Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Primary Sjögren Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren's Syndrome.
Eligibility Criteria
Inclusion
- meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjogren's Syndrome (EULAR SS)
- ESSDAI score ≥6
- IgG \>16 g/L
- Positive anti-SS-A/Ro antibody at screening
Exclusion
- Pregnancy or breast feeding
- 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:
- Rituximab in the past 12 months prior to randomization;
- Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization;
- Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization;
- 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04830644
Start Date
March 22 2021
End Date
June 1 2022
Last Update
July 19 2021
Active Locations (30)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100032
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
3
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China, 510000
4
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000