Polyarthritis
Conditions
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
Interventions
DRUGMethotrexate
Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months
DRUGPlacebo
Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain assessed with EVA | at screening visit, inclusion visit, first month, and every month during one year |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life survey : SF-36 | at inclusion visit, first month, and every month during one year |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChristian H ROUX, PhD
Nice University Hospital
Outcome results
None listed