Clinical trial: Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab (NCT03745586)

Eligibility criteria:
Inclusion Criteria:

          1. Patients with newly onset Giant Cell Arteritis (GCA) with diagnosis of GCA within 4
             weeks before screening visit, satisfying ACR criteria and a CRP > 25 mg/L AND biopsy
             proven GCA (according to ACR criteria) OR a large vessel vasculitis assessed by MR
             Angiography (MRA) or PET/CT (PET).

          2. Previous treatment with GC for a maximum of 10 days since diagnosis of GCA at a
             maximal dose of 60 mg/day of prednisone or equivalent.

          3. Patient's written informed consent.

        Exclusion Criteria:

          1. Rheumatic diseases (except for CPPD/chondrocalcinosis) other than GCA or polymyalgia
             rheumatica (i.e., RA, autoimmune connectivitides, other systemic vasculitides, a.o.)

          2. Chronic use of systemic CS with inability, in the opinion of the investigator, to
             withdraw CS treatment at day 4 according to protocol

          3. Evidence of significant and/or uncontrolled concomitant disease such as, but not
             limited to, cardiovascular disease, nervous system, pulmonary, renal, hepatic,
             endocrine (in particular diabetes mellitus) or gastrointestinal disorders (including
             previous complicated diverticulitis) which, in the investigator's opinion, would
             preclude patient participation or impact the benefit-risk ratio

          4. Any condition or general state of health which, in the Investigator's opinion, would
             preclude participation in the study

          5. Actual or recent myocardial infarction (within the last 3 months before screening
             visit)

          6. Significant cardiac disease (NYHA Class III and IV), known severe chronic obstructive
             pulmonary disease (COPD) (FEV1 < 50% predicted or Functional dyspnea > Grade 3 on the
             MRC Dyspnea Scale) or other significant pulmonary disease

          7. Uncontrolled disease (such as asthma, psoriasis or inflammatory bowel disease) where
             flares are commonly treated with oral or injectable corticosteroids

          8. Known active infection of any kind, or any major episode of infection requiring
             hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or
             completion of oral anti-infectives within 2 weeks before screening visit

          9. History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within
             52 weeks before screening visit

         10. Any surgical procedure, including bone/joint surgery within 8 weeks prior before
             screening visit or planned within the duration of the study

         11. History of serious recurrent or chronic infection (for screening for a chest infection
             a chest radiograph will be performed at screening if not performed within 12 weeks
             before screening visit

         12. Lack of peripheral venous access

         13. Body weight > 150 kg or BMI > 35

         14. Previous treatment with tocilizumab or any other biological agent within last 6 months
             before screening visit; Rituximab within 12 months before screening visit

         15. Treatment with any investigational agent within 28 days of screening visit or 5
             half-lives of the investigational drug (whichever is the longer)

         16. History of severe allergic or anaphylactic reaction to any biologic agent or known
             hypersensitivity to any component of tocilizumab

         17. Receipt of any vaccine within 28 days prior to screening visit (a patient's
             vaccination record and need for immunization prior to receiving tocilizumab/placebo
             must be carefully investigated)

         18. Positive tests for hepatitis B surface antigen (HBsAg) or hepatitis C serology

         19. Positive Quantiferon-TB test for latent Tb without subsequent INH prophylaxis

         20. Patients with active Tb which had to be treated for Tb within 2 years before the
             screening visit

         21. Absolute neutrophil count (ANC) < 2.0 x 103/L, white blood cells < 2.5 x 103/L,
             platelet count < 100,000/L

         22. Hemoglobin < 8.0 g/dL

         23. Concentrations of serum IgG and/or IgM below 5.0 mg/mL and 0.40 mg/mL, respectively

         24. Serum creatinine > 2.0 mg/dL

         25. Alanine aminotransferase (ALT) or aspartate amino-transferase (AST) > 1.5 times the
             upper limit of normal (ULN)

         26. Total bilirubin > 1.5 times the upper limit of normal (ULN)

         27. Triglycerides > 400 mmol/dL (non-fasted) or > 250 mmol/dL (fasted) at screening

         28. Premenopausal status and nursing (definition of postmenopausal status: Female
             participants who are surgically sterilised / hysterectomised or post-menopausal for
             longer than 2 years are not considered as being of child-bearing potential)

         29. Technical implants such as cardiac pacemakers (for MR-angiogram)

         30. Claustrophobia (for MR-angiogram)

         31. Known allergy against the contrast media (Multihance® or Dotarem® as alternative)
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