Osteoarthritis
Conditions
Keywords
Erosive Osteoarthritis, Osteoarthritis, Osteoarthritis of the Hand
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.
Interventions
DRUGPlacebo
Solution for subcutaneous injection
DRUGgevokizumab
Solution for subcutaneous injection
Sponsors
XOMA (US) LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in AUSCAN pain score at Day 84 | Baseline and Day 84 | The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis. |
Countries
United States
Outcome results
None listed