Open-label Safety Extension Study of Gevokizumab in Erosive Osteoarthritis of the Hand (NCT02293564) | Clinical Trial Compass
CompletedNot Applicable
Open-label Safety Extension Study of Gevokizumab in Erosive Osteoarthritis of the Hand
United States312 participantsStarted 2013-03
Plain-language summary
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.
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 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