Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

NCT02370771 | Completed DMC

• 1 other identifier: 2014/059/HP
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis

  Assessments done using biological sampling

  day 1

Secondary Outcomes (1)

• Number of Erosion in patients affected by hand osteoarthritis

  Day 1

Study Arms (1)

Patient with hand osteoarthritis

EXPERIMENTAL

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

Procedure: Biological sampling; Device: Radiographic evaluation

Interventions

Biological sampling 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

Patient with hand osteoarthritis

Radiographic evaluation DEVICE

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

Patient with hand osteoarthritis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gender
• Less than 70 years old
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Study Officials

• Gilles AVENEL, MD

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 25, 2015
• Study Start: June 9, 2015
• Primary Completion: November 17, 2019
• Study Completion: November 17, 2019
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

FR (1)