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

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.

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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

Phase 2

Primary location

Huntsville, Alabama, 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 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

Treatment and study plan

Placebo

Drug

Solution for subcutaneous injection

gevokizumab

Drug

Solution for subcutaneous injection

Primary outcomes

Percent change from baseline in AUSCAN pain score at Day 84

Time frame: Baseline and Day 84

The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis.

Sponsors and collaborators

Lead sponsor

XOMA (US) LLC

Industry

Registry information

Official study title

A Phase 2 Proof-of-Concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Sep 11, 2012
Registry last updated: Mar 4, 2014

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