Trials / Completed
CompletedNCT02744755
Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis
A Randomized, Double-blind, Parallel-group, Multicenter Study to Demonstrate Similar Efficacy and to Compare Safety and Immunogenicity of GP2017 and Humira® in Patients With Moderate to Severe Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 353 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis
Detailed description
The purpose of this study is to demonstrate similar efficacy and safety of GP2017 and US-licensed Humira® in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to Disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Adalimumab - GP2017 | Adalimumab - GP2017 |
| BIOLOGICAL | Adalimumab - US licensed Humira | Adalimumab - US licensed Humira |
Timeline
- Start date
- 2016-03-31
- Primary completion
- 2017-01-31
- Completion
- 2017-09-26
- First posted
- 2016-04-20
- Last updated
- 2018-12-19
- Results posted
- 2018-12-19
Locations
83 sites across 13 countries: United States, Czechia, Germany, Hungary, Italy, Malaysia, Mexico, Poland, Romania, Russia, Serbia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02744755. Inclusion in this directory is not an endorsement.