Last updated: September 28, 2021
Sponsor: Centre Hospitalier Universitaire Dijon
Overall Status: Active - Recruiting
Phase
N/A
Condition
Connective Tissue Diseases
Polymyalgia Rheumatica (Pmr)
Collagen Vascular Diseases
Treatment
N/AClinical Study ID
NCT03313102
Samson APJ 2016
Ages > 51 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: PATIENTS
- Patients who have provided written consent
- Patients with national health insurance cover
- Age > 50 years
- Patients with Horton disease at the diagnosis, before any treatment. Horton disease is defined by ACR criteria [7], the diagnosis is made in the presence of 3of the following 5 criteria:
- Age at the onset of the disease of 50 years or older
- Recent-onset localized headache
- Temporal artery tenderness or decreased temporal artery pulse
- Erythrocyte sedimentation rate (ESR) greater than 50 mm in the first hour (or CRP>20mg/L)
- Positive temporal artery biopsy (TAB) showing vasculitis with infiltration ofmononuclear cells or granulomatous inflammation with or without giant cells. Control groups: Control Group 1: Healthy subjects Healthy subjects will be matched for age and sex withpatients. They will be recruited in Dijon only. They will be healthy volunteers recruitedamong blood donors, voluntary hospital personnel (nurses, doctors and secretaries) andpatients without an infectious or inflammatory disease, or cancer or auto-immune disease (CRP<5mg/L) recruited in the departments of investigators at the CHU of Dijon Burgundy. Control Group 2: (PPR without ACG)
- Patient with oral consent
- Patient affiliated to a social security system
- Age > 50 years old
- Patient with PPR at diagnosis, before corticosteroid treatment
- No ACG (see protocol definition) Control Group 3: (active infection)
- Patient with oral consent
- Patient affiliated to a social security system
- Age > 50 years old
- Inflammatory syndrome (CRP > 10 mg/L and fibrinogen> 4 g/L or CRP > 10 mg/L and VS > 30 mm/h) explained by a infectious syndrome defined by the association:
- a fever ≥ 38°C, hypothermia < 35°C or fever reported by the patient within 72 hoursbefore inclusion
- at least 1 associated clinical and/or radiological sign to an organ infection, forexample: pneumopathy, urinary infection, bacterial dermohypodermatitis, infectiondigestive (non-exhasutive list)
- in the absence of an explanation of the inflammatory syndrome by another cause such asan inflammatory disease or evolutive neoplastic
Exclusion
Exclusion Criteria:
- Adults under guardianship
- Pregnant or breast-feeding women
- Patients who have been treated with corticosteroids or immunosuppressants in the monthpreceding inclusion
- Patients treated with chemotherapy, immunosuppressants or biotherapy
- Contra-indication for corticosteroid therapy
- Weight <41 kg or Hg <7g/l
Study Design
Total Participants: 60
Study Start date:
November 16, 2017
Estimated Completion Date:
November 30, 2024
Connect with a study center
CHU Dijon Bourgogne
Dijon, 21079
FranceActive - Recruiting
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