Osteoarthritis
Conditions
Keywords
Erosive Osteoarthritis, Osteoarthritis, Osteoarthritis of the Hand
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.
Interventions
DRUGgevokizumab
Solution for subcutaneous injection
Sponsors
XOMA (US) LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events | Up to two years | Safety analyses will involve examination of the incidence, severity, and type of treatment-emergent adverse events reported. |
Countries
United States
Outcome results
None listed