A Phase II study of CA-702 in Patients with Sjogren's Syndrome
- Conditions
- Primary Sjogren's Syndrome
- Registration Number
- JPRN-jRCT2073210083
- Lead Sponsor
- Seki Makoto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Diagnosed with primary Sjogren's Syndrome according to diagnostic criteria by Ministry of Health, Labour and Welfare Japan or ones by ACR- EULAR.
- Have subjective symptom of xerostomia.
- Amount of saliva assessed by Saxon's test is within a certain range.
- Ineffectiveness or intolerance to existing drugs(muscarinic agonists)
Diagnosed with secondary Sjogren's Syndrome or suspected to be.
Diagnosed with IgG4-related disease or suspected to be.
Only anti-centromere antibodies are positive.
Incapable of performing Saxon's test.
Blood test related to virus infections is positive.
Amount of saliva is suspected to be decreased by other than Sjogren's Syndrome.
Have had injection of E-MNC already.
Have participated in a clinical study of unapproved drug, medical product or medical device within 6-month before this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in amount of saliva assessed by Saxon's test from baseline
- Secondary Outcome Measures
Name Time Method