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:10/3/2013
Start Date:July 2012
End Date:September 2013
Contact:Rajneesh Nath, MD
Phone:650-388-6308

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A Phase 2 Proof-of-Concept Study of Gevokizumab in Active 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 active 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
13
sites
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Fort Smith, AR
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