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: | 3/1/2014 |
Start Date: | May 2013 |
End Date: | April 2014 |
Contact: | XOMA Clinical Study Center |
Phone: | 510-204-7470 |
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.
in the treatment of 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
23
sites
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