Overview

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

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
XOMA (US) LLC
Criteria
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