Clinical trial: Polymyalgia Rheumatica and Giant Cell Arteritis (NCT02985424)

Eligibility criteria:
Inclusion Criteria:

          -  At least five (A-E) components of the PMR diagnostic criteria, including:

               -  A. Age ≥50 years,

               -  B. Bilateral shoulder or hip pain,

               -  C. Morning stiffness lasting >45 min,

               -  D. Elevated erythrocyte sedimentation rate (ESR),

               -  E. Elevated C-reactive protein (CRP),

               -  F. Disease duration >2weeks, should be met to suspect PMR.

          -  For GCA following criteria's must be seen: Age > 50 years, ESR/CRP > 50, as well as at
             least two symptoms related to vasculitis (scalp tenderness, vision disturbances,
             headache (new or changed), jaw claudication, tenderness of the temporal arteria) if
             patients do not simultaneously have PMR. If the patient is suspected for PMR, one
             cranial symptom is enough to suspect GCA.

        Exclusion Criteria:

          -  Dementia

          -  Inability to communicate in Danish

          -  Infections or malignancy when prednisolone is permanently unsuitable

          -  Contraindication to imaging studies (allergy to contrast materials, reduced kidney
             function, pregnancy and Blood Sugar (BS) >8 mmol/l after 6 hours fasting)

          -  Initiation of steroid treatment before the PET scan

          -  Inability to provide informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 95 Years

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? 1