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Keep this study
Lead
Amgen
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female ≥18 and ≤80 years of age at time of screening
Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months
Moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) \> 3.2 and ≤ 5.1
Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees)
Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
You may not be if
Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
Class IV rheumatoid arthritis according to ACR revised response criteria
Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
Previously used more than one experimental biologic DMARD. Patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product
Previously used more than one commercially available biologic DMARD. Subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples:
No more than 4 injections of adalimumab
No more than 8 (50 mg) injections of etanercept
No more than 2 infusions of infliximab
No more than 2 infusions of abatacept
Additional inclusion (exclusion) criteria may apply
Clareo Health | Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
