Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | May 2016 |
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
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.
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.
Inclusion Criteria:
- Male or female adults
- RA diagnosis for 6 months
- On stable dose of MTX of 8mg to 25mg per week
- Active disease: greater than 6 tender joints, greater than 6 swollen joints,
C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity
score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2
Exclusion Criteria:
- Use of prednisone greater than 10mg/day
- Use of greater than one non-steroidal anti-inflammatory drug (NSAID)
- Use of biologic therapies for any cause
- Chemistry and hematology values outside protocol specified range
- Positive QuantiFERON-tuberculosis (TB) Gold Test
- Evidence of active lung disease on chest x-ray
- Major systemic infections
- Presence of significant comorbid conditions
- Known allergy to latex
- Women who are pregnant or nursing
We found this trial at
38
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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