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Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis

NCT03332719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2017-11-06

No results posted yet for this study

Summary

The purpose of this study is to asses the compared efficacy, safety and immunogenicity of ENERCEPTAN® with ENBREL® in combination with Methotrexate for the treatment of patients with rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

Etanercept

DRUG

Methotrexate

Sponsors & Collaborators

  • QUID Quality in Drugs and Devices Latin American Consulting SRL

    collaborator OTHER

  • Gema Biotech S.A.

    lead INDUSTRY

Principal Investigators

  • Jorge Velasco, MD · Instituto Médico CER

  • Maria de los Angeles Correa, MD · PAMPA

  • Maria Alicia Lazaro, MD · IARI

  • Rodolfo Pardo Hidalgo, MD · CER San Juan

  • Daniel Siri, MD · CAICI

  • Alberto Jorge Spindler, MD · Centro Médico Privado de Reumatología

  • Ingrid Strusberg, MD · Centro Reumatologico Strusberg

  • Patricio Tate, MD · OMI

  • Horacio Oscar Venarotti, MD · Atención Integral en Reumatología

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-03-31
Completion
2017-09-30

Countries

  • Argentina

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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 NCT03332719 on ClinicalTrials.gov