Sjogren's SyndromePhase 4BRRPJSNCT06410833
Belimumab After Rituximab in Resistant Primary Juvenile SS
A Phase 4 study testing Rituximab and Belimumab in people with Sjogren's Syndrome and Pediatric ALL, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Sjogren's Syndrome, Pediatric ALL
- What is being tested?
- Rituximab and Belimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 involvement: polyarthritis, vasculitis, autoimmune cytopenia or involvement of skin, kidney, lung, nerve, and liver. b) constituted B cell activation: elevated IgG, light chain, high β 2MG, C4 decrease, cryoglobulinemia, monoclonal antibody c) sustained increased inflammatory markers, such as ESR
- Agree to receive the treatment of rituximab combined with belimumab
Who cannot join
- 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 antibody positive. Hepatitis C antibody positive. -- Historically positive HIV test or test positive at screening for HIV. -- Active tuberculosis.
- 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 for treatment of infection within 60 days of Day 0. -- Use of parenteral (intravenous or intramuscular) antibiotics (anti-bacterials, antivirals, anti-fungals or anti-parasitic agents) within 30 days of Day 0. -- Receipt of a live-attenuated vaccine within 3 months of Day 0. -- In the investigator's opinion, participants that are at high risk for infection (including but not limited to in dwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent severe urinary tract infection).
- Primary immunodeficiency
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- 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 abnormal laboratory value that places the participant at risk by participating in this trial with the exception of diseases or conditions related to active SS
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hongmei Song, Doctor, +86-10-69156271, songhm1021@hotmail.com
Zhou, +86 01069156251, yzhou11@tsinghua.org.cn
About this study
Official title: Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome
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.
Participants will:
Recieve Rituximab each week for 2-4 times until B%<0.5% or B#<20×10^6/L Recieve Belimumab 4 weeks after the last use of Rituximab, and then every 4 weeks until week 28
- Conditions
- Sjogren's Syndrome, Pediatric ALL
- Being tested
- Rituximab, Belimumab
- Keywords
- Rituximab, Belimumab
- Medical subject headings
- Sjogren's Syndrome, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Rituximab weekly until B%<0.5% or B#<20×10^6/L
BelimumabDrug
Belimumab every four weeks
| Study group | Role | What they receive |
|---|---|---|
| sequential use of rituximab and belimumab | Experimental | Not described Receives: Drug: Rituximab; Drug: Belimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respondence rate
In the context of the aforementioned criteria, a response is defined as the alteration of more than three of the following five indicators: a) Improvement of physician global assessment score by ≥30% b) Decrease in erythrocyte sedimentation rate (ESR) by ≥30% or normalization c) Improvement of B cell activation markers (IgG, RF) by ≥25% d) Improvement of lacrimal gland function: Improvement of Schirmer test by ≥5mm e) Improvement of salivary gland function: Increase in salivary flow rate by 25% or decrease in ultrasound score by ≥25%.
Measured: Week 28
Secondary outcomes (6)
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 28
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Measured: week 0 and 28
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 28
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Measured: week 0 and 28
the Sjögren's Tool for Assessing Response (STAR)
The STAR is a composite responder index that includes 5 items, and the score is from 0 to 9, while more than 5 points means improvement.
Measured: week 28
Schirmer test
Schirmer test is a assay to detect the production of tears and less than 5mm means abnormal.
Measured: Week 0 and 28
salivary flow rate
Salivary flow rate is measured by unstimulated whole saliva. A higher salivary flow rate represents lower disease activity.
Measured: week 0 and 28
Score of salivary ultrasounds
The Hocevar scoring system was used investigating (1) parenchymal echogenicity compared with the thyroid gland, graded 0-1; (2) homogeneity, graded 0-3; (3) presence of hypoechogenicareas, graded 0-3; (4) hyperechogenic reflections, graded 0-3 in parotid glands and 0-1 in submandibular glands; and (5) clearness of the salivary gland border, graded 0-3, in both parotid and submandibular salivary glands. Total ultrasound score was the sum of these five domains and can range from 0 to 48. A higher score usually represents more severe disease.
Measured: week 0 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start9 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, Central South University, Shenzhen Children's Hospital, The First Hospital of Jilin University, Children's Hospital of The Capital Institute of Pediatrics, The Affiliated Hospital of Qingdao University, Children's Hospital of Nanjing Medical University, Children's Hospital of Fudan University, Shengjing Hospital, Shanghai Children's Hospital, Tianjin Children's Hospital
- Responsible party
- Principal investigator, Hongmei Song, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410833
- Sponsor's protocol ID
- K3926
- Acronym
- BRRPJS
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT06410833
- Acronym / sponsor ID
- BRRPJS / K3926
- Conditions
- Sjogren's Syndrome, Pediatric ALL
- Keywords
- Rituximab, Belimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, Central South University, Shenzhen Children's Hospital, The First Hospital of Jilin University, Children's Hospital of The Capital Institute of Pediatrics, The Affiliated Hospital of Qingdao University, Children's Hospital of Nanjing Medical University, Children's Hospital of Fudan University, Shengjing Hospital, Shanghai Children's Hospital, Tianjin Children's Hospital
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Participants will:
Recieve Rituximab each week for 2-4 times until B%<0.5% or B#<20×10^6/L Recieve Belimumab 4 weeks after the last use of Rituximab, and then every 4 weeks until week 28
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sequential use of rituximab and belimumab | Experimental | Drug: Rituximab, Drug: Belimumab |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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 involvement: polyarthritis, vasculitis, autoimmune cytopenia or involvement of skin, kidney, lung, nerve, and liver. b) constituted B cell activation: elevated IgG, light chain, high β 2MG, C4 decrease, cryoglobulinemia, monoclonal antibody c) sustained increased inflammatory markers, such as ESR
- Agree to receive the treatment of rituximab combined with belimumab
Key exclusion criteria (11 listed)
- 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 antibody positive. Hepatitis C antibody positive. -- Historically positive HIV test or test positive at screening for HIV. -- Active tuberculosis.
- 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 for treatment of infection within 60 days of Day 0. -- Use of parenteral (intravenous or intramuscular) antibiotics (anti-bacterials, antivirals, anti-fungals or anti-parasitic agents) within 30 days of Day 0. -- Receipt of a live-attenuated vaccine within 3 months of Day 0. -- In the investigator's opinion, participants that are at high risk for infection (including but not limited to in dwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent severe urinary tract infection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabRituximab weekly until B%<0.5% or B#<20×10^6/L | Drug | sequential use of rituximab and belimumab |
| BelimumabBelimumab every four weeks | Drug | sequential use of rituximab and belimumab |
Primary outcome
Respondence rate
Time frame: Week 28
In the context of the aforementioned criteria, a response is defined as the alteration of more than three of the following five indicators: a) Improvement of physician global assessment score by ≥30% b) Decrease in erythrocyte sedimentation rate (ESR) by ≥30% or normalization c) Improvement of B cell activation markers (IgG, RF) by ≥25% d) Improvement of lacrimal gland function: Improvement of Schirmer test by ≥5mm e) Improvement of salivary gland function: Increase in salivary flow rate by 25% or decrease in ultrasound score by ≥25%.
6 secondary outcomes
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 28
Time frame: week 0 and 28
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 28
Time frame: week 0 and 28
the Sjögren's Tool for Assessing Response (STAR)
Time frame: week 28
Schirmer test
Time frame: Week 0 and 28
salivary flow rate
Time frame: week 0 and 28
Score of salivary ultrasounds
Time frame: week 0 and 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rituximab and Belimumab in people with Sjogren's Syndrome and Pediatric ALL, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhou (+86 01069156251, yzhou11@tsinghua.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respondence rate (time frame: Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.