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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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15 July 2019 |
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Main ID: |
ChiCTR1900024261 |
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Date of registration:
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2019-07-03 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China
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Scientific title:
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Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China |
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Date of first enrolment:
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2019-07-15 |
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Target sample size:
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A:30;B:30; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=40346 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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Xiaofeng Li
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Address:
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382 Wuyi Road, Taiyuan, China.
030001
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Telephone:
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+86 13753139859 |
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Email:
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lxf_9859@sxmu.edu.cn |
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Affiliation:
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The Second Hospital of Shanxi Medical University |
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Name:
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Hongqing Niu
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Address:
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382 Wuyi Road, Taiyuan, China.
030001
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Telephone:
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+86 15003404859 |
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Email:
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nhqgjmail@163.com |
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Affiliation:
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The Second Hospital of Shanxi Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Newly diagnosed patients with aged 18 to 65 years who meet the Aerican College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria;
2. DAS28 score > 3.2;
3. Hemoglobin >=85g/L, white blood cells>=4*10^9/L, neutrophil count>=1.5*10^9/L, platelet>=100*10^9/L
4. Aminotransferase <=1.5 folds of upper limit of normal, creatinine<=120 mol/L (<=1.4 mg/dl);
5. Patients with good compliance and can regularly return to visit.
Exclusion criteria: 1. Patients who are allergic to sirolimus, sirolimus derivative or any other ingredients, or have recently received steroids, disease modifying anti-rheumatic drugs, or biological agents are excluded.
2. Patients who have other arthritis or autoimmune diseases, active infection, severe hypertension or cardiopulmonary insufficiency, epilepsy or nervous disorder, history of malignant tumor are not included.
3. Female patients who are during pregnancy and lactation, or plan to be pregnant in one year are excluded.
4. Other cases who may not complete the study or will take risks also are excluded.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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rheumatoid arthritis
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Intervention(s)
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A:methotrexate (7.5~15 mg/week)+ placbo (1 mg/d);B:sirolimus (1 mg/d) + methotrexate (7.5~15 mg/week);
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Primary Outcome(s)
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ACR20;DAS28;HAQ;
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Secondary Outcome(s)
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immunologic function;CD4+ T cell subsets;Cytokines detection;
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Source(s) of Monetary Support
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North China Pharmaceutical Co.,Ltd.
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Ethics review
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Status: Approved
Approval date: 23/05/2019
Contact:
Jing Gao
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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