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OpenTrials
Completed

NCT Number: NCT01068405

Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

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

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Key information

Conditions

Polyarthritis Arthritis Joint Diseases Musculoskeletal Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nice University Hospital, Rheumatology Department

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months

Placebo

Drug

Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months

Primary outcomes

  1. pain assessed with EVA

    Time frame: at screening visit, inclusion visit, first month, and every month during one year

Secondary outcomes

  1. Quality of life survey : SF-36

    Time frame: at inclusion visit, first month, and every month during one year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging

Acronym: ADEM

Important dates

Study start
2010
Primary completion
2014
Study completion
2018
First posted
Feb 15, 2010
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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