Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis

NCT06906549 | Recruiting Phase 4

• 2 other identifiers: 94242024-519991-18-00
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis (RA) is a chronic inflammatory disease affecting joints and causing progressive disability. Current treatment strategies involve conventional disease-modifying anti-rheumatic drugs (csDMARDs) and, in more resistant cases, biologic DMARDs (bDMARDs) such as Rituximab. Rituximab, a monoclonal antibody targeting CD20-positive B cells, is administered as an induction dose followed by maintenance therapy every six months. Standard maintenance dosing consists of 1g infusions, but lower doses may provide equivalent efficacy with fewer side effects. The RADAR trial is a multicenter, prospective, randomized, double-blinded, non-inferiority controlled trial designed to evaluate whether a 200 mg maintenance dose of Rituximab every six months is non-inferior to the standard 1g dose in patients with RA who are in low disease activity. The study will assess disease activity using the DAS28-CRP score over 12 months, alongside various secondary endpoints, including treatment failure rates, immune responses, and adverse events. By determining the minimum effective Rituximab dose, the study aims to optimize patient safety, reduce the risk of infections, and lower healthcare costs. This trial is particularly relevant as Rituximab has lost patent protection, making cost-effective treatment crucial, especially in low-resource settings. Findings from this study could lead to updated treatment guidelines, benefiting RA patients worldwide.

Conditions

Rheumatoid Arthritis (RA); Rituximab (RTx)

Keywords

Dose reduction; Low dose Rituximab

Outcome Measures

Primary Outcomes (1)

• Mean reduction of rheumatoid arthritis activity score (DAS28-CRP)

  Mean reduction of rheumatoid arthritis activity score (DAS28-CRP) between inclusion and 12 months to show non-inferiority of the lower dose.

  12 Months

Secondary Outcomes (20)

• Compare the disease activity measured by DAS28-CRP between the two arms

  at inclusion, 6 and 12 months

• DAS28 categories

  at inclusion, 6 months and 12 months

• Number of Rituximab infusions

  12 Months

• Number of patients switching or initiating a cDMARD or switching from Rituximab to another bDMARD

  12 Months

• Number of patients using oral corticosteroids at a dose greater than 10 mg/day

  12 Months

Study Arms (2)

Rituximab 200mg/6months

EXPERIMENTAL

Drug: Rituximab 200mg/6months

Rituximab 1g/6 months

ACTIVE COMPARATOR

Drug: Rituximab 1g/6months

Interventions

Rituximab 200mg/6months DRUG

perfusion of Rituximab 200mg

Rituximab 200mg/6months

Rituximab 1g/6months DRUG

perfusion of Rituximab 1g

Rituximab 1g/6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of rheumatoid arthritis (RA) according to EULAR/ACR 2010 classification criteria
• DAS28 ≤ 5.1
• Current maintenance treatment with Rituximab regardless of dose and/or duration of Rituximab treatment and with at least first cycle of Rituximab ended (2 initial infusions)
• Affiliation to a social insurance system or beneficiary
• Written informed consent to participate in the study, dated and signed before starting the trial
• Effective method of birth control during the study

You may not qualify if:

• Rheumatic autoimmune disease other than RA (except associated Sjogren's disease, which is allowed)
• Concurrent treatment with any other targeted therapy than Rituximab
• Any contraindication to Rituximab or to NaCl 0.9%
• Significant uncontrolled associated disease or comorbidity
• Known active infection or history of serious recurrent or chronic infection
• Laboratory findings: active or untreated latent tuberculosis, hepatitis B positive, hepatitis C positive, haemoglobin \<8 g/dL, neutropenia \< 1.5G/L, IgM \<0.4 g/L and/or IgG \<5 g/L
• Pregnancy, breastfeeding, or planned pregnancy during the study (on subject declaration)
• Drug addiction, alcohol addiction
• Patients who cannot be followed for the 12 month-duration
• Patients over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision
• Patients unable to give informed consent (e.g., patients in a situation of medical emergency, patients who have difficulty comprehending the essential details of the trial...)
• Patients who have difficulty reading or understanding French, or who have an inability to understand the delivered information

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 2, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

FR (1)