Research into administration of lower dosed rituximab using an injection in patients with Rheumatoid Arthritis

Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20186

Enrollment

Registered

2020-09-08

Start date

2020-10-04

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Rituximab 336 mg subcutaneous (MabThera 1400 mg solution for subcutaneous injection (120 mg/ml:11.7 ml)

Rituximab 200 mg intravenous (Rixathon 100 mg concentrate for solution for infusion)

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Rheumatoid arthritis: either 2010 EULAR/ACR RA17 and/or 1987 ACR RA18 criteria and/or clinical diagnosis of the treating rheumatologist; • Patients using rituximab in ultra-low dose: either 200 mg or 500 mg as previous dose, given every 6 months, with or without concomitant methotrexate; • Having sufficient response to rituximab treatment, operationalized as a DAS28-CRP <2.9 3-6 months after the last infusion and/or judgment of low disease activity by the treating rheumatologist; • =16 years old and mentally competent; • Ability to read and communicate well in Dutch.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Previous non-response to ultra-low dose rituximab (DAS28-CRP > 2.9); • Objection or contraindication to either of the treatment options;

Design outcomes

Primary

Measure	Time frame
To investigate non-inferiority of rituximab SC 336 mg to rituximab IV 200 mg, with the lower boundary of the 95% confidence interval of AUC0-6mnd,SC : AUC0-6mnd,IV exceeding the non-inferiority margin of 0.8.	—

Secondary

Measure	Time frame
• To describe the relevant pharmacokinetic parameters of rituximab 336 mg SC compared to 200 mg IV: peak level, trough level, Cavg; • To evaluate the between group difference in changes in disease activity (DAS28-CRP) after 6 months, compared to a NI margin of 0.6; • To evaluate the between group differences on B-cell counts; • To assess the differences in incidence of anti-drug antibodies (ADAs); • To assess the incidence of AEs in both groups; • To assess patient preferences for either SC or IV formulation.	—

Measure

Time frame

• To describe the relevant pharmacokinetic parameters of rituximab 336 mg SC compared to 200 mg IV: peak level, trough level, Cavg; • To evaluate the between group difference in changes in disease activity (DAS28-CRP) after 6 months, compared to a NI margin of 0.6; • To evaluate the between group differences on B-cell counts; • To assess the differences in incidence of anti-drug antibodies (ADAs); • To assess the incidence of AEs in both groups; • To assess patient preferences for either SC or IV formulation.

—

Contacts

Public ContactCeleste van der Togt

Sint Maartenskliniek

C.vanderTogt@maartenskliniek.nl024 3272793

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)