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Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age

Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age - Mizoribine for Sjogren's syndrome in pediatric age

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004237
Enrollment
5
Registered
2010-09-19
Start date
2013-03-31
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Sjogren&#39

Interventions

Mizoribine 10 mg/kg (up to 500 mg) will be administered once daily twice a week.

Sponsors

Graduate School of Medicine, Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with primary Sjogren's syndrome fulfill the revised diagnostic criteria for Sjogren's syndrome of the Ministry of Health and Welfare (1999)

Exclusion criteria

Exclusion criteria: 1. Patients with a history of mizoribine use 2. Patients with a white blood cell count of not more than 3,000 / mm3 3. Pregnant women or women who may become pregnant and women who wish to become pregnant during the course of the study 4. Patients who used cevimeline hydrochloride hydrate, pilocarpine hydrochloride and anetholtrithion within the 4 week period before the start of the study 5. Patients using other immunosuppressive drugs and anti-rheumatoid drugs 6. Other patients who were judged to be ineligible for the study by an attending physician

Design outcomes

Primary

MeasureTime frame
Change of saliva production Change of data of laboratory examinations

Secondary

MeasureTime frame
Change of salivary function, change of subjective symptoms, change of data of laboratory examinations, gastrointestinal symptoms

Countries

Japan

Contacts

Public ContactMinako Tomiita

Graduate School of Medicine, Chiba Universitity Department of Pediatrics

m.tomiita@gmail.com043-226-2144

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026