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A Study to Test the Design, Functionality, and Ergonomic Features of the Autoinjector
This study has been completed.
First Received: February 22, 2008   Last Updated: March 24, 2008   History of Changes
Sponsors and Collaborators: Centocor, Inc.
Quintiles
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00643526
  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
and Psoriasis
Ankylosing Spondylitis
Psoriatic Arthritis
Device: Centocor autoinjector is a prefilled, spring-powered, disposable device for the subcutaneous administration of liquid biologic drug products.

Genetics Home Reference related topics: ankylosing spondylitis
MedlinePlus related topics: Ankylosing Spondylitis Psoriasis Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment
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

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.

Estimated Enrollment: 68
Study Start Date: December 2007
Study Completion Date: January 2008
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 autioinjector
  • 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

Study ID Numbers: CR014914
Study First Received: February 22, 2008
Last Updated: March 24, 2008
ClinicalTrials.gov Identifier: NCT00643526     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Spinal Diseases
Autoimmune Diseases
Skin Diseases
Collagen Diseases
Arthritis, Psoriatic
Spondylarthropathy
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases
Musculoskeletal Diseases
Psoriasis
Arthritis
Connective Tissue Diseases
Spondylitis, Ankylosing
Skin Diseases, Papulosquamous
Spondylarthritis
Spondylitis
Ankylosis
Spondylarthropathies

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

ClinicalTrials.gov processed this record on May 07, 2009