Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab

Stopped early · Phase 4

Conditions studied: Moderate to Severe Rheumatoid Arthritis

In brief

To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.

Key facts

Study ID

NCT01927757

Run by

Amgen

People needed

90

Starts

2013-05-06

Expected to finish

2015-06-11

Last updated by the study team

2018-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide informed consent
• Diagnosed with moderate to severe rheumatoid arthritis for at least 6 months
• Active RA with at least 3 swollen and tender joints
• Failure to respond to a combination treatment of adalimumab and methotrexate (must have taken combination at least 3 months) or loss of a satisfactory response to the combination of adalimumab and methotrexate, which was taken for at least 6 months (if currently taking adalimumab must complete 2 weeks without it prior to starting study drug)
• Negative for hepatitis B and C
• Negative serum and urine pregnancy tests before starting study
• currently taking (stable dose) 15 mg methotrexate weekly for at least 8 weeks/has been taking methotrexate for at least 12 weeks total - lower dose of 10 mg per week is permitted with documented intolerability
• Normal chest X-ray within 3 months
• Negative testing for tuberculosis (TB)

You may not qualify if…

• Class IV RA (wheel-chair or bed-bound)
• Significant concurrent medical conditions, including: (uncontrolled type 1 diabetes, poorly controlled type 2 diabetes, symptomatic heart failure, myocardial infarction in past year, history of unstable angina within past year, uncontrolled hypertension, severe chronic pulmonary disease, major chronic inflammatory or connective tissue disease other than RA, Multiple sclerosis, active malignancy, or history of cancer, alcoholic hepatitis or history of alcoholic liver disease)
• Other inclusion/exclusion criteria may apply

Where it is running

• Research Site — Tuscaloosa, Alabama, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Covina, California, United States
• Research Site — Hemet, California, United States
• Research Site — Murrieta, California, United States
• Research Site — San Diego, California, United States
• Research Site — Victorville, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Brandon, Florida, United States
• Research Site — Dunedin, Florida, United States
• Research Site — Largo, Florida, United States
• Research Site — Palm Harbor, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Lawrenceville, Georgia, United States
• Research Site — Bowling Green, Kentucky, United States
• Research Site — Paducah, Kentucky, United States
• Research Site — Fall River, Massachusetts, United States
• Research Site — Battle Creek, Michigan, United States
• Research Site — Lincoln, Nebraska, United States
• Research Site — Smithtown, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Middleburg Heights, Ohio, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Hixson, Tennessee, United States
• Research Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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