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Effect of Iguratimod on Primary Sjogren's Syndrome

Observation of Iguratimod's Effect on Primary Sjogren's Syndrome, A randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021345
Enrollment
Unknown
Registered
2019-02-16
Start date
2019-02-12
Completion date
Unknown
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogren's Syndrome

Interventions

Control group :Hydrochloroquine
Treatment group:Iguratimod

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. All cases included should comply with the 2002 American Rheumatic Society Sjogren's syndrome classification criteria and at the same time comply with serum IgG = 16 g/L; 2. Blood creatinine and transaminase levels are normal; 3. Aged between 18 and 75 years; 4. Contraception during the period of consent of the birth patient and within six months after the end of the trial.

Exclusion criteria

Exclusion criteria: 1. Retinopathy; 2. The use of biological agents or immunosuppressants other than hydroxychloroquinone, oral anticoagulants, alcohol or substance abuse during the first three months of the group; 3. Having received radiation therapy at the neck of the head; 4. Merging other connective tissue diseases; 5. Cognitive impairment, inability to communicate independently; 6. Subjects who use powerful anti-cholinergic drugs such as tricyclic antidepressants and parathosensory stimulants, antihistamines, phenothiazine, and Kangpajinsen drugs are not allowed to participate in the study; 7. There are serious cardiovascular disorders, arrhythmias, congestive heart failure, and lung disease(FVC ), blood system disorders, mikulicz disease, sarcoidosis, diabetes, and transplant rejection patients; 8. Potential, chronic or persistent infections that may be aggravated by immunosuppressive therapy; 9. Cancer history; 10. Exclusion of pregnant and lactating patients; 11. Live vaccine received in the past three months.

Design outcomes

Primary

MeasureTime frame
IgG;Parotid gland B ultrasound;Breg;CRP;Blood routine;autoantibody profile;A - cell - contrast protein antibody;Chest HRCT;Lung function;Renal tubular acidification;Th17;Treg;Tfh;Tfr;—

Secondary

MeasureTime frame
ESR;Tumor markers;routine urine test;stool routine;liver function;Renal function;electrolyte;Abdominal ultrasound;Ultrasound Cardiogram;—

Countries

China

Contacts

Public ContactWei Wei

Tianjin Medical University General Hospital

tjweiwei2003@163.com+86 022 60361025

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026