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

NCT ID: NCT01882491

Last Updated: 2014-03-04

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

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution for subcutaneous injection

gevokizumab

Group Type EXPERIMENTAL

gevokizumab

Intervention Type DRUG

Solution for subcutaneous injection

Interventions

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Placebo

Solution for subcutaneous injection

Intervention Type DRUG

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 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
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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Huntsville, Alabama, United States

Site Status

Tucson, Arizona, United States

Site Status

Roseville, California, United States

Site Status

Sacramento, California, United States

Site Status

Santa Monica, California, United States

Site Status

Van Nuys, California, United States

Site Status

Denver, Colorado, United States

Site Status

Miami, Florida, United States

Site Status

Pinellas Park, Florida, United States

Site Status

Sarasota, Florida, United States

Site Status

Vero Beach, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Wichita, Kansas, United States

Site Status

Reno, Nevada, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Duncansville, Pennsylvania, United States

Site Status

Austin, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Waco, Texas, United States

Site Status

Charlottesville, Virginia, United States

Site Status

Norfolk, Virginia, United States

Site Status

Franklin, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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X052162

Identifier Type: -

Identifier Source: org_study_id

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