Open-label Safety Extension Study of Gevokizumab in Erosive Osteoarthritis of the Hand

XOMA

Status: Completed

Conditions: Osteoarthritis

Treatments: Drug: gevokizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02293564

X052161

Details and patient eligibility

About

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.

Enrollment: 312 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

312 participants in 1 patient group

gevokizumab

Experimental group

Treatment:

Drug: gevokizumab