette successfully (Question 3) • Could not remove purple cassette cap successfully (Question 4) • Could not press start button to begin self-injection successfully (Question 5).


Other Outcome Measures:
  • Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a causal relationship with study treatment or the device under study. The definition includes worsening of a pre-existing medical condition. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening • requires or prolongs in-patient hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. An adverse device effect is any adverse event related to the use of a medical device. Adverse device effects include AEs resulting from insufficient or inadequate instructions for use, malfunction of the device, or from use errors (including errors resulting from normal use, reasonably forseeable misuse or from intentional misuse) of the device.


Enrollment: 77
Study Start Date: June 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etanercept / Autoinjector A
Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
Drug: Etanercept / Autoinjector A
Autoinjector A, a hand-held, reusable electromechanical device, and a single-use, disposable cassette preassembled with an etanercept 50-mg liquid prefilled syringe (PFS).
Other Name: Enbrel®

Detailed Description:

Study participants need to have been self-administering etanercept for greater than or equal to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a 4-week screening period and a 5-week treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has diagnosis of RA or PsA and indicated for treatment with etanercept per the current label, based on history.
  • Subject is willing to self-inject per investigator judgement at screening.
  • Subject has no known history of tuberculosis.

Exclusion Criteria:

  • Latex allergy.
  • Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first study 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901185

Locations
United States, Alabama
Research Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Research Site
Peoria, Arizona, United States, 85381
Research Site
Phoenix, Arizona, United States, 85037
United States, California
Research Site
Santa Maria, California, United States, 93454-6945
Research Site
Upland, California, United States, 91786
United States, Colorado
Research Site
Denver, Colorado, United States, 80230
United States, Florida
Research Site
Sarasota, Florida, United States, 34239
Research Site
Tampa, Florida, United States, 33614
United States, Kentucky
Research Site
Paducah, Kentucky, United States, 42003
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, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01901185     History of Changes
Other Study ID Numbers: 20110107
Study First Received: May 17, 2013
Results First Received: November 5, 2014
Last Updated: November 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Autoimmune Diseases
Bone Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014