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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gevokizumab

Drug

Solution for subcutaneous injection

Primary outcomes

Treatment-emergent adverse events

Time frame: Up to two years

Safety analyses will involve examination of the incidence, severity, and type of treatment-emergent adverse events reported.

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Registry information

Official study title

An Open-label Safety Extension Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

Important dates

Study start: 2013
Primary completion: 2015
First posted: Nov 18, 2014
Registry last updated: Feb 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed