Sjogren's Syndrome
Conditions
Keywords
Sjogren's Syndrome, Iguratimod
Brief summary
A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome
Detailed description
In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.
Interventions
DRUGIguratimod
Iguratimod 25 mg orally twice a day for 24 weeks
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria * Positive dry eyes and (or) dry mouth symptoms * Hyperglobulinemia
Exclusion criteria
* Complicated with other systemic autoimmune diseases * Severe complications of Sjogren's syndrome * Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit * Active infections or chronic infectious diseases * A history of malignancies * Pregnancy or breathfeeding * Inability to comply with the study protocol for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ESSDAI improvement | week 24 | The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks. |
| ESSPRI improvement | week 24 | The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 | week 24 | The change from baseline in SF-36 score at 24 weeks. |
| HAQ | week 24 | The change from baseline in HAQ score at 24 weeks. |
| Unstimulated salivary flow rate | week 24 | The change from baseline in unstimulated salivary flow rate at 24 weeks. |
| Rheumatoid Factors | week 24 | The change from baseline in titer of rheumatoid factors at 24 weeks. |
| Immunoglobulins | week 24 | The change from baseline in IgG, IgM and IgA levels at 24 weeks. |
| Schimer's test | week 24 | The change from baseline in Schimer's test at 24 weeks. |
Countries
China
Contacts
Primary ContactHua Chen, Dr.
Outcome results
None listed