Sjogren's Syndrome study: Rituximab vs Belimumab
Official title Belimumab After Rituximab in Resistant Primary Juvenile SS
ClinicalTrials.gov ID: NCT06410833
What this study is testing
What is Rituximab?
An investigational weekly injectable medicine being studied for resistant primary juvenile Sjogren's syndrome. It is designed to target and reduce B cells in the body.
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 study wants to see whether giving rituximab first and then belimumab later can lower disease activity in children whose Sjögren’s syndrome does not respond to usual treatments.
- Who it's for
- Children with primary juvenile Sjögren’s syndrome that has not improved with other therapies.
- What's involved
- Participants receive rituximab once a week for 2 to 4 doses until a blood test shows a low B‑cell count. Four weeks after the last rituximab dose, they start belimumab, which is given every four weeks until week 28. Blood tests and clinical assessments are done to track disease activity.
- Time commitment
- The treatment period lasts about 28 weeks, with regular clinic visits for drug infusions and monitoring.
- 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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Beijing, Beijing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.