Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo
- Registration Number
- NCT01068405
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.
At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis.
In this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- hand arthritis
- pain over 40/100
- stable treatment since 4 weeks at least with non-steroid analgesic
- between 45 et 85 years
Exclusion Criteria
- pregnancy or breast feeding women
- hyaluronic acid injection within the past 6 months
- cortisonic derivated injection within the past 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methotrexate Methotrexate Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months Placebo Placebo Patients with digital arthritis receiving placebo at 10mg/week during 12 months
- Primary Outcome Measures
Name Time Method pain assessed with EVA at screening visit, inclusion visit, first month, and every month during one year
- Secondary Outcome Measures
Name Time Method Quality of life survey : SF-36 at inclusion visit, first month, and every month during one year
Trial Locations
- Locations (1)
Nice University Hospital, Rheumatology Department
🇫🇷Nice, France