CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 111 enrolled
Drug / intervention
Commercial Formulation Etanercept +1 moredrug
Likely dose
Commercial Formulation Etanercept 0.98 mLfrom 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/NCT02986139
NCT02986139Phase 3Completed

A Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic Arthritis

Amgen·interventional·Posted Dec 8, 2016·Updated Jul 18, 2019

In Brief

A Phase 3 clinical trial evaluating Commercial Formulation Etanercept and New Formulation Etanercept for Arthritis, Rheumatoid; Arthritis, Psoriatic. Completed, enrolled 111 participants across 30 sites in 2 countries.

Detailed Summary

The primary objective was to assess the injection site pain associated with the new formulation of etanercept compared with commercial etanercept in adults with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) as measured by a visual analog scale (VAS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 8, 2016
Enrollment StartNov 29, 2016
Primary CompletionSep 8, 2017
Study CompletionOct 9, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.6 years ago

Interventions

Commercial Formulation Etanerceptdrug

Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation.

New Formulation Etanerceptdrug

Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation.