CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 640 enrolled
Drug / intervention
Enbrel 50 mg Prefilled Syringe +1 moredevice
Likely dose
Enbrel 50 mg subcutaneously once weeklyAI-extracted
Key inclusion· 3
  • ✓Confirmed diagnosis of rheumatoid arthritis per ACR criteria
  • ✓Eligible for etanercept treatment per SmPC and local guidelines
  • ✓Able and willing to self-inject etanercept
Key exclusion· 3
  • ✕Prior biologic or anti-TNF therapy for RA, including previous etanercept use
  • ✕Sepsis or significant risk of sepsis
  • ✕Current or recent infections (including chronic or localized)

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

Search/NCT00459706
NCT00459706Phase 3Completed
CompareCT.gov

A 3-Month, Randomised, Open-Label, Parallel-Group, Descriptive Study To Explore And Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis

Pfizer·interventional·Posted Apr 12, 2007·Updated Mar 28, 2013

In Brief

A Phase 3 clinical trial evaluating Enbrel 50 mg Prefilled Syringe and Enbrel 50 mg Autoinjector for Rheumatoid Arthritis. Completed, enrolled 640 participants across 113 sites in 9 countries.

Detailed Summary

The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesDenmark, Finland, France, Germany, Italy, Netherlands, Norway, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 12, 2007
Enrollment StartSep 1, 2007
Primary CompletionApr 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.2 years ago

Interventions

Enbrel 50 mg Prefilled Syringedevice

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe

Enbrel 50 mg Autoinjectordevice

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector