Clinical trial NCT04830644: A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Primary Sjögren Syndrome
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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:

  1. Rituximab in the past 12 months prior to randomization;
  2. Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization;
  3. Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization;
  4. 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.

Primary outcomes:
measure: Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
timeFrame: Week 12
measure: Change From Baseline in the Unstimulated Salivary Flow
timeFrame: Week 12
measure: Change From Baseline in Schirmer's Test
timeFrame: Week 12
measure: Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM)
timeFrame: Week 12
measure: Change From Baseline in the level of rheumatoid factor (RF)
timeFrame: Week 12
measure: Change From Baseline in the level of B -cell activation factor (BAFF)
timeFrame: Week 12
measure: Change From Baseline in the level of T/B/NK cell subsets
timeFrame: Week 12
measure: Change From Baseline in the level of erythrocyte sedimentation rate (ESR)
timeFrame: Week 12
measure: Change From Baseline in the level of serum complement (C3 and C4)
timeFrame: Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
city: Nanning
country: China
facility: the Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: the Second Hospital of HeBei Medical University
state: Hebei
city: Luoyang
country: China
facility: the First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospitalof Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: the First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Hospital Affliated to Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: the Shanghai Ninth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune hospital
state: Shanxi
city: Taiyuan
country: China
facility: the Second Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: the Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The Second Affiliated Hospital of Jiaxing University
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Wenling
country: China
facility: the First People's Hospital of Wenling
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: