Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of active inflammatory, erosive osteoarthritis of the hand.

Key facts

Study ID

NCT01683396

Run by

XOMA (US) LLC

People needed

87

Starts

2012-07-01

Expected to finish

2014-02-01

Last updated by the study team

2014-03-04

Who can join

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

You may qualify if…

• Diagnosis of hand osteoarthritis
• Joint tenderness and/or redness
• At least one erosion by X-ray (as determined by the central reader)
• Contraceptive measures adequate to prevent pregnancy during the study

You may not qualify if…

• History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
• History of gout, pseudogout, or hemochromatosis
• History of allergic or anaphylactic reactions to monoclonal antibodies
• History of recurrent or chronic systemic infections
• Known allergy to acetaminophen
• Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — Santa Monica, California, United States
• Study site — Van Nuys, California, United States
• Study site — Denver, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Wichita, Kansas, United States
• Study site — Reno, Nevada, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Waco, Texas, United States
• Study site — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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