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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01068405
First Posted: February 15, 2010
Last Update Posted: December 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose

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


Condition Intervention Phase
Polyarthritis Drug: Methotrexate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • pain assessed with EVA [ Time Frame: at screening visit, inclusion visit, first month, and every month during one year ]

Secondary Outcome Measures:
  • Quality of life survey : SF-36 [ Time Frame: at inclusion visit, first month, and every month during one year ]

Estimated Enrollment: 64
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methotrexate
Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months
Drug: Methotrexate
Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months
Placebo Comparator: Placebo
Patients with digital arthritis receiving placebo at 10mg/week during 12 months
Drug: Placebo
Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068405


Contacts
Contact: Christian H ROUX, PhD roux.cr@chu-nice.fr

Locations
France
Nice University Hospital, Rheumatology Department Recruiting
Nice, France, 06000
Contact: Christian H ROUX, PhD    0492035491    roux.cr@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Christian H ROUX, PhD Nice University Hospital
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01068405     History of Changes
Other Study ID Numbers: 06-API-07
First Submitted: January 12, 2010
First Posted: February 15, 2010
Last Update Posted: December 9, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors