Clinical trial: Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis (NCT00556439)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of GCA or TAK (defined below)

          -  History of active GCA or TAK within the past 2 months

          -  Age of 15 years or older

          -  Willing to use an effective means of birth control throughout the study

        Specific Inclusion Criteria for Participants with GCA:

          -  Participants must meet three of the following five criteria, including either
             Criterion 4 or 5:

               1. Age at disease onset was equal to or greater than 50 years

               2. Disease onset was recent or experiencing a new type of localized pain in the head

               3. Erythrocyte sedimentation rate greater than 40mm in the first hour, as determined
                  using the Westergren method

               4. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or
                  decreased pulsation, unrelated to arteriosclerosis of cervical arteries)

               5. Temporal artery or large vessel biopsy showing vasculitis characterized by a
                  predominance of mononuclear cell infiltration or granulomatous inflammation,
                  usually with multinucleated giant cell or characteristic changes of large vessel
                  stenosis or aneurysm by arteriography

        Specific Inclusion Criteria for Participants with TAK:

          -  Presence of abnormalities that are consistent with TAK identified using arteriography,
             plus at least one of the following criteria:

               1. Age at disease onset was less than 50 years

               2. Pain in the legs or arms

               3. Decreased brachial artery pulse (one or both arteries)

               4. Difference of more than 10mm Hg in blood pressure between the arms

               5. Bruit over subclavian arteries or aorta

        Exclusion Criteria:

          -  Evidence of active infection (including chronic infection)

          -  Pregnant or breastfeeding

          -  HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen

          -  Inability to comply with study guidelines

          -  Inability to provide informed consent

          -  Cytopenia, as defined by a platelet count of less than 80,000/mm3, an absolute
             neutrophil count of less than 1,500/mm3, and hematocrit less than 20%

          -  Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or
             creatinine clearance of 20 ml/min or less

          -  Other uncontrolled disease that could prevent safe study completion

          -  History of any malignant neoplasm except adequately treated basal or squamous cell
             carcinoma of the skin or solid tumors treated with curative therapy and disease-free
             for at least 5 years

          -  Receipt of an investigational agent or device within 30 days prior to study entry

          -  A live vaccination within 4 weeks prior to study entry

          -  Presence of a positive tuberculin skin test with induration of at least 5mm

          -  Radiographic evidence suggestive of tuberculosis

          -  Poor tolerability of blood draws or lack of adequate access to veins for medication
             administration and blood draws

          -  History of treatment with rituximab within 12 months prior to study entry or history
             of treatment with rituximab more than 12 months prior to study entry, where the B
             lymphocyte count has not returned to normal

          -  History of treatment with infliximab within the past 49 days, adalimumab within the
             past 28 days, or etanercept within the past 21 days.

          -  Presence of any of the following diseases or conditions:

               1. Microscopic polyangiitis

               2. Churg-Strauss syndrome

               3. Polyarteritis nodosa

               4. Cogan's syndrome

               5. Behcet disease

               6. Sarcoidosis

               7. Kawasaki disease

               8. Tuberculosis or atypical mycobacterial infection

               9. Deep fungal infection

              10. Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics
                  vasculitis

              11. Cryoglobulinemic vasculitis

              12. Systemic lupus erythematosus

              13. Rheumatoid arthritis

              14. Mixed connective tissue disease or any overlap autoimmune syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 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