erosive hand osteoarthritis
Conditions
Interventions
intervention group:vunakizumab 120 mg (1 mL)
control group:placebo (1 mL of sterile saline)
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 30-80 years. 2. Pain in the joints of the study hand for most days in the past month. 3. Pain score in the study hand of at least 40mm on a 100mm Visual Analogue Scale (VAS) on average over the past 7 days 4. Hand osteoarthritis (OA) diagnosis in the study hand that fulfils the American College of Rheumatology Criteria. 5. Radiographic OA (Kellgren and Lawrence grade >=2) in at least one joint of the study hand as recommended by the Osteoarthritis Research Society International (OARSI) clinical trials guidelines for hand OA 18. 6. At least one distal interphalangeal (DIP) joint or proximal interphalangeal (PIP) joint in the 2nd-5th fingers of the study hand with radiographic (X-ray) pre-erosive (J phase) or erosive (E phase) status according to Verbruggen-Veys anatomical phase system 19. 7. Willingness to abstain from pain relief medications (except paracetamol) and other prohibited medications over the study period.
Exclusion criteria
Exclusion criteria: 1. History of inflammatory arthritis or crystal related arthritis, skin psoriasis, or fibromyalgia. 2. Positive anti-cyclic citrullinated peptides or rheumatoid factor. 3. Concurrent prednisolone/prednisone use or injection of corticosteroid in the past 3 months. 4. Concurrent use of conventional disease-modifying therapy or biological therapy for hand OA. 5. Surgery on the study hand in the past 12 months or planned within the next nine months. 6. Contraindications to biological therapy (1) Cancers, including skin cancer. (2) Serious infections requiring hospitalisation in the past 5 years. (3) Active infection with Hepatitis B, active tuberculosis, past infection with Hepatitis C or HIV (to be checked during screening) (4) Personal or family history of inflammatory bowel disease 7. Contraindication to MRI. 8. Pregnancy/breastfeeding. 9. Serious or unstable concurrent medical condition likely to impact participation in the trial (Such as active infection, unstable ischemic heart disease, severe heart failure, recent stroke, or uncontrolled diabetes mellitus). 10. Inability to provide informed consent or complete written questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS (0-100 mm) pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Index for Hand Osteoarthritis;The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire;Health Assessment Questionnaire;Grip strength;structural progression measured by X ray;structural progression measured by MRI;VAS (0-100 mm) pain; | — |
Countries
China
Contacts
Public ContactKai Fu
Shanghai Sixth People's Hospital
Outcome results
None listed