Open-label Safety Extension Study of Gevokizumab in Erosive Osteoarthritis of the Hand
An Open-label Safety Extension Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand
1 other identifier
interventional
312
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 11, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedFebruary 19, 2015
February 1, 2015
1.8 years
November 11, 2014
February 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-emergent adverse events
Safety analyses will involve examination of the incidence, severity, and type of treatment-emergent adverse events reported.
Up to two years
Study Arms (1)
gevokizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XOMA (US) LLClead
Study Sites (28)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Boulder, Colorado, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Hagerstown, Maryland, United States
Unknown Facility
Wheaton, Maryland, United States
Unknown Facility
Reno, Nevada, United States
Unknown Facility
Albuerque, New Mexico, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Waco, Texas, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Franklin, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2014
First Posted
November 18, 2014
Study Start
March 1, 2013
Primary Completion
January 1, 2015
Last Updated
February 19, 2015
Record last verified: 2015-02