Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02370771
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Rouen
• Public title: Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis PASEO
• Scientific title: Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis
• Date of first enrolment: June 9, 2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02370771
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Gilles AVENEL, MD
• Affiliation: UH Rouen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Erosive Hand Osteoarthritis

Intervention(s)

Device: Radiographic evaluation

Procedure: Biological sampling

Primary Outcome(s)

Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis [Time Frame: day 1]

Secondary Outcome(s)

Number of Erosion in patients affected by hand osteoarthritis [Time Frame: Day 1]

Secondary ID(s)

2014/059/HP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors