Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo
NCT ID: NCT01068405
Last Updated: 2011-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
64 participants
INTERVENTIONAL
2010-03-31
2012-03-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Methotrexate
Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months
Methotrexate
Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months
Placebo
Patients with digital arthritis receiving placebo at 10mg/week during 12 months
Placebo
Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* pain over 40/100
* stable treatment since 4 weeks at least with non-steroid analgesic
* between 45 et 85 years
Exclusion Criteria
* hyaluronic acid injection within the past 6 months
* cortisonic derivated injection within the past 3 months
40 Years
85 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Christian H ROUX, PhD
Role: PRINCIPAL_INVESTIGATOR
Nice University Hospital
Locations
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Nice University Hospital, Rheumatology Department
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Christian H ROUX, PhD
Role: primary
References
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Ferrero S, Wittoek R, Allado E, Cruzel C, Fontas E, Breuil V, Ziegler L, Kremer J, Loeuille D, Roux CH. Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial. Semin Arthritis Rheum. 2021 Aug;51(4):831-838. doi: 10.1016/j.semarthrit.2021.04.016. Epub 2021 May 6.
Allado E, Wittoek R, Albuisson E, Ferrero S, Chenuel B, Chary-Valckenaere I, Roux C, Loeuille D. Topographical analysis of structural lesions between dominant and non-dominant hands in erosive osteoarthritis. Rheumatol Int. 2021 Mar;41(3):617-623. doi: 10.1007/s00296-020-04784-1. Epub 2021 Jan 27.
Other Identifiers
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06-API-07
Identifier Type: -
Identifier Source: org_study_id