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Rheumatoid ArthritisPhase 4RITUXERANCT06003283

Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis

A Phase 4 study testing Rituximab in people with Rheumatoid Arthritis, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
7 sitesBelgium
Study dates
9 Jan 2024to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to give written informed consent and participate in the study before any study procedure.
  • Age ≥ 18 years.
  • Understanding and able to write in Dutch or French.
  • Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for rheumatoid arthritis.
  • Previous response to rituximab, defined as a minimum of one successful rituximab cycle (= a moderate/good EULAR response 16 weeks after the first administration of rituximab).
  • Current treatment with rituximab.
  • Need for a subsequent rituximab cycle according to the Belgian reimbursement criteria for the use of rituximab in rheumatoid arthritis (DAS28 score ≥3.2).
  • Stable dose of methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (DMARDs) 4 weeks prior to baseline.

Who cannot join

  • Current treatment with another biological DMARD than rituximab.
  • Current treatment with a targeted synthetic DMARD.
  • Pregnancy or pregnancy wish.
  • Presence of an absolute contraindication to treatment with rituximab, according to the label of rituximab and according to medical judgement.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Patrick Verschueren, MD, PhD contact

016342541 ext. +32

patrick.verschueren@uzleuven.be

Johan Joly, MSc contact

016340258 ext. +32

johan.joly@uzleuven.be

7 sites in 1 country

Belgium7 sites, 7 recruiting

  • OLV Aalst

    Aalst, Oost-Vlaanderen, 9300

    Tom Zwaenepoel, MD

    Recruiting

  • Cliniques Universitaires Saint-Luc Bruxelles

    Brussels, Brussels Capital, 1000

    Patrick Durez, MD, PhD

    Not yet recruiting

  • Reumacentrum Genk

    Genk, Limburg, 3600

    Philip Remans, MD, PhD

    Recruiting

  • ReumaClinic Genk

    Genk, Limburg, 3600

    Johan Vanhoof, MD

    Recruiting

  • RZ Heilig Hart

    Leuven, Vlaams-Brabant, 3000

    Veerle Taelman, MD

    Recruiting

  • University Hospitals Leuven (UZ Leuven)

    Leuven, Vlaams-Brabant, 3000

    Patrick Verschueren, MD, PhD

    Johan Joly, MSc

    Recruiting

  • ZNA Jan Palfijn

    Merksem, Antwerpen, 2170

    Alla Ishchenko, MD

    Not yet recruiting

Other trials in Belgium

About this study

Official title: Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial

The goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis.

The main questions it aims to answer are:

Read more
  • What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact?
  • What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy?

Participants will be randomized to one of two study arms:

  • Tapering based on disease-activity guided dose reduction (experimental arm)
  • Tapering based on interval prolongation (active comparator arm)
Being tested
Rituximab
Keywords
Rheumatoid arthritis, Rituximab, Tapering, Disease impact
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called MabThera, Truxima, Ruxience, Rixathon

    IV rituximab

Study groups in NCT06003283
Study groupRoleWhat they receive
Tapering of rituximab based on disease activity guided dose reductionExperimentalTreatment with rituximab every 6 months (24 weeks) with dosing based on disease activity, measured by the DAS28-CRP. DAS28-CRP ≤ 3.2: dose reduction according to the following sequence: 1 x 1000 mg IV (maximum), 1 x 500 mg IV, 1 x 200 mg IV (minimum). DAS28-CRP > 3.2: administration of previously effective dose.
Receives: Drug: Rituximab
Tapering of rituximab based on interval prolongationActive comparatorTreatment with fixed dose of rituximab (1 x 1000 mg IV) if DAS28-CRP ≥ 3.2 AND interval of at least 6 months (24 weeks) since previous administration of rituximab.
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of disease impact in both study arms, measured using the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire

    RAID questionnaire score range: 0 - 10, with higher scores indicating worse status.

