NCT00643526

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for early_phase_1 rheumatoid-arthritis

Timeline
Completed

Started Dec 2007

Shorter than P25 for early_phase_1 rheumatoid-arthritis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

February 22, 2008

Last Update Submit

April 9, 2015

Conditions

Rheumatoid ArthritisPsoriatic ArthritisAnkylosing SpondylitisPsoriasis

Keywords

Rheumatoid arthritisPsoriatic arthritisAnkylosing spondylitisPsoriasisAutoinjector

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1

Secondary Outcomes (1)

  • •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.

    Day 1

Study Arms (2)

Injection Site: First Thigh Then Abdomen

EXPERIMENTAL

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

Injection Site: First Abdomen then Thigh

EXPERIMENTAL

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

Interventions

Pre-filled Auto-injector Containing PlaceboDEVICE

Participants will self-inject placebo subcutaneously at thigh and abdomen.

Injection Site: First Abdomen then ThighInjection Site: First Thigh Then Abdomen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, PsoriaticSpondylitis, AnkylosingPsoriasis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesSkin Diseases, PapulosquamousSkin DiseasesAxial SpondyloarthritisAnkylosis

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 26, 2008

Study Start

December 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(2)