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Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis

NCT02638259 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2018-09-19

Study results available
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Summary

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).

Conditions

Interventions

DRUG

GP2015

Enbrel comparator

Sponsors & Collaborators

Principal Investigators

  • Arnd Schwebig, MD · Global Program Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-21
Primary Completion
2016-12-29
Completion
2017-06-12

Countries

  • United States
  • Bulgaria
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT02638259 on ClinicalTrials.gov