Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand
A Phase 2 Proof-of-Concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand
1 other identifier
interventional
87
1 country
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2012
27 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
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 6, 2012
CompletedFirst Posted
Study publicly available on registry
September 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 4, 2014
March 1, 2014
1.6 years
September 6, 2012
March 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in AUSCAN pain score at 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
Study Arms (2)
Placebo
PLACEBO COMPARATORgevokizumab
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XOMA (US) LLClead
Study Sites (27)
Unknown Facility
Huntsville, Alabama, United States
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
Van Nuys, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Reno, Nevada, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, 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
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2012
First Posted
September 11, 2012
Study Start
July 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 4, 2014
Record last verified: 2014-03