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

NCT ID: NCT02293564

Last Updated: 2015-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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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

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gevokizumab

Group Type EXPERIMENTAL

gevokizumab

Intervention Type DRUG

Solution for subcutaneous injection

Interventions

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gevokizumab

Solution for subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XOMA (US) LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tucson, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Roseville, California, United States

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Sacramento, California, United States

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Santa Monica, California, United States

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Boulder, Colorado, United States

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Denver, Colorado, United States

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Miami, Florida, United States

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Pinellas Park, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

Site Status

Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Hagerstown, Maryland, United States

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Wheaton, Maryland, United States

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Reno, Nevada, United States

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Albuerque, New Mexico, United States

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Raleigh, North Carolina, United States

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Portland, Oregon, United States

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Duncansville, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Franklin, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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X052161

Identifier Type: -

Identifier Source: org_study_id

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