Clinical trial: Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering (NCT04012905)

Eligibility criteria:
Inclusion Criteria:

          -  Age ≥ 50 years

          -  Patient with temporal arteritis giant cell match 2 of the 4 criteria of the American
             College of Rheumatology (ACR) that given :

               -  a temporal artery biopsy compatible with a diagnosis of CAG or

               -  an abdominal thoracic aortitis diagnosed by Angio CT, MR angiography or PET
                  scanner or

               -  Echo Doppler compatible with a diagnosis of CAG

          -  Oral corticosteroid treatment started up to 14 days, the initial dose is less or equal
             to 1 mg / Kg

          -  Patient wo has given its written consent Patient affiliated with a social security

        Exclusion Criteria:

        Subjects checking one of the criteria for non-inclusion may be eligible to participate in
        the research. These criteria may include:

          -  Early treatment of CAG disease with a dose> 1 mg / kg whatever the duration

          -  Corticosteroids already started over 14 days

          -  Giant arteritis cell on relapse

          -  dementia syndrome

          -  No compliant patient

          -  Patients who live more than 150 km from the investigation center

          -  Person under judicial protection, guardianship

          -  Hypersensitivity to prednisone or any of its excipients

          -  Infection requiring an systemic treatment

          -  Evolutive viroses (Hepatitis, Herpes, varicella-zoster virus)

          -  Immunization with live vaccines / mitigated during the 8 weeks preceding inclusion

          -  Pregnancy, breastfeeding women or women of childbearing potential not using
             contraception
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? Entailment