Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

Erosive Hand Osteoarthritis Clinical Trial

— PASEO  

Official title:

Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370771
• Other study ID #: 2014/059/HP
• Status: Completed
• Phase: N/A
• Start date: June 9, 2015
• Est. completion date: November 17, 2019

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 17, 2019
• Est. primary completion date: November 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Erosive Hand Osteoarthritis
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis	Assessments done using biological sampling	day 1
Secondary	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