The standard treatment for Giant Cell arteritis (GCA) is Glucocorticoids(GC), even if GC-related adverse events are commonly occuring. Therefore, other practises for reducing relapses and cumulative GC-doses are needed. Currently, the Interleukin-6-inhibitor tocilizumab is used in combination with GC to achieve higher remission rates and lower cumulative GC-doses. The use of tocilizumab also has some disadvantages. One is the increased susceptibility to infections. On top of that, a long-term follow-up of the phase II study by Villiger et al. showed a 55% relapse-rate after discontinuation of intravenous tocilizumab after a median of five months. Studies have also shown that methotrexate(MTX) in combination with GC was able to prevent relapses and reduce cumulative GC doses. The aim of the study is to evaluate whether MTX is superior to placebo to prevent relapses in subjects with GCA after Remission-Induction Therapy with Glucocorticoids and Tocilizumab. Our hypothesis is that Methotrexate can maintain remission, once stable remission has been induced by GC and Tocilizumab and will prevent the occurrence of relapses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
17,5/15/10 mg Methotrexate subcutaneously
Sodium chloride subcutaneously
Medical Clinic and Polyclinic III Internal medicine Oncology, Hematology University Hospital Bonn, Rheumatology and Clinical Immunology
Bonn, Germany
Time to relapse during the 12 months treatment period
Time frame: 12 months
Cumulative prednisone doses at months 6, 12 and 18
Time frame: 18 months
Number of relapses per patient during the 12 months treatment period
Time frame: 12 months
Time to first, second and third relapse after randomization
Time frame: 18 months
Percentage of patients with a relapse at month 6 and 18 after discontinuation of Tocilizumab
Time frame: 18 months
Health-related quality of life: Short Form-36
The possible score ranges from 0 to 100 points, where 0 points represent the greatest possible health limitation, while 100 points represent no health limitation at all
Time frame: 18 months
Self-reported fatigue : FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue Scale)
The possible score ranges from 0 to 52 points. The higher this value, the better the quality of life.
Time frame: 18 months
Patient Global Assessment of disease activity (PGA)
The possible score ranges from 0 to 100 points, where 0 points represent the lowest disease activity and 100 the highest.
Time frame: 18 months
Patient Assessment of pain
The possible score ranges from 0 to 100 points, where 0 points represent the least pain intensity and 100 the most pain intensity
Time frame: 18 months
Investigator reported Evaluator Global Assessment of disease activity (EGA)
The possible score ranges from 0 to 100 points, where 0 points represent the lowest disease activity and 100 the highest.
Time frame: 18 months
Occurrence of symptoms and signs related to Giant cell arteritis
Time frame: 18 months
Number of vasculitic vessels and change of intima-media-values of temporal and axillary arteries
Time frame: 18 months
Prevalence of aortitis at baseline and month 12 and 18 in MRI
Time frame: 18 months
Proportion of subjects with increased Erythrocyte Sedimentation Rate (>20mm/h) and C-Reactive Protein levels (> 10mg/L)
Time frame: 18 months
Occurrence of adverse events and serious adverse events
Time frame: 12 months
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