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

Primary Purpose

Erosive Hand Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological sampling
Radiographic evaluation
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Erosive Hand Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with hand osteoarthritis

Arm Description

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

Outcomes

Primary Outcome Measures

Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis
Assessments done using biological sampling

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2015
Last Updated
June 26, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02370771
Brief Title
Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis
Acronym
PASEO
Official Title
Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 9, 2015 (Actual)
Primary Completion Date
November 17, 2019 (Actual)
Study Completion Date
November 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Hand Osteoarthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with hand osteoarthritis
Arm Type
Experimental
Arm Description
Biological sampling and Radiographic evaluation of patient with erosive and non erosive hand osteoarthritis
Intervention Type
Procedure
Intervention Name(s)
Biological sampling
Intervention Description
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
Device
Intervention Name(s)
Radiographic evaluation
Intervention Description
Radiographic assessments using Bone Mineral Analyser and Hand MRI will be done in patients with Erosive and non erosive hand Osteoarthritis
Primary Outcome Measure Information:
Title
Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis
Description
Assessments done using biological sampling
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Number of Erosion in patients affected by hand osteoarthritis
Description
Number of Erosion in patients affected by hand osteoarthritis is evaluated using Bone Mineral Analyser
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles AVENEL, MD
Organizational Affiliation
UH Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France

12. IPD Sharing Statement

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Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

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