Phase 3
Completed N=647
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT02115750 ↗Enrolled (actual)
647
Serious AEs
5.1%
Results posted
Jun 2019
Primary outcomePrimary: ACR-20 - 20% Improvement According to American College of Rheumatology Criteria — 232; 233 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACR-20 - 20% Improvement According to American College of Rheumatology Criteria |
232; 233 | — |
| SECONDARY ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18 |
48.8; 56.6; 59.4; 71.1; 73.8; 74.6 | — |
| SECONDARY Summary of Change in Tender Joint Count (TJC) by Study Visit |
-9.4; -10.3; -11.8; -13.2; -13.9; -14.7 | — |
| SECONDARY Summary of Change in Swollen Joint Count (SJC) by Study Visit |
-7.1; -7.3; -8.9; -9.5; -10.0; -10.2 | — |
| SECONDARY Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit |
-0.313; -0.266; -0.377; -0.401; -0.444; -0.466 | — |
| SECONDARY Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit |
-18.5; -20.2; -23.4; -27.1; -27.7; -29.3 | — |
| SECONDARY Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit |
-24.1; -24.3; -29.6; -31.7; -33.5; -35.4 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults
- RA (Rheumatoid Arthritis) 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
Data sourced from ClinicalTrials.gov (NCT02115750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.