    Measured: Over 2 years (104 weeks)

Secondary outcomes (11)

  1. Comparison of disease activity in both study arms, measured using the Disease Activity Score in 28 joints - C-reactive protein (DAS28-CRP)

    Main secondary outcome. DAS28-CRP range: 0 - ..., with higher values indicating higher disease activity.

    Measured: Over 2 years (104 weeks)

  2. Comparison of disease activity in both study arms, measured using the Simplified Disease Activity Index (SDAI)

    SDAI range: 0 - ..., with higher values indicating higher disease activity.

    Measured: Over 2 years (104 weeks)

  3. Comparison of cumulative dose of rituximab in both study arms

    Measured: Over 2 years (104 weeks)

  4. Comparison of cumulative dose of glucocorticoids in both study arms

    Measured: Over 2 years (104 weeks)

  5. Proportion of patients in both study arms achieving a good or moderate European League Against Rheumatism (EULAR) treatment response after administration of rituximab, over a period of 2 years (104 weeks)

    A good EULAR response is defined as a decrease in Disease Activity Score in 28 joints - C-reactive protein (DAS28-CRP) > 1.2 and a present DAS-CRP ≤ 3.2. A moderate EULAR response is defined as a decrease in DAS28-CRP > 0.6 to ≤ 1.2 and a present DAS28-CRP ≤ 5.1, or a decrease in DAS28-CRP > 1.2 and a present DAS28-CRP > 3.2. Treatment responses will be evaluated 12 weeks after every administration of rituximab.

    Measured: Over 2 years (104 weeks)

  6. Comparison of loss of disease control in both study arms

    Loss of disease control is defined as achieving a Disease Activity Score in 28 joints - C-reactive protein (DAS28-CRP) > 3.2 with previous DAS28-CRP ≤ 3.2.

    Measured: Over 2 years (104 weeks)

  7. Comparison of rituximab drug retention rate in both study arms

    Defined as the percentage of patients remaining on treatment with rituximab over time.

    Measured: Over 2 years (104 weeks)

  8. Proportion of patients tapering rituximab below 1000 mg in the experimental arm

    Measured: Over 2 years (104 weeks)

  9. Mean/median interval between rituximab administrations in the active comparator group

    Measured: Over 2 years (104 weeks)

  10. Comparison of serious adverse events/reactions rates in both study arms.

    An adverse event or adverse reaction is considered serious if it leads to inpatient hospitalization or prolongation of existing hospitalization, if it results in persistent or significant disability or incapacity, if it results in a life-threatening experience (meaning that the subject was at risk of death), or if it results in death.

    Measured: Over 2 years (104 weeks)

  11. Comparison of serious infections rate in both study arms.

    An infection is considered serious if it leads to inpatient hospitalization or prolongation of existing hospitalization, if it results in persistent or significant disability or incapacity, if it results in a life-threatening experience (meaning that the subject was at risk of death), or if it results in death.

    Measured: Over 2 years (104 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start9 Jan 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open label multicenter pragmatic randomized controlled superiority trial. Patients will be 1:1 randomized to either the experimental arm or the active comparator arm. Study visits are scheduled every 12 weeks (3 months). Recruitment period: 1 year. Trial duration: 2 years.
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06003283
Sponsor's protocol ID
S67309
Acronym
RITUXERA
Status last verified
May 2025
First submitted
19 Jul 2023
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • De Meyst E, Bertrand D, Joly J, Doumen M, Marchal A, Thelissen M, Neerinckx B, Westhovens R, Verschueren P. Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: study protocol for a multicentre randomised controlled superiority trial focusing on long-term disease impact (RITUXERA). Trials. 2024 Oct 15;25(1):681. doi: 10.1186/s13063-024-08542-7.

    PubMed 39407334

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rituximab in people with Rheumatoid Arthritis, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patrick Verschueren, MD, PhD (016342541 ext. +32, patrick.verschueren@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of disease impact in both study arms, measured using the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire (time frame: Over 2 years (104 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06003283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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