Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand (NCT01683396) | Clinical Trial Compass
CompletedPhase 2
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand
United States87 participantsStarted 2012-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Percent change from baseline in AUSCAN pain score at Day 84