Primary Sjögren Syndrome
Conditions
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.
Interventions
DRUGIguratimod
Iguratimod orally twice a day
DRUGPlacebo
Placebo orally twice a day
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 |
| 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 |
Countries
China
Contacts
Primary ContactLai Zhiqiang
Outcome results
None listed