Biomarkers in Giant Cells Arteritis

NCT ID: NCT02844023

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-01-14

Brief Summary

Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high dosage corticosteroid therapy.

Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are also issues of becoming dependent on steroid.

So it is important to determine new diagnosis markers and a therapeutic following of giant cells arteritis.

With this study several biomarkers of inflammation will be studied in order to determine if one ore many of them have a good sensitivity and special feature for diagnosis and following of giant cells arteritis.

The main goal is to determine a new diagnosis marker for giant cells arteritis.

Conditions

Giant Cells Arteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with giant gells arteritis

50 patients with giant gells arteritis

Group Type: OTHER

Clinical evaluation

Intervention Type: BEHAVIORAL

With questionnaire.

Paraclinical evaluation

Intervention Type: OTHER

Symptom inflammatory, biomarkers.

Imaging

Intervention Type: DEVICE

Thoraco-abdominal scanner injected or PET scanner if contraindication for scanner.

Ophthalmologic examination

Intervention Type: OTHER

Control patients

50 control patients : blood from French national blood service (EFS)

Group Type: OTHER

Dosage of biomarkers

Intervention Type: BIOLOGICAL

Control patients.

Interventions

Clinical evaluation

With questionnaire.

Intervention Type: BEHAVIORAL

Paraclinical evaluation

Symptom inflammatory, biomarkers.

Intervention Type: OTHER

Imaging

Thoraco-abdominal scanner injected or PET scanner if contraindication for scanner.

Intervention Type: DEVICE

Ophthalmologic examination

Intervention Type: OTHER

Dosage of biomarkers

Control patients.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patient suffering from giant cells arteritis.
• Inclusion while discovery of symptoms, or during relapse.

Exclusion Criteria

• Healthy volunteer
• Treatment with corticosteroid since more than 8 days for a patient suffering from giant cells arteritis, exept for patients under corticosteroid for a polymyalgia rheumatica.
• Other diseases than giant cells arteritis that could introduce an inflammatory symptom, especially a tumoral process in progress or a chronic inflammatory disease (any other one than giant cells arteritis)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence Bouillet, Professor

Role: PRINCIPAL_INVESTIGATOR

Grenoble Hospital University

Locations

UniversityHospitalGrenoble

La Tronche, , France

Countries

France

References

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Other Identifiers

38RC15.198

Identifier Type: -

Identifier Source: org_study_id