Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

Completed · Phase 4 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).

Key facts

Study ID

NCT01313208

Run by

Amgen

People needed

210

Starts

2011-03-01

Expected to finish

2013-05-01

Last updated by the study team

2017-02-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Tuscaloosa, Alabama, United States
• Research Site — Peoria, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Encino, California, United States
• Research Site — Hemet, California, United States
• Research Site — Inglewood, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Murrieta, California, United States
• Research Site — Santa Maria, California, United States
• Research Site — Tustin, California, United States
• Research Site — Upland, California, United States
• Research Site — Victorville, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Sebring, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Meridian, Idaho, United States
• Research Site — Springfield, Illinois, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Frederick, Maryland, United States
• Research Site — Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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