A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.
NCT ID: NCT04830644
Last Updated: 2021-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
144 participants
INTERVENTIONAL
2021-03-22
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iguratimod 1
orally 25mg twice a day
Iguratimod
Iguratimod orally twice a day
Iguratimod 2
orally 20mg twice a day
Iguratimod
Iguratimod orally twice a day
Iguratimod 3
orally 10mg twice a day
Iguratimod
Iguratimod orally twice a day
Placebo
orally twice a day
Placebo
Placebo orally twice a day
Interventions
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Iguratimod
Iguratimod orally twice a day
Placebo
Placebo orally twice a day
Eligibility Criteria
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Inclusion Criteria
* ESSDAI score ≥6
* IgG \>16 g/L
* Positive anti-SS-A/Ro antibody at screening
Exclusion Criteria
* Secondary Sjogren's syndrome
* severe renal or haematological failure, a history of cancer, hepatitis B or C, human immunodeficiency virus, severe diabetes or any other chronic disease or evidence of infection
* Prior administration of any of the following:
1. Rituximab in the past 12 months prior to randomization;
2. Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization;
3. Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization;
4. live vaccine in the past 12 weeks prior to randomization
* Corticosteroids: \> 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to randomization; Intramuscular, subcutaneous, intravenous, or intra-articular corticosteroids within 4 weeks prior to randomization.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
the Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Hebei General Hospital
Shijiazhuang, Hebei, China
the Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, China
the First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Hospitalof Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jilin Province People's Hospital
Changchun, Jilin, China
the First Hospital of Jilin University
Changchun, Jilin, China
Shandong Provincial Hospital Affliated to Shandong First Medical University
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
the Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Shanxi Bethune hospital
Taiyuan, Shanxi, China
the Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
the Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
the First People's Hospital of Wenling
Wenling, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zhanguo Li
Role: primary
Guixiu Shi
Role: primary
Min Yang
Role: primary
Yingqian Mo
Role: primary
Meiling li
Role: primary
Fengxiao Zhang
Role: primary
Hongtao Jin
Role: primary
Xiaofei Shi
Role: primary
Wenqiang Fan
Role: primary
Shengyun Liu
Role: primary
Fen Li
Role: primary
Ning Tie
Role: primary
Lei Gu
Role: primary
Lingyun Sun
Role: primary
Lin Chen
Role: primary
Zhenyu Jiang
Role: primary
Hongsheng Sun
Role: primary
Huaxiang Liu
Role: primary
Futao Zhao
Role: primary
Jianping Tang
Role: primary
Huiping Gong
Role: primary
Liyun Zhang
Role: primary
Xiaoxia Wang
Role: primary
Xueyi Li
Role: primary
Wufang Qi
Role: primary
Yasong Li
Role: primary
Qiao Ye
Role: primary
Xiudi Wu
Role: primary
Yongjun Cheng
Role: primary
Li Sun
Role: primary
Other Identifiers
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SIM 1910-08-Ⅱ
Identifier Type: -
Identifier Source: org_study_id
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