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Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo (ADEM)

Primary Purpose

Polyarthritis

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methotrexate
Placebo
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyarthritis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nice University Hospital, Rheumatology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methotrexate

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

pain assessed with EVA

Secondary Outcome Measures

Quality of life survey : SF-36

Full Information

First Posted
January 12, 2010
Last Updated
December 8, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01068405
Brief Title
Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo
Acronym
ADEM
Official Title
Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate
Arm Type
Experimental
Arm Description
Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients with digital arthritis receiving placebo at 10mg/week during 12 months
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months
Primary Outcome Measure Information:
Title
pain assessed with EVA
Time Frame
at screening visit, inclusion visit, first month, and every month during one year
Secondary Outcome Measure Information:
Title
Quality of life survey : SF-36
Time Frame
at inclusion visit, first month, and every month during one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian H ROUX, PhD
Email
roux.cr@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian H ROUX, PhD
Organizational Affiliation
Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nice University Hospital, Rheumatology Department
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian H ROUX, PhD
Phone
0492035491
Email
roux.cr@chu-nice.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34157578
Citation
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.
Results Reference
derived
PubMed Identifier
33501510
Citation
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.
Results Reference
derived

Learn more about this trial

Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo

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