- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01683396
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 Active 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 active inflammatory, erosive osteoarthritis of the hand.
Study Overview
Study Type
Interventional
Enrollment (Actual)
87
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
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Alabama
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Huntsville, Alabama, United States
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Arizona
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Tucson, Arizona, United States
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Arkansas
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Little Rock, Arkansas, United States
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California
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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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Van Nuys, California, United States
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Colorado
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Denver, Colorado, United States
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Florida
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Miami, Florida, United States
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Pinellas Park, Florida, United States
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Sarasota, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Kansas
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Wichita, Kansas, United States
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Nevada
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Reno, Nevada, United States
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New York
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New York, New York, United States
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Rochester, New York, United States
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North Carolina
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Raleigh, North Carolina, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Duncansville, Pennsylvania, United States
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Texas
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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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Virginia
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Wisconsin
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Franklin, Wisconsin, United States
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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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
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Solution for subcutaneous injection
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EXPERIMENTAL: gevokizumab
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Solution for subcutaneous injection
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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
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The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis.
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Baseline and Day 84
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2012
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
February 1, 2014
Study Registration Dates
First Submitted
September 6, 2012
First Submitted That Met QC Criteria
September 10, 2012
First Posted (ESTIMATE)
September 11, 2012
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- X052160
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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