A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.
- Registration Number
- NCT04830644
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 144
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iguratimod 1 Iguratimod orally 25mg twice a day Iguratimod 2 Iguratimod orally 20mg twice a day Iguratimod 3 Iguratimod orally 10mg twice a day Placebo Placebo orally twice a day
- Primary Outcome Measures
Name Time Method Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) Week 12 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
- Secondary Outcome Measures
Name Time Method Change From Baseline in the level of T/B/NK cell subsets Week 12 The change from baseline in the level of T/B/NK cell subsets at all measured time points up to Week 12
Change From Baseline in the level of B -cell activation factor (BAFF) Week 12 The change from baseline in the level of BAFF at all measured time points up to Week 12
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Week 12 The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.
Total Score Range (0 = Best outcome and 10 = Worst Outcome)
The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM) Week 12 The change from baseline in the level of immunoglobulin (IgG, IgA, IgM) at all measured time points up to Week 12
Change From Baseline in the Unstimulated Salivary Flow Week 12 The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Week 12
Change From Baseline in Schirmer's Test Week 12 The Mean change from baseline in Schirmer's Test at all measured time points up to Week 12
The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.Change From Baseline in the level of rheumatoid factor (RF) Week 12 The change from baseline in the level of RF at all measured time points up to Week 12
Change From Baseline in the level of erythrocyte sedimentation rate (ESR) Week 12 The change from baseline in the level of ESR at all measured time points up to Week 12
Change From Baseline in the level of serum complement (C3 and C4) Week 12 The change from baseline in the level of serum complement (C3 and C4) at all measured time points up to Week 12
Trial Locations
- Locations (30)
Southern Medical University Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Tianjin First Central Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, 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
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Affiliated Hospitalof Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
the First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
the Shanghai Ninth People's Hospital
🇨🇳Shanghai, Shanghai, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, Shanxi, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Shanxi Bethune hospital
🇨🇳Taiyuan, Shanxi, China
the Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, 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
Xinxiang Central Hospital
🇨🇳Xinxiang, Henan, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Shandong Provincial Hospital Affliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
the Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China