Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

NCT ID: NCT02370771

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-09
• Study Completion Date: 2019-11-17

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.

Conditions

Erosive Hand Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient with hand osteoarthritis

Biological sampling and Radiographic evaluation of patient with erosive and non erosive hand osteoarthritis

Group Type: EXPERIMENTAL

Biological sampling

Intervention Type: 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

Intervention Type: DEVICE

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

Interventions

Biological sampling

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

Intervention Type: PROCEDURE

Radiographic evaluation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles AVENEL, MD

Role: PRINCIPAL_INVESTIGATOR

UH Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2014/059/HP

Identifier Type: -

Identifier Source: org_study_id