Clinical trial: Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis (NCT00004686)

Eligibility criteria:
PROTOCOL ENTRY CRITERIA:

        --Disease Characteristics--

        Diagnosis of giant cell arteritis (GCA) by at least one of the following:

          -  Temporal artery biopsy confirming GCA Symptoms of GCA (including new onset (within 6
             months) symptoms of headaches, tenderness of the scalp or the temporal arteries,
             visual loss due to retinal ischemic optic neuropathy or otherwise unexplained tongue
             or jaw pain) and an aortic angiogram that revealed stenotic and/or aneurysmal disease
             of the aorta and its principal branches

          -  Symptoms of polymyalgia rheumatica plus ischemic optic neuropathy, newly identified
             tenderness over a temporal artery, or new onset of tongue or jaw pain

        Westergren erythrocyte sedimentation rate of at least 40 nm in one hour

        --Prior/Concurrent Therapy--

        Endocrine therapy: No greater than 20 days since initiation of prednisone therapy

        Other: No concurrent sulfa drugs or nonsteroidal antiinflammatory drugs

        --Patient Characteristics--

        Hematopoietic:

          -  WBC at least 4,000/mm3

          -  Platelet count at least 120,000/mm3

          -  No acute or chronic liver disease

        Hepatic:

          -  Alkaline phosphatase no greater than 2 times upper limit of normal

          -  No other reproducible abnormal liver function test

        Renal: Creatinine less than 2.0 mg/dL

        Other:

          -  HIV negative

          -  No symptomatic peptic ulcer disease within the last 3 months

          -  Hepatitis B or C antigen negative

          -  No alcohol use in excess of 2 ounces of 100 proof liquor or 1 beer or its equivalent
             per week

          -  No insulin dependent diabetes mellitus plus morbid obesity (greater than 33% over
             ideal body weight)

          -  No recently (less than 6 months) diagnosed malignancy

          -  Not pregnant or nursing

          -  Adequate contraception required of all fertile patients
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