Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia

Completed · Phase 4 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

Purpose of the study is to determine if Cimzia is safe and effective in subjects who have received previous treatment with a TNF-alpha inhibitor other than Cimzia.

Key facts

Study ID

NCT01147341

Run by

Michael Schiff, MD

People needed

37

Starts

2010-07-01

Expected to finish

2012-01-01

Last updated by the study team

2014-06-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of RA at least 6 months
• Have received treatment with a TNF-alpha inhibitor
• Be receiving Methotrexate (with folic acid)at a dose of at least 10mg/week or another non-biologic DMARD if Methotrexate intolerant *Have at least 6 tender joint and 6 swollen joints*
• Have an CRP greater than or equal to ULN
• Availability of a chest x-ray that shows no evidence of active TB or infection

You may not qualify if…

• Prior exposure to Cimzia
• Prior treatment with B-cell depleting therapy
• No significant response to previous TNF inhibitor
• Congestive heart failure
• Clinically abnormal laboratory tests
• History of cancer
• Active TB

Where it is running

• Rheumatology Associates of N. Alabama — Huntsville, Alabama, United States
• Sun Valley Arthritis Center, Ltd. — Peoria, Arizona, United States
• Arizona Arthritis and Rhematolgy Research — Phoenix, Arizona, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• Westroads Medical Group — Omaha, Nebraska, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Buffalo Rheumatology — Orchard Park, New York, United States
• Rheumatology Associates of Long Island — Smithtown, New York, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Mountain State Clinical Research — Clarksburg, West Virginia, United States
• Rheumatology and Immunotherapy Center — Oak Creek, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.