Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-Guided Dose Reduction in Patients with Rheumatoid Arthritis: The RITUXERA Trial.

Conditions

Rheumatoid arthritis

Brief summary

Comparison between both study arms of disease impact (Rheumatoid Arthritis Impact of Disease (RAID) questionnaire) over 104 weeks.

Detailed description

Comparison between both study arms of disease activity (AUC of the Disease Activity Score in 28-joints - C-reactive Protein (DAS28-CRP)) over 104 weeks., Cumulative dose of rituximab in the two trial arms over 104 weeks., Cumulative dose of glucocorticoids in the two trial arms over 104 weeks., Disease activity (AUC of the Simplified Disease Activity Index (SDAI)) in the two study arms over 104 weeks., Maintenance of disease control (DAS28-CRP ≤3.2) in both study arms., Rituximab drug retention rate in both study arms., Proportion of patients achieving a good/moderate European League Against Rheumatism (EULAR) response 12 weeks after treatment with rituximab in both study arms., Proportion of patients who tapered the dose of rituximab below 1 x 1000 mg IV in the experimental arm., Mean/median interval between administrations of rituximab in the active control arm., Proportion of patients with serious adverse events/reactions in both study arms., Proportion of patients with serious infections in both study arms.

De Meyst E, Bertrand D, Joly J, Doumen M, Marchal A, Thelissen M, Neerinckx B, Westhovens R, Verschueren P.

2024-10-151 citations

10.1186/s13063-024-08542-7

Interventions

DRUGRixathon 100 mg concentrate for solution for infusion

DRUGTruxima 500 mg concentrate for solution for infusion

DRUGMabThera 100 mg concentrate for solution for infusion

DRUGRuxience 500 mg concentrate for solution for infusion

DRUGMabThera 500 mg concentrate for solution for infusion

DRUGTruxima 100 mg concentrate for solution for infusion

DRUGRuxience 100 mg concentrate for solution for infusion

DRUGRixathon 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Comparison between both study arms of disease impact (Rheumatoid Arthritis Impact of Disease (RAID) questionnaire) over 104 weeks.	—

Secondary

Measure	Time frame
Comparison between both study arms of disease activity (AUC of the Disease Activity Score in 28-joints - C-reactive Protein (DAS28-CRP)) over 104 weeks., Cumulative dose of rituximab in the two trial arms over 104 weeks., Cumulative dose of glucocorticoids in the two trial arms over 104 weeks., Disease activity (AUC of the Simplified Disease Activity Index (SDAI)) in the two study arms over 104 weeks., Maintenance of disease control (DAS28-CRP ≤3.2) in both study arms., Rituximab drug retention rate in both study arms., Proportion of patients achieving a good/moderate European League Against Rheumatism (EULAR) response 12 weeks after treatment with rituximab in both study arms., Proportion of patients who tapered the dose of rituximab below 1 x 1000 mg IV in the experimental arm., Mean/median interval between administrations of rituximab in the active control arm., Proportion of patients with serious adverse events/reactions in both study arms., Proportion of patients with serious infe	—

Measure

Time frame

Comparison between both study arms of disease activity (AUC of the Disease Activity Score in 28-joints - C-reactive Protein (DAS28-CRP)) over 104 weeks., Cumulative dose of rituximab in the two trial arms over 104 weeks., Cumulative dose of glucocorticoids in the two trial arms over 104 weeks., Disease activity (AUC of the Simplified Disease Activity Index (SDAI)) in the two study arms over 104 weeks., Maintenance of disease control (DAS28-CRP ≤3.2) in both study arms., Rituximab drug retention rate in both study arms., Proportion of patients achieving a good/moderate European League Against Rheumatism (EULAR) response 12 weeks after treatment with rituximab in both study arms., Proportion of patients who tapered the dose of rituximab below 1 x 1000 mg IV in the experimental arm., Mean/median interval between administrations of rituximab in the active control arm., Proportion of patients with serious adverse events/reactions in both study arms., Proportion of patients with serious infe

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Countries

Belgium

Outcome results

None listed