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NCT Number: NCT02370771

Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the elderly population. Usually considered as a minor illness, it nevertheless leads to an important functional impairment. The mechanism of this disease is still poorly known. Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from which mechanisms may differ.

Methods:

This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in consultation of rheumatology and plastic surgery in Rouen University Hospital.

Two groups of patients will be studied: 20 patients with non erosive subtype of hand osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.

A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.

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Key information

Conditions

Erosive Hand Osteoarthritis

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female gender
  • Less than 70 years old
  • Diagnosis of hand osteoarthritis according to ACR criteria ACR after exclusion of thumb base osteoarthritis:
  • Hand pain, aching or stiffness most of the days during the preceding month
  • Hard tissue enlargement of at least two of 8 selected joints *
  • Hard tissue enlargement of at least two distal interphalangeal joint
  • Swelling of fewer than three metacarpophalangeal joint
  • Deformity of at least one of 10 selected joints * Patients have to fulfil criteria 1, 2 AND 3 + 4 OR 5 * the 8 selected joints are the second and third distal interphalangeal joint and the second and third proximal interphalangeal of both hands Then confirm by experts' committee
  • Exclusively symptomatic treatment
  • For women of child-bearing age, use of an effective contraceptive method
  • French spoken and read

Exclusion criteria

  • Male gender
  • More than 70 years old
  • Hemochromatosis
  • Inflammatory arthritis
  • Cristal induced arthritis
  • Active diseases such as infection or cancer
  • Use of DMARDs
  • Pregnant or breast-feeding woman

Treatment and study plan

biological sampling

Procedure

Biological sampling to identify by label-free proteomic analysis of a combination of serum biomarkers in patients with Erosive and non erosive hand Osteoarthritis

Radiographic evaluation

Device

Radiographic assessments using Bone Mineral Analyser and Hand MRI will be done in patients with Erosive and non erosive hand Osteoarthritis

Primary outcomes

  1. Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis

    Time frame: day 1

    Assessments done using biological sampling

Secondary outcomes

  1. Number of Erosion in patients affected by hand osteoarthritis

    Time frame: Day 1

    Number of Erosion in patients affected by hand osteoarthritis is evaluated using Bone Mineral Analyser

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: PASEO

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2015
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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