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

XOMA

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis

Treatments

Drug: Placebo

Drug: gevokizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01882491

X052162

Details and patient eligibility

About

The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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