Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

NCT01068405 | Completed Phase 3

• 1 other identifier: 06-API-07
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Polyarthritis

Outcome Measures

Primary Outcomes (1)

• pain assessed with EVA

  at screening visit, inclusion visit, first month, and every month during one year

Secondary Outcomes (1)

• Quality of life survey : SF-36

  at inclusion visit, first month, and every month during one year

Study Arms (2)

Methotrexate

EXPERIMENTAL

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

Drug: Methotrexate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Methotrexate DRUG

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

Methotrexate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hand arthritis
• pain over 40/100
• stable treatment since 4 weeks at least with non-steroid analgesic
• between 45 et 85 years

You may not qualify if:

• pregnancy or breast feeding women
• hyaluronic acid injection within the past 6 months
• cortisonic derivated injection within the past 3 months

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital, Rheumatology Department

Nice, 06000, France

Location

Related Publications (2)

• 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.

  PMID: 34157578 RESULT

• 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.

  PMID: 33501510 DERIVED

MeSH Terms

Conditions

Arthritis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christian H ROUX, PhD

  Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: February 15, 2010
• Study Start: May 25, 2010
• Primary Completion: June 15, 2014
• Study Completion: October 15, 2018
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FR (1)