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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: gevokizumab

• Registration Number: NCT02293564
• Lead Sponsor: XOMA (US) LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-18
• Primary Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-17
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gevokizumab	gevokizumab	-

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events	Up to two years	Safety analyses will involve examination of the incidence, severity, and type of treatment-emergent adverse events reported.