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