Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo (ADEM)

Centre Hospitalier Universitaire de Nice

Status and phase: Unknown; Phase 3

Conditions: Polyarthritis

Treatments: Drug: Placebo; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT01068405

06-API-07

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

Methotrexate

Experimental group

Description:

Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months

Treatment:

Drug: Methotrexate

Placebo

Placebo Comparator group

Description:

Patients with digital arthritis receiving placebo at 10mg/week during 12 months

Treatment:

Drug: Placebo