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Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

NCT02378506 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2017-05-15

Study results available
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Summary

Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.

Conditions

  • Arthritis, Rheumatoid

Interventions

BIOLOGICAL

etanercept

50mg subcutaneous, once weekly, 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • Bulgaria
  • Croatia
  • Germany
  • Greece
  • Hungary
  • Poland
  • Serbia
  • Slovakia
  • South Africa

Study Locations

More Related Trials

Entities

Companies

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 NCT02378506 on ClinicalTrials.gov