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New treatment option for Rheumatoid Arthritis (RA)
Official title Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06906549
What this study is testing
What is Rituximab 200mg/6months?
Rituximab 200mg/6months is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Last Rituximab infusion between 6 and 18 months prior to inclusion
You likely can't join 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 \<...
See the full eligibility criteria
- 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)
- Last Rituximab infusion between 6 and 18 months prior to inclusion
- Corticosteroids ≤10 mg/day within 4 weeks prior to inclusion
- 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
- 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
- Subject in exclusion period (determined by a previous or ongoing study)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.