CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
Adalimumab delivered in current syringe +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01163617
NCT01163617Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients

AbbVie (prior sponsor, Abbott)·interventional·Posted Jul 16, 2010·Updated Jul 2, 2018

In Brief

A Phase 2 clinical trial evaluating Adalimumab delivered in current syringe, Adalimumab delivered in Physiolis syringe, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 85 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2010
Enrollment StartMay 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.0 years ago

Interventions

Adalimumab delivered in current syringedevice

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

Adalimumab delivered in Physiolis syringedevice

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

Adalimumab delivered in current autoinjectordevice

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

Adalimumab delivered in Physiolis autoinjectordevice

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