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The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients

NCT01163617 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-07-02

Study results available
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Summary

This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis pre-filled syringe and autoinjector used to administer adalimumab.

Conditions

Interventions

DEVICE

Adalimumab delivered in current syringe

Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

DEVICE

Adalimumab delivered in Physiolis syringe

Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

DEVICE

Adalimumab delivered in current autoinjector

Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously

DEVICE

Adalimumab delivered in Physiolis autoinjector

Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Andrew Payne, PhD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01163617 on ClinicalTrials.gov