A Study of Iguratimod in Patients With Active Rheumatoid Arthritis
NCT ID: NCT01554917
Last Updated: 2020-10-14
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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COMPLETED
PHASE4
1759 participants
INTERVENTIONAL
2012-05-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Iguratimod
Iguratimod
taken orally, 2 tablets/day (bid)
Interventions
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Iguratimod
taken orally, 2 tablets/day (bid)
Eligibility Criteria
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Inclusion Criteria
* Subjects who have active RA at the time of screening
* Subjects who haven't used any antirheumatic drugs or have used antirheumatic drugs for more than 3 months at the time of screening
* Written informed consent
Exclusion Criteria
* Pregnant or lactating women
* ALT\>1.5×ULN, AST\>1.5×ULN, Cr\>135umol/L
* WBC\<4×109/L，HGB\<85g/L，PLT\<100×109/L
* Subjects with uncontrolled infection
* Patients with active gastrointestinal diseases (such as gastric ulcer, etc.)
* Allergic to any of the study drugs
* History of alcoholism
* Subjects receiving live vaccines within 3 months prior to study entry
* Subjects participating in other clinical study within 3 months prior to study entry
18 Years
ALL
No
Sponsors
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Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhanguo Li, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Peking University People's Hospital
Beijing, , China
Countries
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References
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Mu R, Li C, Li X, Ke Y, Zhao L, Chen L, Wu R, Wu Z, Zuo X, Xie Y, Chen J, Wei W, Liu Y, Li Z, Dai L, Sun L, Liu X, Li Z. Effectiveness and safety of iguratimod treatment in patients with active rheumatoid arthritis in Chinese: A nationwide, prospective real-world study. Lancet Reg Health West Pac. 2021 Mar 22;10:100128. doi: 10.1016/j.lanwpc.2021.100128. eCollection 2021 May.
Other Identifiers
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SIM-109
Identifier Type: -
Identifier Source: org_study_id
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