Summary:
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.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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
Qualified Participants May Receive:
Compensation for their time/travel.