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

February 17, 2015 updated by: XOMA (US) LLC

An Open-label Safety Extension Study of Gevokizumab in Active Inflammatory, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Roseville, California, United States
      • Sacramento, California, United States
      • Santa Monica, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Denver, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • Pinellas Park, Florida, United States
      • Tampa, Florida, United States
      • Vero Beach, Florida, United States
      • West Palm Beach, Florida, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Wichita, Kansas, United States
    • Maryland
      • Hagerstown, Maryland, United States
      • Wheaton, Maryland, United States
    • Nevada
      • Reno, Nevada, United States
    • New Mexico
      • Albuerque, New Mexico, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
      • Waco, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Norfolk, Virginia, United States
    • Wisconsin
      • Franklin, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gevokizumab
Drug: gevokizumab
Solution for subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XOMA (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 17, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X052161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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