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: January 21, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to assess the ability of people with Rheumatoid Arthritis or Psoriatic Arthritis to use an experimental autoinjector to self inject etanercept (Enbrel®). 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.


Condition Intervention Phase
Rheumatoid Arthritis
Psoriatiric Arthritis
Drug: Etanercept
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 Electromechancial Autoinjector to Self-inject Etanercept

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Successful self-injection of etanercept using Autoinjector A, as evaluated by the proportion of successful injections of the total nonmissed injections administered by subjects in the non-health care setting [ Time Frame: Weekly for 5 weeks at Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Autoinjector A system failure when the Autoinjector A system is operated within intended use [ Time Frame: Weekly for 5 weeks at Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: No ]
  • Proportions of the unsuccessful steps in the self-injection process for unsuccessful injections, as assessed by the Participant Self-injection Questionnaire (Questions 2 to 5). [ Time Frame: Weekly for 5 weeks at Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of subject reports of adverse events, serious adverse events and adverse device events [ Time Frame: Weekly for 5 weeks at Week 1, Week 2, Week 3, Week 4 and Week 5 ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: June 2013
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autoinjector A Drug: Etanercept

  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
Last Updated: January 21, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 18, 2014