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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01068405
First received: January 12, 2010
Last updated: December 8, 2011
Last verified: December 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life survey : SF-36 [ Time Frame: at inclusion visit, first month, and every month during one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01068405     History of Changes
Other Study ID Numbers: 06-API-07
Study First Received: January 12, 2010
Last Updated: December 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on November 20, 2014