Trials / Completed
CompletedNCT02260791
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 728 (actual)
- Sponsor
- Fujifilm Kyowa Kirin Biologics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FKB327 | Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks. |
| DRUG | Humira® | Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks. |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2014-10-09
- Last updated
- 2017-11-28
- Results posted
- 2017-09-20
Locations
100 sites across 12 countries: United States, Bulgaria, Canada, Chile, Czechia, Germany, Peru, Poland, Romania, Russia, Spain, Ukraine
Source: ClinicalTrials.gov record NCT02260791. Inclusion in this directory is not an endorsement.