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

March 3, 2014 updated by: XOMA (US) LLC

A Phase 2 Proof-of-concept Study of Gevokizumab in Subjects With Inflammatory Erosive Osteoarthritis of the Hand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

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
    • Alabama
      • Huntsville, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Roseville, California, United States
      • Sacramento, California, United States
      • Santa Monica, California, United States
      • Van Nuys, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • Pinellas Park, Florida, United States
      • Sarasota, Florida, United States
      • Vero Beach, Florida, United States
      • West Palm Beach, Florida, United States
    • Kansas
      • Wichita, Kansas, United States
    • Nevada
      • Reno, Nevada, United States
    • North Carolina
      • Raleigh, North Carolina, 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 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 84

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

May 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X052162

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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