The aim of this study is to investigate non-inferiority of rituximab SC 336 mg to rituximab IV 200 mg.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is non-inferiority of rituximab 336 mg SC to 200 mg IV,
with the AUC0-6mnd,SC : AUC0-6mnd,IV exceeding 0.8.
Secondary outcome
Secondary outcomes include additional pharmacokinetic parameters, changes in
disease activity, changes in quality of life, suppression of B-cells, presence
of anti-drug antibodies, adverse events and patient preferences.
Background summary
Recently, the REDO-study has been performed, demonstrating a good response on
continued treatment with f ultra-low dose rituximab (1x 500 or 1x 200 mg) in a
large proportion of rheumatoid arthritis (RA) patients.1 To further optimize
rituximab treatment in terms of patient friendliness and organization of care,
subcutaneous administration should be explored.
Study objective
The aim of this study is to investigate non-inferiority of rituximab SC 336 mg
to rituximab IV 200 mg.
Study design
Randomised parallel open-label non-inferiority trial
Intervention
Patients will be randomised to rituximab 336 mg subcutaneously or 200 mg
intravenous 4-5 months after having received their last dose of rituximab.
Randomization will be stratified to the previous rituximab dose (200 or 500 mg)
and the use of a concomitant DMARD (combination therapy or monotherapy RTX).
Study burden and risks
The risks in this study include adverse events to rituximab SC and risk of a
flare-up of the rheumatoid arthritis. Since patients already receive treatment
with (ultra-) low dose rituximab, the chance of additional systemic adverse
events and infusion reactions will be absent. Injection site reactions can be
expected.
In case the bioavailability is lower than expected, an increase in RA disease
activity might occur. Then an extra visit will be planned where disease
activity will be measured and extra treatment will be given, if necessary.
Potential benefits of this study include the chance of an injection instead of
infusion therapy, which reduces burden of time and co-medication.
Overall, the risks expected in this study are small and manageable.
Hengstdal 3
Ubbergen 6574NA
NL
Hengstdal 3
Ubbergen 6574NA
NL
Listed location countries
Age
Inclusion 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
- Previous non-response to ultra-low dose rituximab (DAS28-CRP > 2.9);
- Objection or contraindication to either of the treatment options.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002507-19-NL |
| CCMO | NL74149.091.20 |