Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/3/2013 |
Start Date: | July 2012 |
End Date: | September 2013 |
Contact: | Rajneesh Nath, MD |
Phone: | 650-388-6308 |
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.
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
We found this trial at
13
sites
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