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

December 8, 2011 updated by: Centre Hospitalier Universitaire de Nice

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06000
        • Recruiting
        • Nice University Hospital, Rheumatology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methotrexate
Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months
Drug: Methotrexate
Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months
Placebo Comparator: Placebo
Patients with digital arthritis receiving placebo at 10mg/week during 12 months
Drug: Placebo
Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain assessed with EVA
Time Frame: at screening visit, inclusion visit, first month, and every month during one year
at screening visit, inclusion visit, first month, and every month during one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life survey : SF-36
Time Frame: at inclusion visit, first month, and every month during one year
at inclusion visit, first month, and every month during one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Christian H ROUX, PhD, Nice University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

February 12, 2010

First Posted (Estimate)

February 15, 2010

Study Record Updates

Last Update Posted (Estimate)

December 9, 2011

Last Update Submitted That Met QC Criteria

December 8, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-API-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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