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New treatment option for Sjogren's Syndrome
Official title Belimumab After Rituximab in Resistant Primary Juvenile SS
ClinicalTrials.gov ID: NCT06410833
What this study is testing
What is Rituximab?
Rituximab is an investigational medicine, given as an once-weekly, being studied as a potential treatment for sjogren's syndrome.
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
- The goal of this clinical trial is to explore the effectiveness of sequential use of rituximab and belimumab in the treatment of resistant primary juvenile Sjogren's syndrome. Does sequential use of rituximab and belimumab reduce the activity of SS in resistant patients Researchers will compare the disease activity before and after the treatment of sequential use of rituximab and belimumab to see if the therapy works to treat SS.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 18
You may be able to join if
- Age 5-18 years old.
- Meets SS diagnostic AECG criteria or Japan criteria.
- classification for "resistant patients": Application of two or more immunosuppressants or prednisone +immunosuppressive therapy for more than 3...
- Agree to receive the treatment of rituximab combined with belimumab
You likely can't join if
- Previously treated with rituximab within six months, or previously treated with other biologics, including belimumab or Telitacicept
- Participate in other clinical trials within 6 months
- eGFR\<30ml/min
- Active infections, including but not limited to: -- Current or past infection with hepatitis B or C as defined by: Hepatitis B surface antigen...
- Infection history: -- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes...
- Primary immunodeficiency
See the full eligibility criteria
- Age 5-18 years old.
- Meets SS diagnostic AECG criteria or Japan criteria.
- classification for "resistant patients": Application of two or more immunosuppressants or prednisone +immunosuppressive therapy for more than 3 months. One of the following conditions still exists: a) systemic...
- Agree to receive the treatment of rituximab combined with belimumab
- Previously treated with rituximab within six months, or previously treated with other biologics, including belimumab or Telitacicept
- Participate in other clinical trials within 6 months
- eGFR\<30ml/min
- Active infections, including but not limited to: -- Current or past infection with hepatitis B or C as defined by: Hepatitis B surface antigen positive. Hepatitis B surface antibody positive and hepatitis B core...
- Infection history: -- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) -- Hospitalisation...
- Primary immunodeficiency
- History of malignant neoplasm
- Severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, pulmonary, cardiac or neurological disease or, in the investigator's opinion, any other concomitant medical condition or significant...
- Comorbidities not SS related currently requiring systemic corticosteroid therapy.
- Within 10 days before the first administration of Belimumab, IgG\<4g/L or IgA\<0.1g/L
- WBC\<1.5 × 109/L within 10 days before the first administration of Belimumab or neutrophils\<1 × 109/L
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.