A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Methotrexate as Remission Maintenance Therapy after Remission-Induction Therapy with Tocilizumab and Glucocorticoids in Subjects with Giant Cell Arteritis

Conditions

Giant cell arteritis

Brief summary

Time to relapse during the 12 months treatment period

Detailed description

1. Cumulative prednisone doses at months 6, 12 and 18, 2. Number of flares per patient during the 12 months treatment period, Time to first, second and third relapse after randomization, Percentage of patients with a relapse at month 6 and 18 after discontinuation of tocilizumab, 3. Patient reported outcomes including SF-36, FACIT-Fatigue, Patient Global Assessment of Disease Activity (PGA), Patient assessment of pain, 4. Investigator reported outcomes including Eval-uator Global Assessment of disease activity (EGA), 5. Occurrence of symptoms and signs related to GCA, 6. Number of vasculitic vessels and change of intima-media-values during the study, 7. Prevelance of aortitis at baseline and month 12 and 18, 8. Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 10mg/L) at every visit, 9. Occurrence of adverse events and serious adverse events, incidence of glucocorticoid-related adverse events

Kreis L, Dejaco C, Schmidt WA, Németh R, Venhoff N, Schäfer VS.

2024-01-156 citations

10.1186/s13063-024-07905-4

Interventions

DRUGSodiumchloride

DRUGmetex 50 mg/ml Injektionslösung

DRUGFertigspritze

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to relapse during the 12 months treatment period	—

Secondary

Measure	Time frame
1. Cumulative prednisone doses at months 6, 12 and 18, 2. Number of flares per patient during the 12 months treatment period, Time to first, second and third relapse after randomization, Percentage of patients with a relapse at month 6 and 18 after discontinuation of tocilizumab, 3. Patient reported outcomes including SF-36, FACIT-Fatigue, Patient Global Assessment of Disease Activity (PGA), Patient assessment of pain, 4. Investigator reported outcomes including Eval-uator Global Assessment of disease activity (EGA), 5. Occurrence of symptoms and signs related to GCA, 6. Number of vasculitic vessels and change of intima-media-values during the study, 7. Prevelance of aortitis at baseline and month 12 and 18, 8. Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 10mg/L) at every visit, 9. Occurrence of adverse events and serious adverse events, incidence of glucocorticoid-related adverse events	—

Measure

Time frame

1. Cumulative prednisone doses at months 6, 12 and 18, 2. Number of flares per patient during the 12 months treatment period, Time to first, second and third relapse after randomization, Percentage of patients with a relapse at month 6 and 18 after discontinuation of tocilizumab, 3. Patient reported outcomes including SF-36, FACIT-Fatigue, Patient Global Assessment of Disease Activity (PGA), Patient assessment of pain, 4. Investigator reported outcomes including Eval-uator Global Assessment of disease activity (EGA), 5. Occurrence of symptoms and signs related to GCA, 6. Number of vasculitic vessels and change of intima-media-values during the study, 7. Prevelance of aortitis at baseline and month 12 and 18, 8. Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 10mg/L) at every visit, 9. Occurrence of adverse events and serious adverse events, incidence of glucocorticoid-related adverse events

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Countries

Germany

Outcome results

None listed