A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Iguratimod in Patients With Active Primary Sjogren's Syndrome.
1 other identifier
interventional
144
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2021
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2021
CompletedFirst Submitted
Initial submission to the registry
March 28, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 19, 2021
July 1, 2021
1 year
March 28, 2021
July 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. Overall score, which can range from 0 to 123, a higher score indicates more disease activity
Week 12
Secondary Outcomes (9)
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Week 12
Change From Baseline in the Unstimulated Salivary Flow
Week 12
Change From Baseline in Schirmer's Test
Week 12
Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM)
Week 12
Change From Baseline in the level of rheumatoid factor (RF)
Week 12
- +4 more secondary outcomes
Study Arms (4)
Iguratimod 1
EXPERIMENTALorally 25mg twice a day
Iguratimod 2
EXPERIMENTALorally 20mg twice a day
Iguratimod 3
EXPERIMENTALorally 10mg twice a day
Placebo
PLACEBO COMPARATORorally twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Peking University People's Hospital
Beijing, Beijing Municipality, 100032, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510000, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000, 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, 410000, China
The Affiliated Hospitalof Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jilin Province People's Hospital
Changchun, Jilin, 130000, China
the First Hospital of Jilin University
Changchun, Jilin, China
Shandong Provincial Hospital Affliated to Shandong First Medical University
Jinan, Shandong, 250021, 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, 314000, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
the First People's Hospital of Wenling
Wenling, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2021
First Posted
April 5, 2021
Study Start
March 22, 2021
Primary Completion
April 1, 2022
Study Completion
June 1, 2022
Last Updated
July 19, 2021
Record last verified: 2021-07