Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Centocor, Inc. Identifier:
First received: February 22, 2008
Last updated: November 27, 2014
Last verified: November 2014

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 Phase
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Device: Pre-filled Auto-injector Containing Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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)
Arms Assigned Interventions
Experimental: Injection Site: First Thigh Then Abdomen
Participants will self inject subcutaneously placebo using auto injector at thigh followed by self injection of placebo subcutaneously at abdomen on Day 1.
Device: Pre-filled Auto-injector Containing Placebo
Participants will self-inject placebo subcutaneously at thigh and abdomen.
Experimental: Injection Site: First Abdomen then Thigh
Participants will self inject subcutaneously placebo using auto injector at abdomen followed by self injection of placebo subcutaneously at thigh on Day 1.
Device: Pre-filled Auto-injector Containing Placebo
Participants will self-inject placebo subcutaneously at thigh and abdomen.

Detailed Description:

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


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

Inclusion Criteria:

  • Have the capacity to understand and sign an informed consent form
  • Have one of the following diagnoses: rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis, 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
  • Female participants who are pregnant
  • Are unwilling to complete the study assessments
  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 identifier: NCT00643526

United States, Florida
Miami, Florida, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Sponsors and Collaborators
Centocor, Inc.
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc. Identifier: NCT00643526     History of Changes
Other Study ID Numbers: CR014914
Study First Received: February 22, 2008
Last Updated: November 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthropathies processed this record on February 27, 2015