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| Name | Class |
|---|---|
| Fonds voor Wetenschappelijk Reumaonderzoek (FWRO) | UNKNOWN |
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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:
Participants will be randomized to one of two study arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapering of rituximab based on disease activity guided dose reduction | Experimental | Treatment 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. |
|
| Tapering of rituximab based on interval prolongation | Active Comparator | Treatment 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | IV rituximab |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over 2 years (104 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over 2 years (104 weeks) |
| Comparison of disease activity in both study arms, measured using the Simplified Disease Activity Index (SDAI) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of functional status in both study arms, measured using the Health Assessment Questionnaire - Disability Index (HAQ-DI) | HAQ-DI score range: 0 - 3, with higher scores indicating worse functional status. | Over 2 years (104 weeks) |
| Self-efficacy in both study arms, measured using the Arthritis Self-Efficacy Scale (ASES) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Verschueren, MD, PhD | Contact | 016342541 | +32 | patrick.verschueren@uzleuven.be |
| Johan Joly, MSc | Contact | 016340258 | +32 | johan.joly@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Verschueren, MD, PhD | University Hospitals Leuven/KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Jan Palfijn | Not yet recruiting | Merksem | Antwerpen | 2170 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39407334 | Derived | 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. |
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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.
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|
SDAI range: 0 - ..., with higher values indicating higher disease activity. |
| Over 2 years (104 weeks) |
| Comparison of cumulative dose of rituximab in both study arms | Over 2 years (104 weeks) |
| Comparison of cumulative dose of glucocorticoids in both study arms | Over 2 years (104 weeks) |
| 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. | Over 2 years (104 weeks) |
| 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. | Over 2 years (104 weeks) |
| Comparison of rituximab drug retention rate in both study arms | Defined as the percentage of patients remaining on treatment with rituximab over time. | Over 2 years (104 weeks) |
| Proportion of patients tapering rituximab below 1000 mg in the experimental arm | Over 2 years (104 weeks) |
| Mean/median interval between rituximab administrations in the active comparator group | Over 2 years (104 weeks) |
| 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. | Over 2 years (104 weeks) |
| 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. | Over 2 years (104 weeks) |
ASES score range: 11 - 110, with higher scores indicating higher perceived self-efficacy. |
| Over 2 years (104 weeks) |
| Pain in both study arms, measured using a Visual Analogue Scale (VAS) completed by the patient | VAS pain range: 0 - 100, with higher values indicating higher pain | Over 2 years (104 weeks) |
| Fatigue in both study arms, measured using a Visual Analogue Scale (VAS) completed by the patient | VAS fatigue range: 0 - 100, with higher values indicating more fatigue. | Over 2 years (104 weeks) |
| Patient global assessment (PGA) of disease in both study arms, measured using a Visual Analogue Scale (VAS) completed by the patient | VAS PGA range: 0 - 100, with higher values indicating worse disease. | Over 2 years (104 weeks) |
| Cluster of Differentiation (CD) 19+ and Memory B cell counts in both study arms | Determined at baseline, before administration of rituximab and at year 2 (104 weeks) in both study arms. | Over 2 years (104 weeks) |
| Immunoglobulin (Ig) counts (IgG, IgA and IgM) in both study arms | Determined at baseline, before administration of rituximab and at year 2 (104 weeks) in both study arms. | Over 2 years (104 weeks) |
| Professional and vocational participation in both study arms, calculated using the Work Productivity and Activity Impairment questionnaire: General Health (WPAI:GH) | The WPAI:GH calculates the percent work time missed due to health (range 0-100, higher numbers indicating more missed work time), the percent impairment while working due to health (range 0-100, higher numbers indicating higher impairment), the percent overall work impairment due to health (range 0-100, higher numbers indicating higher impairment), and the percent activity impairment due to health (range 0-100, higher numbers indicating higher impairment). | Over 2 years (104 weeks) |
| Health utility index in both study arms, calculated using the summary index score of the EuroQol - 5 dimensions (EQ-5D) questionnaire | Summary index score range: less than 0 (health state worse than dead, 0 being the value of a health state equivalent to death) to 1 (full health). | Over 2 years (104 weeks) |
| Cliniques Universitaires Saint-Luc Bruxelles | Not yet recruiting | Brussels | Brussels Capital | 1000 | Belgium |
|
| Reumacentrum Genk | Recruiting | Genk | Limburg | 3600 | Belgium |
|
| ReumaClinic Genk | Recruiting | Genk | Limburg | 3600 | Belgium |
|
| OLV Aalst | Recruiting | Aalst | Oost-Vlaanderen | 9300 | Belgium |
|
| RZ Heilig Hart | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
|
| University Hospitals Leuven (UZ Leuven) | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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