Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

Not Applicable

Completed

• Conditions: Erosive Hand Osteoarthritis
• Interventions: Procedure: Biological sampling; Device: Radiographic evaluation

• Registration Number: NCT02370771
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-25
• Study Start: 2015-06-09
• Primary Completion: 2019-11-17
• Study Completion: 2019-11-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Female gender

• Less than 70 years old

• Diagnosis of hand osteoarthritis according to ACR criteria ACR after exclusion of thumb base osteoarthritis:

  1. Hand pain, aching or stiffness most of the days during the preceding month
  2. Hard tissue enlargement of at least two of 8 selected joints *
  3. Hard tissue enlargement of at least two distal interphalangeal joint
  4. Swelling of fewer than three metacarpophalangeal joint
  5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with hand osteoarthritis	Biological sampling	Biological sampling and Radiographic evaluation of patient with erosive and non erosive hand osteoarthritis
Patient with hand osteoarthritis	Radiographic evaluation	Biological sampling and Radiographic evaluation of patient with erosive and non erosive hand osteoarthritis

Primary Outcome Measures

Name	Time	Method
Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis	day 1	Assessments done using biological sampling

Secondary Outcome Measures

Name	Time	Method
Number of Erosion in patients affected by hand osteoarthritis	Day 1	Number of Erosion in patients affected by hand osteoarthritis is evaluated using Bone Mineral Analyser

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France