Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis (PASEO)

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.

Study Overview

• Status: Completed
• Conditions: Erosive Hand Osteoarthritis
• Intervention / Treatment: Procedure: Biological sampling; Device: Radiographic evaluation

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • ROUEN university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with hand osteoarthritis; Biological sampling and Radiographic evaluation of patient with erosive and non erosive hand osteoarthritis	Procedure: 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; Device: Radiographic evaluation; Radiographic assessments using Bone Mineral Analyser and Hand MRI will be done in patients with Erosive and non erosive hand Osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis	Assessments done using biological sampling	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Erosion in patients affected by hand osteoarthritis	Number of Erosion in patients affected by hand osteoarthritis is evaluated using Bone Mineral Analyser	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Gilles AVENEL, MD, UH Rouen

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2015
• Primary Completion (Actual): November 17, 2019
• Study Completion (Actual): November 17, 2019

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2014/059/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No