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Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )

NCT03403140 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2018-01-23

No results posted yet for this study

Summary

The purpose of this study is to asses the long term efficacy, safety and immunogenicity of ENERCEPTAN® in combination with Methotrexate for the treatment of patients with rheumatoid arthritis up to 104 weeks

Conditions

Interventions

DRUG

Etanercept

Enerceptan®. Injectable Solution in prefilled syringes Source: GEMABIOTECH S. A. Formulation per unit: 1,0 ml of Enerceptan® contains 50 mg solution of Etanercept /Once a week Methotrexate 15 to 25 mg / Once a week

Sponsors & Collaborators

  • QUID Quality in Drugs and Devices Latin American Consulting SRL

    collaborator OTHER

  • Gema Biotech S.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2018-09-30
Completion
2018-10-31

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 NCT03403140 on ClinicalTrials.gov