Clinical trial: Timed Release Tablet Prednisone in Polymyalgia Rheumatica (NCT00836810)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of PMR by standard criteria. The Bird criteria will be used. 3 or more
             features are required to make the diagnosis.

               -  Bilateral shoulder pain/stiffness

               -  Duration of symptoms <2/52

               -  Initial ESR >40 mm/h

               -  Stiffness >1 h

               -  Age >65 years

               -  Depression and/or weight loss

               -  Bilateral upper arm tenderness

          -  Are over 50 but less than 85 years old.

          -  No or stable NSAID or analgesic therapy for at least 7 days.

          -  Currently active disease defined by a CRP at least 10mg/L, ESR at least 29mm in one
             hour or PV >1.72

        Exclusion Criteria:

          -  Currently on oral glucocorticoid treatment or taken within 2 months

          -  Parenteral glucocorticoid treatment with the last 2 months

          -  Pregnancy and lactation

          -  Inflammatory diseases such as inflammatory bowel disease, colitis, asthma

          -  Co-existent giant cell arteritis

          -  Other auto-immune diseases

          -  Cancer

          -  Infections, treatment with antibiotics within the past 6 weeks

          -  Significant renal disease (creatinine >150 μmol/L)

          -  Significant hepatic impairment

          -  Participation in a clinical trial within the past 30 days

          -  Working shift employee

          -  Jet lag
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.
Subject must be at most 85 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? Contradiction