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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01068405
Other study ID # 06-API-07
Secondary ID
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


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
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