drugset / Trial / NCT01068405

Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

NCT01068405 ↗

Phase 3 Completed 64 enrolled Centre Hospitalier Universitaire de Nice
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2010-05-25
Primary completion
2014-06-15
Completion
2018-10-15

Outcome

Missed primary endpoint

paper At 3 months, there was no significant difference in the mean decrease in the pain VAS score (mm) (MTX: 21.1 [standard deviation, 27.4], placebo: 11.7 [24.3]; p = 0.2). PMID 34157578 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 10 mg —