A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis
NCT ID: NCT04333771
Last Updated: 2023-11-22
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
PHASE3
566 participants
INTERVENTIONAL
2020-07-31
2023-09-21
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
DOUBLE
Study Groups
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Placebo
Placebo
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
SHR0302 dose1
SHR0302
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
SHR0302 dose2
SHR0302
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
Interventions
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SHR0302
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
Placebo
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
Eligibility Criteria
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Inclusion Criteria
* RA diagnosis consistent with the 2010 ACR/EULAR criteria;
* Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.
* Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.
* If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
* BMI ≥18 kg/m2
Exclusion Criteria
* Lab abnormality within 4 weeks of randomization as follows: WBC count \<3.0×10\^9/L；neutrophil count\<1.5×10\^9/L;hemoglobin level\<90.0 g/L ; platelet count \<100×10\^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
* History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
* Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Liuzhou workers' Hospital
Liuzhou, Guangxi, China
Countries
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References
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Liu J, Jiang Y, Zhang S, Liu S, Su J, Lin C, He X, Wu R, Yang L, Liu H, Duan X, Xu S, Luo H, Liu J, Xie Q, Mi C, Chen L, Zhang N, Gong H, Zhu J, Li Y, Wei H, Qian L, Wang J, Shi X, Jin H, Jiang Z, Xie X, Zhan F, Geng X, Zheng Z, Du Z, Dong G, Sun Y, Zeng X. Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. Ann Rheum Dis. 2025 Feb;84(2):188-200. doi: 10.1136/ard-2024-226385. Epub 2025 Jan 3.
Other Identifiers
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SHR0302-301
Identifier Type: -
Identifier Source: org_study_id