A Study to Test the Design, Functionality, and Ergonomic Features of the Autoinjector

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00643526
First received: February 22, 2008
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

The main purpose of this study is to evaluate how well the autoinjector works in a group of people who are likely to use the autoinjector for injecting their medicine in the future. However, no active medicine is given by the autoinjector.


Condition Intervention
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
and Psoriasis
Device: Centocor autoinjector is a prefilled, spring-powered, disposable device for the subcutaneous administration of liquid biologic drug products.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open-Label, Randomized, Validation Study to Establish That the Design, Functionality, and Ergonomic Features of the Autoinjector Conform to Defined User Needs and Intended Use for Self-Administration by Subjects With Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Psoriasis

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • To establish that the autoinjector, as designed, meets defined user needs and intended use for self administration by patients with RA, PsA, AS, and psoriasis.

Secondary Outcome Measures:
  • To establish that the specific training, including the instructional video and the Instructions for Use, are appropriate, easy to understand, and able to be followed and implemented by patients with RA, PsA, AS, and psoriasis.

Enrollment: 68
Study Start Date: December 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The main purpose of this study is to evaluate how well the autoinjector works in a group of people who are likely to use the autoinjector for injecting their medicine in the future. However, no active medicine is given in the autoinjector. This device (called an autoinjector) automatically injects medicine under the skin with a sterile needle, and is similar to other types of autoinjectors currently being used for this purpose. This trial has been designed to make sure that people, who are likely to use this device, are able to self-inject and understand the training material. A total of 68 subjects took part in the study. About half (30 patients) will have either Rheumatoid Arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) and the other half will have psoriasis (a type of skin disease), since this device will be used by patients with one of these diseases to inject their medication. The study is designed to have each patient complete 2 self-injections with the autoinjector in 2 different sites-one in the front of the thigh and one in the abdomen 2 inches away from the navel. The order of the first injection location is decided by randomization. The patient will have an equal chance of having the thigh or the abdomen as the first injection. The study staff will assess the subject's safety prior to the patient leaving the clinic. Two prefilled, 1mL placebo autoinjectors for subcutaneous injection

  Eligibility

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

Inclusion Criteria:

  • Have the capacity to understand and sign an informed consent form
  • Have one of the following diagnoses: RA/PsA/AS, or psoriasis
  • Be willing and able to self-inject

Exclusion Criteria:

  • Have a recent history of (within 6 months prior to study entry) or current diagnosis of a major bleeding or coagulation disorder
  • Have a prior history of a inability to use an autoinjector
  • Have an allergy to latex or any component of the autoinjector
  • Are pregnant
  • Are unwilling to complete the study assessments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643526

Sponsors and Collaborators
Centocor, Inc.
Quintiles
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00643526     History of Changes
Other Study ID Numbers: CR014914
Study First Received: February 22, 2008
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Rheumatologic disorders
Psoriasis
Autoinjector

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Psoriasis
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Ankylosis

ClinicalTrials.gov processed this record on April 23, 2014