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



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/1/2014
Start Date:May 2013
End Date:April 2014
Contact:XOMA Clinical Study Center
Phone:510-204-7470

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A Phase 2 Proof-of-concept Study of Gevokizumab in Subjects With Inflammatory Erosive Osteoarthritis of the Hand

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


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
23
sites
28
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Van Nuys, CA
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Austin, TX
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Charlottesville, VA
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Dallas, TX
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817
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Denver, CO
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Franklin, WI
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Huntsville, AL
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Miami, FL
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Norfolk, VA
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2125
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Pinellas Park, FL
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2214
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Raleigh, NC
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387
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Reno, NV
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368
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Roseville, CA
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364
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Sacramento, CA
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San Antonio, TX
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26
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Santa Monica, CA
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Sarasota, FL
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427
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Tucson, AZ
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Vero Beach, FL
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Waco, TX
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2304
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West Palm Beach, FL
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1182
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Wichita, KS
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