Open-label Safety Extension Study of Gevokizumab in Erosive Osteoarthritis of the Hand

Completed · Not applicable

Conditions studied: Osteoarthritis

In brief

The purpose of this study is to evaluate the long-term safety of gevokizumab in the treatment of active inflammatory, erosive osteoarthritis of the hand.

Key facts

Study ID

NCT02293564

Run by

XOMA (US) LLC

People needed

312

Starts

2013-03-01

Last updated by the study team

2015-02-19

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 erosive osteoarthritis (EOA) including: secondary post-traumatic osteoarthritis (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
• 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 — 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 — Boulder, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Hagerstown, Maryland, United States
• Study site — Wheaton, Maryland, United States
• Study site — Reno, Nevada, United States
• Study site — Albuerque, New Mexico, 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

Full record on ClinicalTrials.gov

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