Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire de Nice

Source Centre Hospitalier Universitaire de Nice
Brief 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

Overall Status Unknown status
Start Date March 2010
Completion Date March 2012
Primary Completion Date March 2012
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
pain assessed with EVA at screening visit, inclusion visit, first month, and every month during one year
Secondary Outcome
Measure Time Frame
Quality of life survey : SF-36 at inclusion visit, first month, and every month during one year
Enrollment 64
Condition
Intervention

Intervention Type: Drug

Intervention Name: Methotrexate

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

Arm Group Label: Methotrexate

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Christian H ROUX, PhD Principal Investigator Nice University Hospital
Overall Contact

Last Name: Christian H ROUX, PhD

Email: [email protected]

Location
Facility: Status: Contact: Nice University Hospital, Rheumatology Department Christian H ROUX, PhD 0492035491 [email protected]
Location Countries

France

Verification Date

December 2011

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Methotrexate

Type: Experimental

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

Label: Placebo

Type: Placebo Comparator

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

Acronym ADEM
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov