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| Name | Class |
|---|---|
| Children's Hospital of Chongqing Medical University | OTHER |
| Central South University | OTHER |
| Shenzhen Children's Hospital | OTHER_GOV |
| The First Hospital of Jilin University |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequential use of rituximab and belimumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab weekly until B%<0.5% or B#<20×10^6/L |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou | Contact | +86 01069156251 | yzhou11@tsinghua.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C511911 | belimumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| OTHER |
| Children's Hospital of The Capital Institute of Pediatrics | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Children's Hospital of Nanjing Medical University | OTHER |
| Children's Hospital of Fudan University | OTHER |
| Shengjing Hospital | OTHER |
| Shanghai Children's Hospital | OTHER |
| Tianjin Children's Hospital | OTHER |
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| Belimumab | Drug | Belimumab every four weeks |
|
| 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. | 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. | week 28 |
| Schirmer test | Schirmer test is a assay to detect the production of tears and less than 5mm means abnormal. | 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. | 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. | week 0 and 28 |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |