Trials / Completed
CompletedNCT02638259
Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis
A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 376 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
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). In addition, data on the safety profiles of both products, including immunogenicity and local tolerability at the injection sites, will be collected and compared. An additional study objective is to identify any potential risk of the transition from Enbrel to GP2015 in terms of general safety and immunogenicity in RA patients
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GP2015 | Enbrel comparator |
Timeline
- Start date
- 2015-02-21
- Primary completion
- 2016-12-29
- Completion
- 2017-06-12
- First posted
- 2015-12-23
- Last updated
- 2018-09-19
- Results posted
- 2018-02-23
Locations
92 sites across 16 countries: United States, Bulgaria, Czechia, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Russia, Serbia, Slovakia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02638259. Inclusion in this directory is not an endorsement.