A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients
Public ClinicalTrials.gov record NCT02405780. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease control on methotrexate.
Study identification
- NCT ID
- NCT02405780
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 645 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 10, 2015 (Actual)
- Primary completion
- Jan 18, 2018 (Actual)
- Completion
- Jan 18, 2018 (Actual)
- Last update posted
- Mar 26, 2019
2015 – 2018
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Peoria | Arizona | 85381 | — |
| Research Site | Palm Desert | California | 92260 | — |
| Research Site | Boca Raton | Florida | 33486 | — |
| Research Site | Brandon | Florida | 33511 | — |
| Research Site | Jacksonville | Florida | 32207 | — |
| Research Site | Miami | Florida | 33135 | — |
| Research Site | Sarasota | Florida | 34239 | — |
| Research Site | Shreveport | Louisiana | 71101 | — |
| Research Site | Lansing | Michigan | 48910 | — |
| Research Site | Durham | North Carolina | 27704 | — |
| Research Site | Middleburg Heights | Ohio | 44130 | — |
| Research Site | Duncansville | Pennsylvania | 16635 | — |
| Research Site | Amarillo | Texas | 79124 | — |
| Research Site | Austin | Texas | 78745 | — |
| Research Site | Mesquite | Texas | 75150 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02405780, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2019 · Synced Nov 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02405780 live on ClinicalTrials.gov.