Clinical trial: Ustekinumab for the Treatment of Giant Cell Arteritis (NCT02955147)

Eligibility criteria:
Inclusion Criteria: Subjects must meet the following criteria

          1. Able and willing to provide written informed consent and to comply with the study
             protocol

          2. Diagnosis of GCA classified according to the following criteria:

               -  Age 50 years or older

               -  History of erythrosedimentation rate (ESR) ≥ 50 mm/hour or C-reactive protein
                  (CRP) ≥ 10 mg/L

             AND at least one of the following:

               -  Cranial symptoms of GCA

               -  Symptoms of polymyalgia rheumatica (PMR)

             AND at least one of the following:

               -  Temporal artery biopsy revealing features of GCA

               -  Evidence of large-vessel vasculitis by angiography or cross-sectional imaging

          3. Active new-onset or relapsing active disease

        Exclusion Criteria:

          1. Allergies: Subjects who have history of previous severe allergic or anaphylactic
             reaction associated with the administration of monoclonal antibodies or antibody
             fragments.

          2. Systemic infection: Subjects who have an active systemic infection.

          3. Serious infection: Subjects who have had serious infections, or any major episode of
             infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of
             enrollment.

          4. Chronic or recurrent infection: Subjects who have chronic or recurrent bacterial,
             viral, fungal, mycobacterial, or protozoan infection.

          5. Opportunistic infection: Subjects who have, or have had, an opportunistic infection
             within 6 months prior to enrollment.

          6. Subjects who have active hepatitis B or active hepatitis C or a documented history of
             HIV

          7. Latent tuberculosis infection

          8. Malignancy

          9. Subjects with evidence of serious uncontrolled concomitant cardiovascular, nervous
             system, pulmonary, renal, hepatic, endocrine, immunologic, psychiatric or
             gastrointestinal disease that could interfere with participation in the trial
             according to the protocol.

         10. Subjects with transplanted organs (with the exception of a corneal transplant > 3
             months prior to screening)

         11. Major surgery within 8 weeks prior to Screening or planned major surgery within 12
             months after Baseline

         12. Pregnancy

         13. The following laboratory abnormalities

               -  Hemoglobin < 8 gr/dL

               -  Platelets < 100/mm3

               -  White blood cell count (WBC) < 3000/mm3

               -  Absolute neutrophil count < 2000/mm3

               -  Absolute lymphocyte count < 500/mm3

               -  Serum creatinine > 1.4 mg/dL in female subjects and > 1.6 mg/dL in male subjects

               -  Total bilirubin > 2 mg/dL

               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 X upper
                  limit of normal

               -  Positive hepatitis B surface antigen, hepatitis B core antibody or hepatitis C
                  antibody

         14. Prohibited medications:

               -  Subjects who received methotrexate (MTX) > 30 mg weekly, azathioprine,
                  mycophenolate mofetil, cyclophosphamide, chlorambucil, tacrolimus, leflunomide,
                  canakinumab, belimumab, abatacept, tocilizumab, secukinumab, infliximab,
                  etanercept, adalimumab, golimumab, or certolizumab within the 3-month period
                  prior to enrollment.

               -  Subjects who had treatment with any anti-cluster designation antigen (CD)20 agent
                  (e.g., rituximab) within the 9-month period prior to enrolment

               -  Subjects who used any investigational drug within 1 month prior to enrollment or
                  within 5 half-lives of the investigational agent, whichever is longer.

               -  Low dose MTX: Patients on < 30 mg of MTX weekly will be eligible for enrollment
                  after a 2-week washout interval before receiving ustekinumab

               -  Vaccines: Subjects who received any live virus or bacterial vaccinations other
                  than bacille Calmette-Guerin (BCG) within the 3 months before the first
                  administration of the study agent, or are expected to receive any live virus or
                  live bacterial vaccinations during the study, or up to 3 month after the last
                  administration of ustekinumab are not eligible. Subjects who received BCG
                  vaccines within the 12 months before the first administration of the study agent,
                  or are expected to receive BCG vaccines during the study, or up to 12 month after
                  the last administration of ustekinumab are also not eligible.
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