Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
Public ClinicalTrials.gov record NCT02115750. 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
A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety. Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.
Study identification
- NCT ID
- NCT02115750
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 647 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
- Apr 30, 2014
- Primary completion
- Sep 30, 2015
- Completion
- Apr 30, 2016
- Last update posted
- Jun 25, 2019
2014 – 2016
United States locations
- U.S. sites
- 37
- U.S. states
- 18
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Elite Clinical Studies | Phoenix | Arizona | 85018 | — |
| Arizona Research Center | Phoenix | Arizona | 85020 | — |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | — |
| Dream Team Clinical Research | Anaheim | California | 92801 | — |
| Advanced Medical Research | Lakewood | California | 90712 | — |
| Pro Health Partners | Long Beach | California | 90808 | — |
| St. Joseph Hospital of Orange | Orange | California | 92868 | — |
| Desert Medical Advances | Palm Desert | California | 92260 | — |
| Kaiser Permanente - CA | Richmond | California | 94801 | — |
| Med Investigators, Inc | Roseville | California | 95661 | — |
| Troum Medical Associates | Santa Monica | California | 90404 | — |
| Inland Rheumatology Clinical Trials Inc | Upland | California | 91786 | — |
| IMMUNOe International Research Centers | Centennial | Colorado | 80112 | — |
| Hope Clinical Research | Kissimmee | Florida | 34741 | — |
| Advanced Medical Research, Inc | Orlando | Florida | 32804 | — |
| Allergy & Rheumatology Associates LLC | St. Petersburg | Florida | 33708 | — |
| HealthPoint Medical Group | Tampa | Florida | 33614 | — |
| Bluegrass Community Research, Inc | Lexington | Kentucky | 40504 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | — |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | — |
| Arthritis Center of Nebraska | Lincoln | Nebraska | 68516 | — |
| Pacific Arthritis Center Medical Group | Omaha | Nebraska | 68198 | — |
| Rheumatoid Arthritis Investigational Network | Omaha | Nebraska | 68198 | — |
| North Shore University Hospital | Great Neck | New York | 11021 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| DJL Clinical Research | Charlotte | North Carolina | 28210 | — |
| PMG Research of Wilmington LLC | Wilmington | North Carolina | 28401 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Low Country Rheumatology | Charleston | South Carolina | 29406 | — |
| Arthritis Clinic | Jackson | Tennessee | 38305 | — |
| Texas Physicians Medical Research Group | Arlington | Texas | 76015 | — |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | — |
| Pioneer Research Solutions Inc | Houston | Texas | 77036 | — |
| Arthritis Northwest Rheumatology PLLC | Spokane | Washington | 99204 | — |
| Rheumatic Disease Center | Glendale | Wisconsin | 53217 | — |
| Gundersen Lutheran Medical Center | Onalaska | Wisconsin | 54650 | — |
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 104 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02115750, 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 Jun 25, 2019 · Synced Sep 11, 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 protocol, eligibility criteria, and contact information for NCT02115750 live on ClinicalTrials.gov.