Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

Polyarthritis Clinical Trial

— ADEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01068405
• Other study ID #: 06-API-07
• Status: Recruiting
• Phase: Phase 3
• First received: January 12, 2010
• Last updated: December 8, 2011
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Christian H ROUX, PhD
• Email: roux.cr[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Polyarthritis

Intervention

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

Locations

Country	Name	City	State
France	Nice University Hospital, Rheumatology Department	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain assessed with EVA		at screening visit, inclusion visit, first month, and every month during one year	No
Secondary	Quality of life survey : SF-36		at inclusion visit, first month, and every month during one year	No